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a b/clusters/3009knumclusters/clust_139.txt
1
Opportunistic infection within the last 3 months
2
Have an expected survival of ?3 months.
3
Participants may not have current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting study drugs
4
History of arterial thrombotic or embolic events (within 6 months prior to study entry)
5
Subject or subject's partner is willing to use condoms for 12 months after receiving Toca 511 or until there is no evidence of the virus in his/her blood, whichever is longer.
6
Hemoptysis (> ½ teaspoon [2.5 mL] of bright red blood) within 6 months prior to randomization
7
Peptic ulcer within the past 3 months prior to randomization, unless treated for the condition and complete resolution has been documented by esophagogastroduodenoscopy (EGD)
8
Ipsilateral diagnostic mammogram within 12 months of enrollment
9
Part A2: Patients must be >= 6 months and < 12 months of age at the time of study enrollment; patients will enroll one dose level behind the dose level at which patients in Part A1 are enrolling
10
Mammographic finding of BIRADS 4 or greater within 6 months of registration at site other than that of known DCIS, without pathologic assessment
11
History of hospitalization in past 12 months for diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic nonketotic syndrome (HHNS)
12
Patients must not have had hemoptysis of >= 0.5 teaspoon (2.5 ml) of red blood within 3 months prior registration
13
No history of the following:\r\n* Clinically-significant gastrointestinal bleeding within 6 months prior to registration\r\n* Hemoptysis of >= 0.5 teaspoon (2.5 mL) of red blood within 3 months prior to registration\r\n* Drug induced pneumonitis within 3 months prior to registration\r\n* Signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment\r\n* Radiographic evidence of cavitating pulmonary lesion(s)\r\n* Tumor invading any major blood vessels\r\n* Evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or mainstem endobronchial tumor within 28 days before the first dose of cabozantinib
14
NO hepatic artery embolization or cryoablation/radiofrequency ablation of hepatic metastasis within 2 months of study treatment start
15
No prior taxane therapy =< 6 months, except as a radiosensitizer
16
Use of over the counter (OTC) PPIs within 6 months prior to study entry\r\n* Esomeprazole (Nexium)\r\n* Lansoprazole (Prevacid)\r\n* Omeprazole (Prilosec, Zegerid)
17
History of bleeding esophageal varices in previous 6 months, which have not been adequately managed with banding or sclerotherapy.
18
History of peptic ulcer disease within 3 months of treatment.
19
History of hepatitis B (HBV) with surface antigen (HBsAg) positivity within 3 months prior to the date of informed consent for this study (if no test has been performed within 3 months, it must be done at screening);
20
History of hepatitis C (HCV) with HCV RNA positivity within 3 months prior to the date of informed consent for this study (if no test has been performed within 3 months it must be done at screening);
21
Subjects must be age >12 months at enrollment
22
Symptomatic bowel obstruction within 6 months prior to screening visit
23
Systemic treatment with interferon (IFN)-? within the previous 6 months.
24
Unstable angina pectoris </=6 months prior to enrollment
25
History of gastrointestinal perforation and/or fistulae within 6 months prior to initiation of study treatment;
26
Expected survival >= 3 months after consenting
27
Anticancer Vaccine -2 months NOTE: The subject should be excluded if the Investigator considers their disease is responding to an experimental vaccine given within 6 months
28
Prior treatment with docetaxel within 6 months of study enrollment
29
Patients who had therapeutic paracentesis of ascites (> 1L) within the 3 months prior to starting study treatment or who, in the opinion of the investigator, will likely need therapeutic paracentesis of ascites (> 1L) within 3 months of starting study treatment.
30
History of gastrointestinal bleeding, gastric stress ulcerations, or peptic ulcer disease within the past 3 months prior to randomization that, in the investigator's opinion, may place the patient at risk of side effects from anti-angiogenesis products.
31
Significant intercurrent illness that will limit the patient's ability to participate in the study or may result in their death over the next 18 months
32
Recurrence of BCG unresponsive Ta/T1 disease > 6 months after last BCG instillation or BCG unresponsive CIS > 12 months after last BCG instillation.
33
Unstable angina within 6 months prior to study entry,
34
Agreement of both the Chow et al. and type of cancer, ECOG performance status, age, prior palliative chemotherapy, prior hospitalizations, and hepatic metastases (TEACHH) models, indicating a median life expectancy of > 3 months
35
Life expectancy of > 3 months as defined by agreement of both the Chow et al. and TEACHH models
36
Subject is a female who is pregnant or breast-feeding, or intends to become pregnant during their participation in the study (including up to 6 months after the last dose of IMP) or is a male who intends to father a child during their participation in the study (including up to 6 months after the last dose of IMP);
37
Hospitalization for bowel obstruction within 3 months prior to enrollment
38
Must be on a multi-drug anti-HIV regimen (excluding zidovudine [AZT, ZDV, Retrovir], or agents containing zidovudine [e.g., Combivir and Trizivir], and efavirenz [Sustiva], or agents containing efavirenz [e.g., Atripla]), and have an HIV-1 viral load < 50 copies/mL by reverse transcriptase-polymerase chain reaction (RT-PCR) within 6 months prior to study enrollment; for patients who have had negative viral loads in the past 6 months and no known HIV viral load (VL) > 500 copies/mL within the past 6 months, minor fluctuations of viral load (isolated escalations up to 500 copies/mL) are acceptable; the participant's history of negative viral loads may be documented with recent laboratory results and/or a record from the participant's HIV care provider; participants on zidovudine [AZT, ZDV, Retrovir; including Combivir and Trizivir] and efavirenz [Sustiva; including Atripla] must switch to an alternative regimen without anticipated drug-drug interactions or myelosuppressive properties based on known viral resistance patterns and/or ART history, such as raltegravir and Truvada (emtricitabine and tenofovir) at least two weeks prior to the transplant
39
Participants with persistently low CD4 counts less than 200 and a history of any acquired immune deficiency syndrome (AIDS)-defining infection in the last 6 months before screening are excluded from the study
40
Seizures within the past 12 months before enrollment
41
Must have an expected survival of at least three months.
42
Grade ?2 ventricular arrhythmia ?6 months prior to Day 1
43
Patients must be within 12 months of initiation of induction therapy and must have had not more than 2 prior induction regimens
44
Prior carboplatin allowed provided greater than 12 months (mos) have elapsed since last dose of carboplatin
45
Prior taxane is allowed (as long as the patient is not experiencing grade > 1 neuropathy and had no history of disease progression on a taxane therapy within 3 months prior to study enrollment)
46
Active malignancies within 12 months with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
47
Ongoing therapy with nonsteroidal anti-inflammatory drugs for more than 2 months.
48
History of any arterial thrombotic event within 6 months prior to enrollment.
49
Agree not to donate sperm until 6 months after the last dose of OPN-305
50
At least 4 months since completion of curative therapy, if given previously
51
The subject has experienced any of the following:\r\n* Clinically-significant GI bleeding within 6 months before the first dose of cabozantinib\r\n* Hemoptysis of >= 0.5 teaspoon (2.5 ml) of red blood within 3 months before the first dose of cabozantinib\r\n* Any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of cabozantinib
52
History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
53
PIK3CA WILD TYPE COHORT (closed 03/17/2016): Life expectancy > 4 months
54
Syncope without known aetiology within 3 months
55
The majority of the anticipated target volume (> 50%) must have been previously treated to >= 40 Gy; prior radiation therapy (RT) must have been completed > 6 months prior to initiation of IMRT reirradiation; if previous RT records are unavailable, investigators can estimate the dose to previously treated tissues based on completion notes or other treatment history
56
Expected survival of ? 12 weeks.
57
Has been on any hormonal treatment (including progestin-containing intrauterine device [IUD]) for CAH/EIN or grade 1 endometrial carcinoma in last 3 months
58
Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy
59
Ascites that your doctor will manage by increasing your medications or by performing non-invasive methods (eg, paracentesis) to control, within 6 months prior to the first scheduled dose.
60
Life expectance of >= 3 months
61
Women taking estrogen containing contraceptives or Hormone Replacement Therapy (HRT) must discontinue the treatment a minimum of 6 months prior to the screening mammogram. Progestin only contraceptives are permitted.
62
Chronic bronchitis or emphysema requiring oxygen therapy within the last 6 months
63
History of gastrointestinal perforation and/or fistulae within 6 months prior to enrollment
64
Patient is pregnant or breastfeeding, or plans to become pregnant or father children from time of signing consent and lasting until 6 months after the last dose of trial treatment
65
Duration of prior HMA therapy ? 9 months and/or total ? 9 cycles of prior HMA therapy in ? 12 months
66
Last dose of AZA or DAC within 6 months before the planned date of randomization; however, must be off these treatments for ? 4 weeks before randomization
67
New onset seizures (within 3 months before planned randomization) or poorly controlled seizures
68
Failed prior alloSCT within the past 6 months from Cycle 1 Day 1
69
Platelets ? 100,000/microliter independent of transfusion and/or growth factors within 3 months prior to randomization
70
Patients with primary plasma cell leukemia in VGPR or better at the time of enrollment with no prior disease progression and within 18 months prior to initiation of anti-myeloma therapy which may include single or planned tandem autologous transplant .
71
Patients with prior history of a thromboembolic event within the last 12 months that is not being treated with systemic anticoagulation are excluded
72
Splenic irradiation within the last 6 months
73
History or evidence of thrombotic or hemorrhagic disorders within 6 months before first study treatment
74
Ongoing bowel perforation or presence of bowel fistula or abscess or history of small or large bowel obstruction within 3 months of registration, including subjects with palliative gastric drainage catheters. Subjects with palliative diverting ileostomy or colostomy are allowed if they have been symptom-free for more than 3 months.
75
PSA doubling time of < 6 months, measured over the 3 months prior to enrollment
76
Received PDT during the past 3 months
77
Prior treatment with clofarabine within 6 months or history of clofarabine-induced liver dysfunction
78
Previous androgen deprivation therapy lasting more than 6 months
79
alemtuzumab within 6 months of enrollment
80
fludarabine, cladribine, or clofarabine within 3 months of enrollment
81
Presence of active lymphoma or active PTLD, based on imaging performed within the previous 3 months.
82
Anticipated survival minimum of 12 months.
83
Prior regimen within 6 months
84
Prior regimen must be within 6 months of registration
85
Disease has progressed through at least one systemic therapy or through local irradiation within the preceding 6 months.
86
Prior Red blood cell (RBC) transfusion < 3 months prior to starting CC-90002.
87
Exposure to household contacts =< 15 months old or household contact with known immunodeficiency
88
Treatment with the modified Atkins diet (MAD) for any cause within the 9 months prior to study enrollment
89
Previous or concurrent treatment with selective estrogen receptor modulator (SERM) and/or hormonal replacement therapy within 3 months of the study
90
At least 3 months has elapsed from the time of transplant and
91
Patient is more than 6 months since the last dose of FOLFIRI
92
COHORT B, GROUP 6: HEPATOCELLULAR CARCINOMA: Ascites that is not medically controlled or that required a therapeutic paracentesis within last 3 months
93
COHORT B, GROUP 6: HEPATOCELLULAR CARCINOMA: Any episode of hepatic encephalopathy within the previous 6 months
94
Patients that have undergone treatment with anti-CTLA-4 (Cytotoxic T-Lymphocyte Antigen 4) antibody must have at least 3 months from last dose of CTLA-4 antibody before they can be enrolled into this study
95
Expected survival of at least 3 months.
96
unstable angina (anginal symptoms at rest) or new onset angina (i.e., began within the last 3 months).
97
Normal mammogram of unaffected breast within 12 months prior to study entry
98
All conditions associated with significant necrosis of nontumor-bearing tissues: esophageal or gastroduodenal ulcers < 6 months prior to enrollment, organ infarction < 6 months prior to enrollment, or active ischemic bowel disease
99
Any prior myeloablative transplant within the last 6 months
100
History or evidence of thrombotic disorders within 6 months before first study treatment unless stable on anticoagulation for > 3 months
101
> 1 hospital admission for infection in prior 6 months
102
Anticipated survival of < 3 months
103
Agree to be evaluated at the transplant center or by local provider every 3 months for 12 months after randomization
104
Presence of any other medical complication that implies survival of less than six months
105
Patients with Allo-SCT on active GVHD or immunosuppression therapy within 3 months prior to C1D1.
106
Started antiandrogen therapy (ADT) no longer than 6 months prior to randomization
107
Current use of statins or fibrates for any time during the 3 months prior to the study
108
Prior treatment with immunotherapy (e.g. ipilimumab, nivolumab, pembrolizumab, atezolizumab) within 6 months of cycle 1 day 1
109
Subjects with arterial thrombotic events in the prior 12 months (axitinib has never been studied in this population)
110
Subjects who have had venous thrombotic events in the prior 6 months (axitinib has never been studied in this population)
111
Men who intend to father children during the study or within 4 months afterward are excluded
112
Carboplatin or paclitaxel exposure within past 6 months.
113
History of coronary or vascular stent placed within the past 3 months (may be extended to 1 year if medically indicated per physician discretion).
114
Prior androgen deprivation therapy is allowed and may have been initiated up to 6 months prior to the date of the HDR implant; the complete duration of androgen deprivation therapy can range from 4 months to 36 months provided it has been initiated no more than 6 months prior to the date of the HDR implant
115
For known primary, disease-specific graded prognostic assessment (ds-GPA) estimated median survival no less than 6 months
116
For unknown primary, graded prognostic assessment (GPA) estimated median survival no less than 6 months
117
Patients who have a known primary and have an estimated median survival less than 6 months per ds-GPA
118
Patients who have an unknown primary and have an estimated median survival less than 6 months per GPA
119
Active malignancies (that is, requiring treatment change in the last 24 months) other than urothelial cancer (except skin cancers within the last 24 months that is considered completely cured)
120
Less than 6 months from the completion of last trastuzumab infusion
121
Biopsy taken from one or more tumors located above the ureteropelvic junction (UPJ) showing LG urothelial carcinoma. Diagnosed not more than 2 months prior to the screening.
122
Wash urine cytology sampled from the pyelocalyceal system documenting the absence of HG urothelial cancer, diagnosed not more than 2 months prior to the screening.
123
No recent (=< 3 months) of partial or complete bowel obstruction unless surgically corrected
124
Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis
125
Hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy
126
Age ? 55 years with no menses for 12 or more months without an alternative medical cause AND an FSH level > 40 IU/L; or
127
Last dose of anticancer therapy must have been administered within 6 months of the date of randomization into this study.
128
Prior intra-anal use of topical 5-fluorouracil 5% or imiquimod 2.5%, 3.75% or 5% for treatment of HSIL at any point, use of intra-anal or topical 5-fluorouracil 5% or imiquimod 2.5%, 3.75% or 5% for treatment of condyloma within 6 months prior to randomization or perianal imiquimod 2.5%, 3.75% or 5% or topical 5-fluorouracil 5% within 6 months prior to randomization
129
Radiation: patients must have:\r\n* Had their last fraction of local irradiation to primary tumor >= 12 months prior to registration; investigators are reminded to review potentially eligible cases to avoid confusion with pseudo-progression\r\n* Had their last fraction of craniospinal irradiation (> 24 Gy) > 3 months prior to registration
130
Radiotherapy to a target lesion within the past 3 months prior to baseline imaging unless that area has demonstrated progression
131
Patient History\r\n* No class III or IV congestive heart failure (CHF) within 6 months of registration\r\n* No clinically significant cardiac arrhythmia within 6 months of registration\r\n* No unstable angina or MI within 6 months of registration\r\n* No thromboembolic events within 6 months of registration (including [incl.] stroke, transient ischemic attack [TIA], deep vein thrombosis [DVT], & pulmonary embolism [PE])\r\n* No known history of congenital long QT syndrome\r\n* No uncontrolled hypertension within 14 days of registration (defined as systolic blood pressure [SBP] >= 150 mmHg and/or diastolic blood pressure [DBP] >= 90 mmHg despite optimal medical management)\r\n* No clinically significant GI bleeding within 6 months of registration\r\n* No clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding within 6 months of registration including, but not limited to: active peptic ulcer, known endoluminal metastatic lesion(s) with history of bleeding, inflammatory bowel disease, or other gastrointestinal conditions with increased risk of perforation\r\n* No GI perforation within 6 months of registration\r\n* No known tumor invading the GI tract within 28 days of registration\r\n* No radiologic or clinical evidence of pancreatitis\r\n* No known cavitary lung lesions\r\n* No known endobronchial lesions involving the main or lobar bronchi and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage; (CT with contrast is recommended to evaluate such lesions)\r\n* No hemoptysis greater than 1/2 teaspoon (2.5 mL) or any other signs of pulmonary hemorrhage within the 3 months prior to registration\r\n* No known tumor invading or encasing any major blood vessels\r\n* No history of non-healing wounds or ulcers within 28 days of registration\r\n* No history of fracture within 28 days of registration\r\n* No brain metastases or cranial epidural disease unless adequately treated, stable, and off steroid support for at least 4 weeks prior to registration\r\n* No known medical condition causing an inability to swallow oral formulations of agents\r\n* No history of allergic reaction attributed to compounds of similar chemical or biological composition to cabozantinib/placebo\r\n* No “currently active” second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ; patients are not considered to have a “currently active” malignancy if they have completed therapy and are free of disease for >= 3 years
132
Other malignancies requiring active treatment in the last 6 months
133
Completion of at least 3 months, but no more than 7 months of standard induction chemotherapy for LAPC, which should consist of either FOLFIRINOX or gemcitabine and nab-paclitaxel, preferably with a washout period no longer than 8 weeks.
134
Aged at least 2 months and less than 18-years-old on Day 1 AND
135
> 1 hospital admission for infection in prior 6 months
136
Anticipated survival of < 3 months
137
Have active disease, with at least 2 documented porphyria attacks within the last 6 months
138
Internal jugular venous thrombosis, acute or within 3 months.
139
Inclusion Criteria: All subjects\n\n          1. Histologically confirmed diagnosis of B-cell follicular lymphoma based on the WHO 2008\n             classification of tumors of hematopoietic and lymphoid tissue.\n\n          2. ?2 prior systemic treatments for follicular lymphoma.\n\n          3. Previously received an anti-CD20 antibody and an appropriate alkylator-based\n             combination therapy.\n\n          4. Disease progression within 12 months after completion of most recent therapy or\n             refractory disease.\n\n          5. Presence of measurable disease.\n\n          6. Availability of archival tissue confirming diagnosis.\n\n          7. ECOG performance status of 0,1 or 2.\n\n          8. Life expectancy ?6 months.\n\n          9. Adequate bone marrow function.\n\n         10. Adequate renal and hepatic function.\n\n         11. Females of childbearing potential and non-sterile males must agree to use highly\n             effective methods of birth control throughout the course of study and at least up to\n             90 days after last dosing, or 18 months after the last dose of obinutuzumab, whichever\n             is longer.\n\n         12. Male subjects are eligible if vasectomized or if they agree to the use of barrier\n             contraception in combination with other methods during the study treatment period and\n             for ? 90 days after the last dose of BGB-3111.\n\n         13. Ability to provide the written informed consent and can understand and comply with the\n             requirements of the study.\n\n        Exclusion Criteria: All subjects\n\n          1. Prior exposure to a BTK inhibitor.\n\n          2. Known central nervous system involvement by leukemia or lymphoma.\n\n          3. No evidence of transformation from follicular lymphoma to other aggressive histology.\n\n          4. No allogeneic hematopoietic stem cell transplantation within 12 months of enrollment\n\n          5. Prior malignancy within the past 5 years, except for basal or squamous cell skin\n             cancer, superficial bladder cancer, carcinoma in situ of the cervix of breast, or\n             localized Gleason score 6 prostate\n\n          6. Clinically significant cardiovascular disease.\n\n          7. Major surgery or significant injury ? 4 weeks prior to start of study treatment.\n\n          8. Active fungal, bacterial or viral infection requiring systemic treatment.\n\n          9. History of severe bleeding disorder.\n\n         10. History of stroke or intracranial hemorrhage within 6 months before first study drug.\n\n         11. Severe or debilitating pulmonary disease.\n\n         12. Known human immunodeficiency virus (HIV) or active hepatitis B or C.\n\n         13. Unable to swallow capsules or significant gastrointestinal disease that would\n             interfere with drug absorption.\n\n         14. Requires ongoing treatment with a strong CYP3A inhibitor or inducer\n\n         15. Pregnant or nursing females.\n\n         16. Vaccination with live vaccine within 35 days prior to first dose.\n\n         17. Ongoing drug or alcohol addiction.\n\n         18. Hypersensitivity to BGB-3111, known ingredients of BGB-3111 or obinutuzumab.\n\n         19. Participation in another therapeutic trial.
140
Expected survival > 3 months from study enrollment
141
Have expected survival of at least 4 months
142
Life expectancy of > 12 months (exclusive of the disease for which the auto HSCT is being performed)
143
History of acute urinary retention within 6 months of study entry;
144
Clinical symptoms (e.g., dyspnea or cough) consistent with BOS of ? 2 months duration
145
Patients must have life-expectancies > 6 months to be included in the trial
146
A woman who is pregnant or breast-feeding, or a woman who is planning to become pregnant or a man who plans to father a child while enrolled in this study or within 3 months after the last dose of study agent
147
History or evidence of central nervous system bleeding as defined by stroke or intraocular bleed (including embolic stroke) not associated with any antitumor surgery within 6 months before enrolment
148
Expected survival ? 3 months
149
T cell-directed antibody therapy (eg. Alemtuzumab, anti-thymocyte globulin) within 6 months of enrollment
150
Experienced at least 1 VOC within the preceding 12 months prior to Screening, as determined by medical history.
151
If receiving HU/HC or erythropoietin stimulating agent, must have been receiving the drug for at least 6 months prior to Screening
152
Subjects must have progression within 6 months of platin exposure during definitive or palliative therapy.
153
Subjects willing to participate in the study for at least 8 months
154
Cerebrovascular accident (CVA) with persistent neurologic deficits occurring within 6 months prior to enrollment; persisting neurologic deficits from a CVA occurring over 6 months prior to enrollment are not necessarily grounds for exclusion
155
>= grade 3 thromboembolic event in the last 6 months
156
Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least 6 months with a stable dose for at least the last three months of therapy
157
Estimated survival >= 3 months
158
Documented history of capillary leak syndrome within 6 months of study enrollment.
159
Expected survival must be greater than three months
160
Participants with a serious medical illness that may limit survival to less than 3 months
161
Must have had a diagnostic mammogram performed within the last 6 months
162
Expected survival > 6 months
163
Myocardial infraction (MI) within the previous 6 months
164
Participants with a history of variceal bleed within 6 months prior to enrollment
165
Evidence of serious suicide risk including any history of suicidal behavior in the last 6 months and/or any suicidal ideation in the last 2 months and/or poses a significant suicide risk in the judgment of the investigator
166
Syncopal episode within 12 months of screening
167
Pulmonary embolism (PE) in the 3 months before enrollment; anticoagulation is permitted as long as stable dosage for more than 3 months
168
alemtuzumab within 6 months of enrollment
169
fludarabine, cladribine, or clofarabine within 3 months of enrollment
170
Life expectancy < 6 months (as estimated per diagnosis-specific graded prognostic assessment [ds-GPA])
171
The diagnosis of relapsed FL must have been made within the last 6 months of screening if no other treatment is given for the FL in the interim; if an interim treatment is given within the last 6 month, re-biopsy will be required even if there is already a biopsy proven relapsed FL within the last 6 months
172
History of any arterial thromboembolic event within 3 months prior to first dose of investigational product
173
Must have medical assessment consistent with prognosis for an expected survival of at least 6 months and be clinically appropriate to receive a 12 week hiatus from any cytotoxic treatment according to the best clinical judgement of the treating investigator.
174
Has history of wound dehiscence or complications requiring medical intervention within 6 months of study entry
175
Acute myeloblastic leukemia (AML) that was previously treated with HMA and is unfit for intensive chemotherapy\r\n* Patient must be within 6 months of prior treatment with HMA and must be willing to be treated with the same agent on this study
176
Exposure to household contacts =< 15 months old or household contact with known immunodeficiency
177
Patient must have BCG unresponsive non-muscle-invasive bladder cancer defined as: Persistent or recurrence of carcinoma in situ (CIS) within 12 months, or recurrence of CIS with Ta/T1 papillary disease within 12 months, or recurrence of high grade Ta or T1 papillary disease alone within 6 months of receiving at least two courses of intravesical BCG (at least five of six induction doses and at least two doses of either a maintenance course of BCG or a 2nd re-induction of BCG; or T1 high-grade disease at the first evaluation following induction of BCG alone (at least five of six induction doses)
178
History or evidence of thrombotic or hemorrhagic disorders within 6 months before first study treatment
179
Patients must have completed at least 2 months of their current endocrine therapy prior to registration
180
Any episode of atrial fibrillation in the prior 12 months.
181
Previously received GnRH analog or other form of androgen deprivation therapy (estrogen or antiandrogen) for > 18 months total duration. If androgen deprivation therapy was received for ? 18 months total duration, then that therapy must have been completed at least 3 months prior to baseline. If the dosing interval of the depot is longer than 3 months, then the prior androgen deprivation therapy must have been completed at least as long as the dosing interval of the depot;
182
Previous intravesical therapy within 6 months of study entry.
183
Myocardial Infraction (MI) within the previous 6 months
184
Female subject is pregnant or breast-feeding, or planning to become pregnant or male subject is planning to father a child within the projected duration of the trial, starting with the pre-screening or screening visit, during study treatment and through 3 months after the last dose of talimogene laherparepvec or 4 months after the last dose of pembrolizumab, whichever is later
185
Age ? 55 years with no menses for 12 or more months without an alternative medical cause AND an FSH level > 40 IU/L; or
186
Have expected survival of at least 4 months
187
No known Food and Drug Administration (FDA) -approved therapy available that is expected to prolong survival by greater than 3 months
188
>= 2 months since last therapy for HSIL
189
PSA doubling time (PSADT) =< 6 months, based upon >= 3 consecutive measurements collected in the past 12 months, at least 4 weeks apart, calculating using the Memorial Sloan-Kettering Cancer Center (MSKCC) calculator
190
Prior androgen deprivation therapy (ADT) in the past 6 months; prior ADT in context of neoadjuvant/adjuvant primary; prior ADT for biochemical recurrence is allowed, as long as no ADT has been administered in past 6 months and testosterone has recovered (> 150 ng/dl); the total duration of prior ADT should not exceed 24 months
191
Participants have had at least 1 episode of vaso-occlusive crisis (VOC) in the past 12 months.
192
For participants taking hydroxyurea (HU), the dose of HU (mg/kg) must be stable for at least 3 months prior to signing the ICF.
193
More than 10 VOCs within the past 12 months that required a hospital, emergency room or clinic visit
194
Patients with life expectancy of =< 6 months for reasons other than their underlying hematologic/oncologic disorder
195
All patients must have radiographic evidence of progression at a spinal site previously irradiated greater than 6 months prior to randomization; this includes indirect radiation exposure to spinal site
196
Anticipated survival of at least 3 months
197
Expected survival < 2 months
198
Treatment with alemtuzumab within 6 months of leukapheresis or fludarabine or cladribine within 3 months of leukapheresis
199
Subject with extensive pelvic mass at risk of fistulization, or history of bowel obstruction within 3 months prior to the proposed first dose of study treatment
200
requirement for intravenous alimentation active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia, or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy.
201
Inclusion Criteria:\n\n        For both portions of the study, participants must satisfy all of the following inclusion\n        criteria to be enrolled in the study:\n\n          -  Written Institutional Review Board/Ethics Committee-approved informed consent form\n             (ICF), signed by participant or legally authorized representative.\n\n          -  Participants must be determined to have histologically confirmed unresectable, locally\n             advanced or metastatic adenocarcinoma of the intra- and/or extra-hepatic bile ducts\n             and/or gallbladder. Participants must have sufficient tissue with architectural\n             integrity, including tumor and associated stroma, available for retrospective\n             biomarker testing.\n\n          -  One or more lesions measurable on computed tomography (CT) scan/magnetic resonance\n             imaging (MRI) scan per Response Evaluation Criteria in Solid Tumors (RECIST) version\n             1.1 (v1.1).\n\n          -  Participants having Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\n             to 1.\n\n          -  Life expectancy ?3 months.\n\n          -  Males and females aged ?18 years.\n\n          -  Screening clinical laboratory values within pre-determined parameters\n\n          -  Female participants of childbearing potential (WOCBP) must have a negative urine or\n             serum pregnancy test within 7 days before Day 1 (first dose of study medication).\n\n          -  For WOCBP and for men, agreement to use a highly effective contraceptive method from\n             the time of screening throughout the study until 5 months (WOCBP) or 6 months (men)\n             after administration of the last dose of any study medication. Highly effective\n             contraceptive methods consist of prior sterilization, intrauterine device (IUD),\n             intrauterine hormone releasing system (IUS), oral or injectable contraceptives,\n             barrier methods, and/or true sexual abstinence.\n\n        Exclusion Criteria:\n\n        Participants are ineligible for enrollment if they meet any of the following exclusion\n        criteria:\n\n          -  Clinical evidence of deep vein thrombosis or pulmonary embolism present during the\n             screening period\n\n          -  New York Heart Association Class III or IV cardiac disease, atrial fibrillation,\n             unstable angina, or myocardial infarction within the past 12 months before screening.\n\n          -  Participants with known brain metastases\n\n          -  History of cerebrovascular accident or transient ischemic attack\n\n          -  History of active bleeding within the last 3 months prior to screening requiring\n             transfusion.\n\n          -  Participants must have received no previous radiotherapy, surgery, chemotherapy or\n             investigational therapy for treatment of metastatic or locally advanced disease.\n\n          -  Active hepatitis B virus (HBV) infection, defined as having a positive hepatitis B\n             surface antigen (HBsAg) test at screening\n\n          -  Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody\n             test at screening\n\n          -  History of:\n\n               1. Idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis\n                  obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of\n                  active pneumonitis on screening chest CT scan. History of radiation pneumonitis\n                  in the radiation field (fibrosis) is permitted.\n\n               2. Or known cases of hepatobiliary diseases (e.g., primary biliary cholangitis,\n                  primary sclerosing cholangitis, history of immune-mediated cholangitis);\n\n                  Participants with cholangitis attributed to infectious etiology (e.g., ascending\n                  cholangitis, bacterial cholangitis) are eligible if the infection has been fully\n                  resolved prior to the screening visit.\n\n               3. Or known cases of drug-induced hepatobiliary toxicities.\n\n          -  Active or history of autoimmune diseases\n\n          -  Uncontrolled hypercalcemia
202
active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy;
203
Subject has an ECOG Performance Status 0-1 and anticipated life expectancy >6 months prior to apheresis and >3 months prior to lymphodepletion.
204
Current thrombotic or hemorrhagic disorder/event or history of prior event within 6 months of start of screening
205
Baseline skin biopsy taken within 6 months available for central review submission
206
GNRH agonists or GNRH antagonists (e.g., leuprorelin, degarelix) for > 2 months prior to consenting
207
Estrogen containing compounds for > 2 months prior to enrollment
208
Prior allo-HCT less than three months from the time of enrollment
209
Documented fungal infection within 3 months of BMT
210
History of syncope within the last 6 months
211
Previous stroke < 12 months
212
Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product
213
No active alcohol addiction (as assessed by medical caregiver and defined as at least 6 months without activity)
214
If currently receiving erythroid stimulating agents (ESA) with plans to continue during study, less than 2 months duration of therapy with ESA prior to screening or dose escalation performed within 2 months of screening or addition of granulocyte colony stimulating factor (GCSF) to ESA within 2 months of screening
215
Has had esophageal or gastric variceal bleeding within the last 6 months; all subjects will be screened for esophageal varices, unless such screening has been performed in the past 12 months before first dose of treatment; if varices are present, they should be treated according to institutional standards before starting study treatment
216
Has had encephalopathy in the last 6 months; subjects on rifaximin or lactulose to control their encephalopathy are not allowed
217
Must have pathologically confirmed urothelial carcinoma in situ (CIS) of the bladder and meet one of the following criteria\r\n* Persistence of high-grade CIS at 6 months following an adequate course of BCG; OR\r\n* Stage/grade progression at 3 months after induction BCG; OR\r\n* Recurrence of high-grade CIS after achieving a disease-free state (i.e., complete response [CR]) following induction of an adequate course of BCG that occurs < 9 months after the last exposure to BCG; OR\r\n* Persistent CIS noted on the bladder biopsies within 3 months of completing at least 2 induction BCG (minimum of five weekly instillations)\r\nAn adequate course of BCG should be defined as at least one course of induction (minimum of five weekly instillations) and one maintenance (two of three instillations) in a 6 months period, with an exception for any patient with grade/stage progression after induction BCG (minimum of five weekly instillations)
218
Expected survival of at least 3 years
219
Predicted survival of > 6 months
220
Previous extensive radiotherapy to the lung or liver during the last 4 months prior to lymphodepletion regimen.
221
Completion of at least 3 months, but no more than 12 months of standard induction chemotherapy for LAPC, which may include FOLFIRINOX or gemcitabine and nab-paclitaxel, preferably within 2-4 weeks but no longer than 8 weeks
222
Previous radiotherapy within 3 months before study entry
223
No treatment with paclitaxel or nab-paclitaxel within 4 months prior to initiation of study therapy
224
Treatment with alemtuzumab or other T cell-depleting antibodies within 6 months of T cell therapy
225
Platelet count of >= 100 k/mL independent of transfusion and/or growth factors within 3 months prior to randomization
226
History of central nervous system bleeding as defined by stroke or intraocular bleed within 6 months of enrollment.
227
Taxane therapy within the past 3 months (90 days) prior to study day 1
228
New onset seizures (within 3 months prior to screening) or poorly controlled seizures
229
Prior pancreatitis that was symptomatic or required medical intervention =< 6 months prior to registration (known toxicity of pembrolizumab)
230
Prior enteritis that was symptomatic or required medical intervention =< 6 months prior to registration (known toxicity of pembrolizumab)
231
Uncontrolled hyper/hypothyroidism or hyper/hypocorticism =< 6 months prior to registration (known toxicity of pembrolizumab)
232
Patients with hemoptysis (defined as bright red blood or >= 1/2 teaspoon) within 2 months prior to enrollment, or with central or cavitating lesions, will be excluded
233
The patient has a history of GI perforation and/or fistulae within 6 months prior to enrollment
234
Less than 3 months since prior myeloablative transplant
235
Have failed prior treatment within 6 months of consent date
236
Prior conventional irradiation of the spine site and level to be treated with an interval shorter than 3 months
237
Expected survival ? 6 months.
238
History of arterial thrombosis within 3 months of starting study treatment
239
Patients treated with any Cyp17-lyase inhibitor, any 2nd generation AR antagonist (e.g. enzalutamide), cabazitaxel or carboplatin whose disease progressed while on treatment or within 3 months of its discontinuation; patients who have received any of these treatments more than 12 months from study entry and whose disease did not progress while on treatment or within 3 months of its discontinuation are allowed on study
240
Patients will be required to have received prior treatment with azithromycin for at least 3 months prior to enrollment, unless there is evidence of progression or unsatisfactory response while on azithromycin prior to 3 months of treatment, as deemed by the treating or referring physician; patients who are on azithromycin will need to discontinue for at least 2 weeks prior to enrollment
241
Must be >= 3 months after prior myeloablative transplant, if applicable
242
No available curative treatment options, a limited prognosis of several months to < 2 years anticipated survival with currently available therapies, and progressive or relapsed disease
243
May have had up to 24 months of ADT (testosterone suppression therapy) in the nonmetastatic setting and are at least 12 months removed from treatment
244
Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months)
245
Expected survival must be greater than 3 months
246
Receipt of sunitinib within 3 months of receiving tremelimumab
247
History of arterial thromboembolic events in the past 3 months and of venous thromboembolic events in the past month
248
Patient and partner are willing to use condoms for 12 months after receiving Toca 511 or until there is no evidence of the virus in his/her blood, whichever is longer.
249
Patients with life expectancy of =< 6 months for reasons other than their underlying hematologic/oncologic disorder
250
Expected survival of more than 12 weeks;
251
For hypomethylating failure cohorts only, more than 4 months since last cycle of HMA
252
Previous history of haemoptysis (expectoration of more than 2.5 mL of blood), within three months prior to enrollment
253
Arterial or venous thromboembolic events within 6 months of study enrollment
254
Within 3 months of registration: Serum potassium >= 3.5 mmol/L
255
That has progressed within 6 months prior to study enrollment (Cohort 5 Expansion and Cohort 6 ONLY)
256
Vaccinations initiated between 3 weeks and 3 months from completion of SoC multi-modality cancer care
257
Disease-free interval =< 30 months
258
Patients with an estimated survival of less than three months.
259
Expected survival > 3 months
260
Prior GEM therapy is acceptable as long as the last dose was >= 3 months from registration on this study
261
Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting study drugs
262
Male patients must agree not to donate sperm during the study and for 2 months after discontinuation of vismodegib
263
Cumulative activity of 131 iodine greater than 400 millicuries (mCi) or 14.8 gigabecquerels (GBq), with the last dose administered at least 6 months prior to study entry.
264
History of peptic ulcer disease or erosive gastritis within the past 3 months, unless treated for the condition and complete resolution has been documented by esophagogastroduodenoscopy (EGD) within 28 days of starting study treatment
265
Recent documented myocarditis within 2 months of consent
266
Trastuzumab treatment within the last 3 months
267
Postmenopausal with last natural menses > 24 months prior
268
Has a history of an arterial thromboembolic event within the prior six months including CVA, TIA, MI, or unstable angina
269
Syncopal episode within 12 months of screening
270
History of HIV-associated encephalopathy; dementia of any kind; seizures in the past 12 months
271
Anticipated survival of at least 6 months
272
Radiotherapy to the target lesion within the past 3 months prior to baseline imaging
273
Patients with a life expectancy of < 6 months as predicted by the Adult Comorbidity Index (ACE-27)
274
Current enrollment or plans to enroll in another smoking cessation program in the next 12 months
275
Serious or unstable disease within the past 3 months
276
History (last 3 months) of abnormal heart rhythms, cardiovascular disease (stroke, angina, heart attack) may result in ineligibility; these conditions will be evaluated on a case by case basis by the study physician
277
Patient with stroke in the last 3 months
278
Patients with a history of seizures with in the past 3 months
279
Must have an expected survival status of at least 3 months
280
Patients with another active malignancy; asymptomatic sites of disease are not considered active; treated or untreated sites of disease may be considered inactive if they are stable for at least 2 months and are not expected to require therapy for 4 months
281
Had eculizumab therapy within three months prior to screening
282
Syncopal episode within 12 months of screening
283
History or signs of active coronary artery disease with angina pectoris within the last 6 months.
284
COHORT II: At the time of enrollment, patients must have had bilateral mammograms within 6 months
285
Expected survival > 3 months
286
Prior radiotherapy to doses >= 45 Gy to the area of recurrence, >= 6 months prior to enrollment
287
Females are either postmenopausal for at least 1 year, are surgically sterile for at least 3 months, or must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through 12 months after the last dose of rituximab if of childbearing potential; (Note: permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed)
288
An interval of >= 2 months since completion of fractionated radiotherapy
289
Cytarabine containing regimen in excess of 2 g/m^2/day within 6 months of study entry
290
Prior autologous SCT in last 12 months
291
Patients must not have nor had active or recent peptic ulcer disease within the past 6 months\r\n* Patients with active significant symptoms of dyspepsia will be excluded
292
Exposure to household contacts =< 15 months old or household contact with known immunodeficiency
293
Patients ineligible if the time interval between radical prostatectomy and the first day of randomization exceeds 3 months (+/- 2 weeks)
294
Treatment with androgens within 6 months prior to study enrollment
295
Patients who have met the above criteria and who have undergone CRS and HIPEC in the past 18 months for the forementioned disease processes without evidence of recurrence will be eligible for participation in this study for analyzing ability to achieve complete cytoreduction, morbidity, progression and survival
296
Expected survival > 12 weeks
297
Patients must have evidence of disease progression as demonstrated by an increase of > 50% in lymphocytosis since diagnosis and/or lymphadenopathy and a lymphocyte doubling time of more than 6 months; patients must have had at least 3 months of observation since diagnosis
298
Cardiac ejection fraction (EF) >= 45% by 2-dimensional echocardiogram (2D-ECHO) within 3 months of study entry (or within 1 month if received chemotherapy within the past 3 months)
299
Previous hospitalization due to documented heart failure in the last 12 months
300
Expected survival > 2 months
301
Patients registering to Arms D, E, F, G, H, I, X, Y must not currently be smoking tobacco or other substances and must not have smoked within the past 6 months
302
Relapsed/refractory MCL: The patient has a prior or concurrent malignancy that in the opinion of the investigator, presents a greater risk to the patient’s health and survival, than of the MCL, within the subsequent 6 months at the time of consent
303
Prior exposure to thiazolidinedione (TZD) therapy in the past 12 months
304
No prior allogeneic HCT, and no autologous HCT within the previous 12 months
305
Estimated survival of at least 3 months
306
Male sterilization (at least 6 months prior to screening). For female subjects on the study the vasectomized male partner should be the sole partner for that subject.
307
History of treatment with canakinumab within the 12 months prior to study initiation
308
Unstable angina pectoris < 6 months prior to screening
309
Acute symptomatic pancreatitis within 6 months of study entry or a diagnosis of chronic pancreatitis at the time of randomization.
310
Expected survival > 3 months
311
Patients with life expectancy of =< 6 months for reasons other than their underlying hematologic/oncologic disorder
312
Patients must have received the current TKI for at least 18 months and not have increased their dose in the last 6 months.
313
An anticipated overall survival of at least 6 months
314
Prior exposure to CMC-544 within past 6 months
315
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Use of systemic antibiotics in 12 months preceding baseline sampling
316
Prior allogeneic hematopoietic SCT within the last 12 months or reduced-intensity transplant within the past 6 months
317
Anticipated patient survival under 3 months
318
Documented cerebral infarction within past 12 months
319
At least 2 months from completion of temozolomide (to be consistent with the “rechallenge” group from Perry et al. JCO 2010)
320
A prior history of Gliadel implantation in the past six months
321
Patients are eligible to start on this protocol if they are between 6 months to 10 months post transplant
322
Life expectancy of greater than 2 months to allow completion of study treatment and assessment of dose-limiting toxicity
323
Subjects who are in first relapse after initial induction, if they had a response duration of >12 months from date when first response first documented or if they are good candidates for HCT.
324
Unstable angina within 6 months prior to first dose;
325
For female patients of childbearing potential (i.e., have had a menstrual period within the past 12 months): unwilling or unable to undergo hormonal suppression to avoid menstruation during treatment.
326
Recent (< 12 months) active diverticulitis
327
Male sterilization (at least 6 months prior to Screening). For female patients on the study the vasectomized male partner should be the sole partner for that patient
328
Patients with life expectancy of =< 6 months for reasons other than their underlying hematologic/oncologic disorder
329
Patients with life expectancy of =< 6 months for reasons other than their underlying hematologic/oncologic disorder
330
One of the following, in order to lower risk of graft rejection: cytotoxic chemotherapy, an adequate course of 5-azacitidine or decitabine, or alemtuzumab within 3 months prior to start of conditioning; or previous BMT within 6 months prior to start of conditioning; Note: patients who have received treatment outside of these windows may be eligible if it is deemed sufficient to reduce graft rejection risk; this will be decided on a case-by-case basis by the Principal Investigator (PI) or co-PI
331
No other therapy (i.e. chemotherapy, interferon) for 4 weeks prior to study entry, or cladribine for 6 months prior to study entry, unless progressive disease more than 2 months after cladribine is documented
332
25(OH) D3 level less than 40 ng/ml within 3 months of initiation of study; most recent 25 hydroxy D level within last 3 months would be used
333
Patients should not have severe, active co-morbidity that would preclude vertebroplasty or stereotactic radiotherapy, defined as follows:\r\n* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months\r\n* Transmural myocardial infarction within the last 6 months\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\r\n* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
334
Patients who have received >= 2 cycles of multiagent chemotherapy within the 3 months previous to UCBT; patients who have had previous autologous transplant within 12 months of UCBT are excluded regardless of history of recent treatment
335
MLL rearranged AND age > 6 months
336
MLL rearranged AND age < 6 months AND WBC < 300 x 10^9/L AND prednisone good response
337
Age at diagnosis < 6 months (i.e., < 183 days)
338
Myeloablative transplant within the last 6 months
339
If > 18 years old, prior myeloablative transplant within the last 6 months
340
Patients who have undergone an autologous transplant > 12 months prior to allogeneic transplantation and who have not received multi-agent or immunosuppressive chemotherapy within the preceding 3 months must receive anti-thymocyte globulin (ATG) as part of the preparative regimen
341
Second BMT: must be >= 3 months after prior myeloablative transplant
342
Transfusion dependent anemia with transfusion dependency of ?3 months
343
Active malignancies (that is, requiring treatment change in the last 24 months) other than urothelial cancer (except skin cancers within the last 24 months that are considered completely cured)
344
Able and willing to use double barrier method of contraception for at least 3 months prior to ST-400 infusion and through 6 months post-transplant
345
Bleeding or thrombotic disorder or any prescribed anticoagulant requiring therapeutic international normalized ratio monitoring (eg, warfarin or similar agents) at Screening, or within 6 months before randomization/enrollment
346
History of at least one documented blood transfusion within 6 months of enrollment
347
Chronic ITP (ITP lasting for greator than or equal to ([>=] 12 months) as defined in the protocol
348
Unstable angina within 6 months prior to study entry
349
Clinically stable in NYHA class 2 or 3 for the 3 months preceding screening
350
Use of GSK2315698 (CPHPC), or participation in a separate clinical trial involving CPHPC within 3 months of screening
351
Patients must have a reasonable expectation of ? 6 months survival
352
Sexually active males unless they use a condom during intercourse while taking drug and for 3 months after stopping ceritinib and should not father a child for at least 3 months after the last dose of treatment.
353
Prior focal radiotherapy within 3 months of screening.
354
Expected survival ? 6 months.
355
A serious, unstable illness, as judged by the Investigator, during the past 3 months before screening/baseline visit including but not limited to: hepatic, renal, gastro-enterologic, respiratory, cardiovascular, endocrinologic, neurologic or immunologic disease;
356
Male sterilization (at least 6 months prior to enrolling). For female patients on the study the vasectomized male partner should be the sole partner for that patient.
357
Expected survival > 6 months.
358
Patients with history of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae are NOT eligible for the study
359
Colonoscopy(or CT colonogram(within 16 months prior to randomization)
360
Having plans to leave the immediate geographical area within 9 months.
361
Participants must be currently participating in a PCI-32765 clinical study considered completed and have received at least 6 months of treatment with PCI-32765.
362
History of chronic steroid use within the past 6 months
363
Pelvic radiotherapy administered within less than 6 months prior to enrollment. Subjects who received radiotherapy ?6 months prior to enrollment must demonstrate no cystoscopic evidence or symptoms of radiation cystitis.
364
Previous intravesical immunotherapy less than 3 months before study entry; Note: if a patient is eligible for the study but has had intravesical immunotherapy within the past 3 months, they can enroll in the study and initiation of treatment of the drug will be delayed until a minimum of 90 days has passed since the previous treatment
365
Currently taking ibrutinib and first took ibrutinib > 3 months ago
366
Estimated survival ? 6 months.
367
Fludarabine based therapy within 6 months of enrollment
368
Expected survival ? 6 months
369
Has received allogeneic hematopoietic cell transplantation (HSCT) within 3 months of planned infusion of genetically modified T cells; HSCT >= 3 months from CAR-T cell infusion eligible.
370
Prior treatment with therapeutic dose of radioactive iodine (> 50 mCi) with evidence of RAI uptake on delayed scan, with progression within 12 months of RAI
371
Recent arterial thromboembolic event within the previous 6 months
372
Platelets ? 100,000/microliter without transfusion and/or growth factors in the 3 months prior to randomization
373
Expected survival ? 3 months in the view of the PI or investigators
374
Expected survival of greater than 16 weeks.
375
Presence of ascites that is not medically controlled or that required a therapeutic paracentesis within the last 3 months prior to initiation of study therapy
376
Hepatocellular carcinoma cohort specific exclusion criteria:\r\n* A history of hepatic encephalopathy within the past 12 months; patients on stable doses of lactulose for prophylaxis or as a result of previous hepatic encephalopathy (more than 12 months ago) are allowed (for HCC cohort only)\r\n* A history of bleeding esophageal or gastric varices within the last 6 months prior to initiation of study therapy
377
The patient has a prior or concurrent malignancy that in the opinion of the investigator, presents a greater risk to the patient’s health and survival, than of the MCL, within the subsequent 6 months at the time of consent.
378
Subject is a woman who is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 4 months after the last dose of any component of the treatment regimen. Or, subject is a man who plans to father a child while enrolled in this study or within 4 months after the last dose of any component of the treatment regimen
379
Documented myocarditis within 2 months of enrollment
380
Trastuzumab treatment within the last 3 months
381
Anticipated survival of at least 3 months
382
May not have prior malignancies unless the expected survival is at least 2 years
383
History of cardiovascular disease (e.g., myocardial infraction [MI], thrombotic or thromboembolic event in the last 6 months)
384
Patient had last menstrual period within the last 12 months or
385
Group 3 - patients must have pathologically documented, definitively diagnosed advanced MTC that has progressed within 14 months prior to the Screening Visit.
386
PRRT administered within 6 months of the first dose.
387
Patients with TE event occurring > 6 months prior to enrollment and receiving active anticoagulation
388
Active intravenous (IV) bisphosphonate use in the last 3 months
389
Patients for whom anthracycline, paclitaxel or antibody therapies are contraindicated: \r\n* Hypersensitivity reactions to any of the medications or to humanized monoclonal antibodies \r\n* History of congestive heart failure \r\n* Myocardial infarction within the past 12 months \r\n* Pre-existing peripheral neuropathy >= grade 2 \r\n* Prior anthracycline therapy with >= cumulative dose of 240 mg/m^2
390
Current exposure to household contacts =< 15 months old or household contact with known immunodeficiency
391
Willing to avoid household contacts =< 15 months old or household contact with known immunodeficiency 1 week after treatment
392
Exposure to household contacts =< 15 months old or household contact with a person with known immunodeficiency
393
Previous treatment with tocilizumab or other cytokine-targeted biologic disease modifying antirheumatic drugs (including adalimumab, certolizumab, etanercept, golimumab, infliximab, anakinra) within 3 months of enrollment
394
Subjects must not have had prior androgen deprivation therapy in the past 6 months
395
History of androgen deprivation therapy within the past 6 months
396
Expected survival >= 3 months
397
Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting study drugs
398
Stable, continuous antiretroviral treatment for at least three months before enrollment, defined as a multi-drug regimen (excluding azidothymidine [AZT])
399
New onset seizures (within 3 months prior to the first dose of rigosertib) or poorly controlled seizures.
400
History of thromboembolic episodes =< 3 months prior to registration
401
Exposure to household contacts =< 15 months old or household contact with known immunodeficiency
402
Patients with prior progressive disease who do not meet criteria above, are eligible as long as they have not been off treatment for > 3 months prior to enrollment on NANT 2011-04
403
Expected survival > 3months
404
Be postmenopausal (defined as amenorrheic for at least 12 months)
405
Active central nervous system (CNS) lymphoma, history of HIV-associated encephalopathy; dementia of any kind; seizures in the past 12 months; patients with a history of positive cerebrospinal fluid cytology that has become negative with intrathecal chemotherapy and the patient has been in remission for at least 12 months are eligible
406
Anticipated patient survival under 3 months
407
Must be >= 3 months after prior myeloablative transplant, if applicable
408
If the patient is determined to be cirrhotic (based on criteria outlined earlier), the patient must have an ultrasound done within 6 months prior to enrollment with no evidence of hepatocellular carcinoma
409
Transplant < 4 months prior to study enrollment
410
Any history of HIV-associated encephalopathy; dementia of any kind; seizures in the past 12 months
411
Angina pectoris =< 12 months prior to starting drug
412
Participants must be hepatitis C negative =< 6 months prior to screening
413
Expected survival > 3 months
414
Patients must have a complete cytogenetic response (CCyR) OR must have been on nilotinib for a minimum of six months
415
History of acute pancreatitis within 12 months prior to screening
416
Receiving mitotane within 6 months of enrolling on the study
417
Tamoxifen or other preventive measures within 6 months
418
History of cerebro-vascular accident within 6 months of enrollment
419
If there was a total or partial thyroidectomy completed within 3 months of enrollment, the surgical specimen must show the area of anaplastic thyroid cancer to be at least 1 cm in greatest dimension
420
Expected survival < 2 months
421
Never treated with cytoreductive drugs except hydroxyurea for up to 3 months maximum (phlebotomy, aspirin allowed, anagrelide allowed)
422
At the time of tumor recurrence, patients with CIS alone or high-grade Ta/T1 with CIS should be within 12 months of last exposure to BCG and patients with Ta/T1 without CIS should be within 6 months of last exposure to BCG
423
Pretransplant treatment with sorafenib tosylate (sorafenib) not > 12 months (not exceeding 12 months of treatment, total)
424
Subject must be at least 2 months (from first dose of lenalidomide) from stem cell infusion.
425
Cohort 2: Subjects with CIS with or without associated papillary disease whose disease is determined to be refractory or relapsed more than 6 months but within 11 months of the last dose of adequate BCG treatment.
426
Cohort 3: Subjects with high-grade Ta or any grade T1 papillary disease (without CIS) whose disease is determined to be refractory or relapsed within 6 months of the last dose of adequate BCG treatment. For eligibility and cohort assignment, 6 months is defined as 30 weeks i.e., 26 weeks (6 months) plus an additional 4 weeks to accommodate scheduling variations and for diagnostic work-up and 11 months is defined as 50 weeks i.e., 48 weeks (11 months) plus an additional 2 weeks to accommodate scheduling variations and for diagnostic work-up. For subjects enrolling in Cohort 2: The investigator documents he/she would not treat the subject with additional BCG at the time of study entry.
427
Disease progression during or after the last treatment regimen and within 6 months before study entry.
428
Participation in a clinical trial using immunological experimental therapy (e.g. monoclonal antibodies, cytokines or active cellular immunotherapies) within the last 6 months prior to randomization
429
Females must abstain from breastfeeding during study participation and 3 months after IP discontinuation.
430
For Cohort A: Has experienced a seizure or seizures within 6 months of study start or is currently being treated with cytochrome P450 enzyme (CYP) inducing anti-epileptic drugs for seizures
431
Previous anti-angiogenics or anti-vascular endothelial growth factor within 12 months of registration
432
Patient must have expected survival of ?3 months
433
Any BM relapse after allogeneic SCT and must be > 6 months from SCT at the time of CTL019 infusion OR
434
Male sterilization (at least 6 months prior to screening). For female patients on the study the vasectomized male partner should be the sole partner for that patient
435
Have experienced a Grade ?3 bleeding event within 3 months (?3 months) prior to randomization.
436
Life expectance of greater than two months to allow completion of study treatment and assessment of dose-limiting toxicity
437
Prior hormonal therapy. Neoadjuvant/adjuvant therapy to treat prostate cancer ? 36 months in duration and ? 9 months before randomization, or a single dose or a short course (? 6 months) of hormonal therapy given for rising PSA ? 9 months before randomization is allowed.;
438
At least 6 months since prior treatment with curative intent and recurrence
439
Splenic irradiation within 12 months prior to screening, or prior splenectomy.
440
< 6 months between completion of prior RT and initiation of reirradiation using proton therapy
441
History of intracranial abscess within 6 months prior to study enrolment.
442
Documented clinical prostatitis requiring therapy within 6 months prior to Treatment
443
History of acute urinary retention within the last 12 months
444
Patient must have progressed following 12 months of treatment with MEDI4736; patients who discontinue MEDI4736 prior to the completion of 12 months (for any reason) are not eligible; patients who have already completed two 12-month periods of treatment are not eligible
445
History of hemoptysis of ? 2.5 mL/1 teaspoon within 6 months of Cycle 1 Day 1
446
Active bowel obstruction, or hospitalization for bowel obstruction within 2 months prior to screening
447
Diagnosis of malignant disease within the previous 12 months
448
Active GI bleeding, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy
449
Other investigational mAbs within 6 months prior to first dose of IP.
450
History of clinically significant hemorrhagic or thrombotic event within the past 6 months, not including uncomplicated catheter-associated venous thrombosis; patients on anti-coagulation are not permitted to be on any oral formulations (warfarin, rivaroxaban, dabigatran, etc.) due to concern for drug-drug interaction
451
At least 2 months must have elapsed from the use of tamoxifen
452
At least 6 months must have elapsed from the use of fulvestrant
453
Fludarabine or Campath within 12 months prior to study entry
454
Patients are excluded if they have a history of hemoptysis (bright red blood of 1/2 teaspoon or more per episode) within 3 months prior to randomization
455
Inclusion Criteria:\n\n        Phase 1a portion\n\n          -  Histologically or cytologically proven diagnosis of adenocarcinoma of the breast with\n             evidence of either locally recurrent disease not amenable to resection or radiation\n             therapy with curative intent, or metastatic disease, both progressing after at least 6\n             months of hormonal therapy for estrogen receptor (ER) positive breast cancer\n\n          -  ER-positive, human epidermal growth factor 2 (HER2) negative\n\n          -  At least 2 months must have elapsed from the use of tamoxifen\n\n          -  At least 6 months must have elapsed from the use of fulvestrant\n\n          -  At least 2 weeks must have elapsed from the use of any other anticancer hormonal\n             therapy\n\n          -  At least 3 weeks must have elapsed from the use of any chemotherapy\n\n          -  Postmenopausal status\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2\n\n          -  Adequate organ function\n\n        Phase Ib portion\n\n          -  All above inclusion criteria, except:\n\n          -  Postmenopausal status, pre- and peri-menopausal participants will also be included\n\n          -  ECOG performance status less than 2\n\n          -  At least 2 months must have elapsed from the use of tamoxifen not applicable\n\n          -  At least 6 months must have elapsed from the use of fulvestrant not applicable\n\n        and plus:\n\n          -  Documented sensitivity to prior hormonal therapy\n\n          -  Cohort C1 (palbociclib combination cohorts): no prior treatment with cyclin-dependent\n             kinase (CDK) 4/6 inhibitor\n\n        Phase IIa portion\n\n          -  All above inclusion criteria for Phase Ia, except:\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n\n          -  At least 6 months must have elapsed from the use of fulvestrant not applicable\n\n        and plus:\n\n          -  Cohort A only: confirmed estrogen receptor alpha (ESR1) mutation and presence of\n             measurable disease as per RECIST v1.1 or evaluable bone disease\n\n          -  Cohort A1 only: no prior fulvestrant allowed; at least 2 months must have elapsed from\n             the use of tamoxifen\n\n          -  Cohort A2 only: prior fulvestrant allowed\n\n          -  Cohort B only: disease progression following no more than 1 prior treatment with an\n             aromatase inhibitor in the advanced/metastatic setting\n\n          -  Cohort B1 only: no prior fulvestrant allowed\n\n          -  Cohort B2 only: prior fulvestrant allowed\n\n        Exclusion Criteria:\n\n        Phase 1a portion\n\n          -  Untreated or symptomatic central nervous system (CNS) metastases\n\n          -  Endometrial disorders\n\n          -  More than 2 prior chemotherapy in the advanced/metastatic setting (prior adjuvant\n             chemotherapy is allowed so long as it occurred greater than or equal to 12 months\n             prior to enrollment)\n\n          -  Current treatment with any systemic anticancer therapies for advanced disease\n\n          -  Any significant cardiac dysfunction within 12 months prior to enrollment\n\n          -  Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or upper\n             gastrointestinal surgery including gastric resection\n\n          -  Known human immunodeficiency virus (HIV) infection\n\n          -  Known clinically significant history of liver disease\n\n          -  Major surgery within 4 weeks prior to enrollment\n\n          -  Radiation therapy within 2 weeks prior to enrollment\n\n        Phase Ib portion - all above exclusion criteria, plus:\n\n          -  Cohort C1 (palbociclib combination cohorts): history of venous thromboembolic event\n             requiring therapeutic anticoagulation; vaginal bleeding within 2 months prior to\n             enrollment\n\n        Phase IIa portion - all above exclusion criteria, plus:\n\n          -  Cohort A1, A2, and Cohort B2 only: more than 1 prior chemotherapy in the\n             advanced/metastatic setting\n\n          -  Cohort B1 only: prior chemotherapy in the advanced/metastatic setting
456
Males must agree to take appropriate precautions to avoid fathering a child from screening until 3 months after their last dose of study medication
457
Treated with eculizumab for PNH for at least 6 months prior to Day 1
458
Unstable medical conditions (eg, myocardial ischemia, active gastrointestinal bleed, severe congestive heart failure, anticipated need for major surgery within 6 months of randomization, coexisting chronic anemia unrelated to PNH)
459
Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
460
unstable angina (angina symptoms at rest) within less than or equal to 3 months prior to randomization; and
461
Investigational treatment within 4 weeks prior to leukapheresis; experimental anti-cancer vaccine within 2 months prior to leukapheresis in the absence of response or in the opinion of the Investigator is responding to an experimental vaccine given within 6 months prior to leukapheresis; any prior gene therapy using an integrating vector.
462
Radiotherapy that involves the lung or mediastinum within 3 months prior to chemotherapy. (Note: there is no washout period for palliative radiation to non-target organs other than the lung or mediastinum. If radiation was to an intended target lesion within 3 months of baseline imaging studies, and the lesion is progressing within this time frame it may be considered as a target lesion after review and discussion with the Sponsor.)
463
No unstable angina pectoris < 6 months
464
Hepatic artery embolization or ablation of hepatic metastasis within 3 months of enrollment, prior peptide receptor radionuclide therapy (PRRT) within 4 months or any other cancer therapy within 4 weeks (as long as all toxicities are resolved)
465
Have stable renal function without dialysis for at least 2 months prior to Investigational Product (IP) administration defined by:
466
Previous treatment with Samarium-153, Strontium-89, Rhenium-186 or Radium-223 within 6 months of starting (i.e., Cycle 1 Day 1) EC1169
467
The subject has had a hypoglycemic episode requiring medical intervention while on insulin (or other anti-diabetic) treatment within 12 months before Day 1.
468
New onset seizures (within 3 months prior to Screening) or poorly controlled seizures.
469
Prior liver resection must have taken >2 months prior to randomization
470
Expected survival of at least 6 months
471
Androgen deprivation therapy started prior to prostatectomy for > 6 months (180 days) duration; \r\n* Note: The use of finasteride or dutasteride (± tamsulosin) for longer periods prior to prostatectomy is acceptable
472
Immunotherapy within 6 months of C1D1
473
Unstable medical conditions (eg, myocardial ischemia, active gastrointestinal bleed, severe congestive heart failure, anticipated need for major surgery within 6 months of randomization, coexisting chronic anemia unrelated to PNH).
474
For women who are not postmenopausal (< 12 months of non therapy-induced amenorrhea, with no identified cause other than menopause) and have not undergone surgical sterilization (removal of ovaries and/or uterus): agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate non hormonal methods of contraception, including at least one method with a failure rate of < 1% per year, during the treatment period and for at least 4 months after the last dose of study drug
475
have experienced any arterial thromboembolic event within 6 months prior to enrollment
476
have experienced any Grade 3 or 4 venous thromboembolic event that is considered by the investigator to be life threatening or that is symptomatic and not adequately treated by anticoagulation therapy, within 6 months prior to enrollment
477
have a history of GI perforation and/or fistulae within 6 months prior to enrollment
478
Anticipated lifespan greater than 3 months
479
Have a history of gastrointestinal perforation and/or fistulae within 6 months prior to randomization.
480
Has had encephalopathy in the last 6 months. Participants on rifaximin or lactulose to control their encephalopathy are not allowed
481
Has symptoms of bowel obstruction in the past 3 months
482
Stroke or other symptoms of cerebral vascular insufficiency within the last 3 months.
483
Evidence or history of thromboembolic, venous, or arterial events within the past 3 months
484
Subjects with active HBV infection need to be on anti-HBV suppression ?3 months, throughout treatment and for 6 months after
485
disease recurrence either must occur within 12 months of the most recent intravesical therapy of any kind, OR
486
disease recurrence within 18 months of BCG maintenance OR
487
disease recurrence within 24 months of BCG induction
488
If treated with a lenalidomide and dexamethasone combination, progression during the first 3 months after initiating treatment.
489
Have a history of gastrointestinal perforation and/or fistulae within 6 months prior to randomization.
490
Unstable angina within the last 6 months prior to registration
491
Expected survival > 12 weeks at the time of screening
492
On treatment with eculizumab (Soliris®) for at least 3 months
493
Active hepatitis B, unless patient has been on antiviral agents for at least 2 months (baseline testing not required)
494
Active brain metastases: evidence of progression =< 3 months after local therapy (patients should be asymptomatic and off corticosteroids and anticonvulsants for at least 3 months prior to study entry)
495
History of gross hemoptysis within 2 months of study entry.
496
Radiotherapy (except extremities) within 3 months prior to baseline imaging
497
Ipsilateral mammogram done greater than 6 months prior to study
498
Patients must be between 2-6 months post-transplantation at the time of study registration
499
Cerebral Vascular Accident (CVA) within 3 months prior to consent.
500
No radioimmunotherapy within 2 months prior to registration
501
Inclusion Criteria:\n\n          -  Be at least 12 years of age\n\n          -  Have a documented (medical record) diagnosis of either pheochromocytoma or\n             paraganglioma\n\n          -  Be ineligible for curative surgery for pheochromocytoma\n\n          -  Have failed a prior therapy for pheochromocytoma/paraganglioma or are not candidates\n             for chemotherapy or other curative therapies\n\n          -  Be on stable antihypertensive medication for pheochromocytoma-related hypertension for\n             at least 30 days\n\n          -  Have at least one tumor site by CT or MR or iobenguane I 131 scan\n\n          -  Have an expected survival of at least 6 months\n\n          -  Subjects must agree to use an acceptable form of birth control (abstinence, IUD, oral\n             contraception, barrier and spermicide or hormonal implant) during this study and for 6\n             months following Therapeutic Doses of Ultratrace Iobenguane I 131.\n\n          -  Male subjects must agree not to father a child during the period beginning immediately\n             after administration of the first Therapeutic Dose of Ultratrace Iobenguane I 131\n             during the study and ending six months after administration of the last Therapeutic\n             Dose of Ultratrace Iobenguane I 131.\n\n        Exclusion Criteria:\n\n        Subjects will be excluded if any of the following conditions are observed:\n\n          -  <50% of FDG (if data are available) positive lesions are MIBG avid\n\n          -  Pregnant or nursing females\n\n          -  Active CNS lesions by CT/MR scanning within 3 months of study entry\n\n          -  New York Heart Association class IV heart failure, symptomatic congestive heart\n             failure [New York Heart Association class IV with another medical disorder], unstable\n             angina pectoris, cardiac arrhythmia\n\n          -  Received any previous systemic radiotherapy resulting in marrow toxicity within 3\n             months of study entry or have active malignancy (other than\n             pheochromocytoma/paraganglioma) requiring additional treatment during the active phase\n             or follow up period of the Ultratrace® iobenguane I 131 trial.\n\n          -  Administered prior whole-body radiation therapy\n\n          -  Received external beam radiotherapy to > 25% of bone marrow\n\n          -  Administered prior chemotherapy within 30 days or have active malignancy (other than\n             pheochromocytoma/ paraganglioma) requiring additional treatment during the active\n             phase or follow up period of the Ultratrace iobenguane I 131 trial.\n\n          -  Karnofsky Performance Status is < 60\n\n          -  Platelets < 80,000/?L\n\n          -  Absolute neutrophil count (ANC) < 1,200/?L, Total bilirubin > 1.5 times the upper\n             limit of normal, AST/SGOT or ALT/SGPT > 2.5 times the upper limit of normal\n\n          -  Diagnosed with AIDS or HIV-positive\n\n          -  Active chronic alcohol abuse, chronic liver disease or hepatitis\n\n          -  Renal dysfunction/impairment\n\n          -  Known allergy to iobenguane that has required medical intervention\n\n          -  Received a therapeutic investigational compound and/or medical device/prior\n             chemotherapy within 30 days before admission into this study\n\n          -  Receiving a medication which inhibits tumor uptake of iobenguane I 131\n\n          -  Any medical condition or other circumstances (i.e., uncontrolled current illness\n             including but not limited to, ongoing or active infection or psychiatric\n             illness/social situations that would limit compliance with the study requirements.\n\n          -  Any other condition, that in the opinion of the investigator, may compromise the\n             safety or compliance of the subject or would preclude the subject from successful\n             completion of the study
502
Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis
503
Ability to comply with endometrial biopsies every 3 months
504
Patients who have not been treated or who have received chemotherapy within 6 months, or SCT within 12 months, for the light-chain producing hematologic disease causing AL amyloidosis, at the time of the first dose of NEOD001 (month 1 day 1)
505
Is not post-menopausal (defined as amenorrhea >12 consecutive months).
506
Patients with chronic myeloid leukemia (CML) in chronic phase who have resistance and/or intolerance to frontline TKI therapy; resistance is defined as lack (lack defined as response not achieved or lost by the given dates mentioned hereafter) of CHR (complete hematologic response) within 3 months, lack of major cytogenetic response (MCyR) within 6 months, and lack of CCyR within 12 months of therapy with frontline TKIs; in addition, loss of MCyR, CCyR or MMR at any time during the course of therapy is also considered resistance to therapy; intolerance is defined as persistent or severe toxicity that is unacceptable to the patient
507
The following are additional exclusion criteria for patients enrolling post safety run in:\r\n* Any clinical or radiographic evidence of a partial or complete bowel obstruction (small or large bowel) currently or within the past 6 months\r\n* No current dependency on total parental nutrition (TPN) or within the past 30 days
508
Has undergone a colectomy procedure in the previous two months
509
Radiotherapy to the target lesion within the past 3 months prior to baseline imaging
510
Inclusion Criteria:\n\n        Disease-specific inclusion criteria:\n\n          -  Histologically confirmed adenocarcinoma originating from the colon or rectum (Stage 4\n             American Joint Committee on Cancer [AJCC] 7th edition)\n\n          -  Experienced disease progression or was intolerant to at least two systemic\n             chemotherapy regimens for metastatic colorectal cancer that must have included\n             fluroropyrimidines, irinotecan, and oxaliplatin; adjuvant regimen can be considered as\n             one chemotherapy regimen for metastatic disease if the participant had disease\n             recurrence within 6 months of completion; disease progression must have occurred\n             within 3 months of the last systemic therapy administration\n\n        General inclusion criteria:\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\n          -  Anticipated life expectancy greater than or equal to (>=) 3 months\n\n          -  Adequate hematologic and end organ function\n\n          -  Women of childbearing potential must agree to appropriately use an effective form of\n             contraception (failure rate of less than [<] 1 percent [%] per year) during the\n             treatment period, within 5 months after the last dose of atezolizumab, and within 3\n             months after the last dose of cobimetinib and regorafenib\n\n          -  Men must agree not to donate sperm or have intercourse with a female partner without\n             using appropriate barrier contraception during the treatment period and for 3 months\n             after the last dose of either cobimetinib or regorafenib\n\n          -  Provide an archival or newly obtained tumor tissue sample\n\n        Exclusion Criteria:\n\n          -  After the approximate 5% cap for microsatellite (MSI)-high participants is reached,\n             only MSI-stable participants will be eligible\n\n          -  Once the 50% cap for wild-type RAS has been reached, only extended RAS-mutant\n             participants will be eligible\n\n          -  Major surgery or radiotherapy within 21 days prior to Cycle 1 Day 1 or anticipation of\n             needing such procedure while receiving study treatment\n\n          -  Treatment with any anti-cancer agent within 14 days prior to Cycle 1 Day 1\n\n          -  Uncontrolled tumor-related pain. Participants requiring narcotic pain medication must\n             be on a stable regimen at study entry\n\n          -  Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated\n             drainage more than once every 28 days. Indwelling drainage catheters (e.g., PleurX®)\n             are allowed\n\n          -  Active or untreated central nervous system (CNS) metastases are excluded\n\n          -  Prior therapy with any cancer immunotherapy, MEK inhibitor, or regorafenib\n\n          -  Participants with active malignancy (other than CRC) or a prior malignancy within the\n             past 3 years are excluded. Participants with completely resected cutaneous melanoma\n             (early stage), basal cell carcinoma, cutaneous squamous cell carcinoma, cervical\n             carcinoma in-situ, breast carcinoma in-situ, and localized prostate cancer are\n             eligible\n\n          -  Unstable angina, new onset angina within last 3 months, myocardial infarction within\n             last 6 months and current congestive heart failure New York Heart Association Class II\n             or higher\n\n          -  Left ventricular ejection fraction (LVEF) below institutional lower limit of normal or\n             below 50%, whichever is lower\n\n          -  Poorly controlled hypertension, defined as a blood pressure consistently above 150/90\n             millimeters of Mercury (mmHg) despite optimal medical management\n\n          -  Human immunodeficiency virus (HIV) infection\n\n          -  Active tuberculosis infection\n\n          -  Severe infections within 2 weeks prior to Cycle 1 Day 1\n\n          -  Active or chronic viral hepatitis B or C infection\n\n          -  History of or evidence of retinal pathology on ophthalmologic examination that is\n             considered a risk factor for central serous retinopathy, retinal vein occlusion, or\n             neovascular macular degeneration\n\n          -  Participants will be excluded if they currently have any of the risk factors as\n             defined in the study protocol for retinal vein occlusion\n\n          -  History of autoimmune disease\n\n          -  History of idiopathic pulmonary fibrosis, organizing pneumonia, bronchiolitis\n             obliterans, drug-induced pneumonitis, or idiopathic pneumonitis\n\n          -  History of organ transplantation including allogeneic bone marrow transplantation\n\n          -  Inability to swallow medications\n\n          -  Malabsorption condition that would alter the absorption of orally administered\n             medications\n\n          -  Pregnant, lactating, breastfeeding, or intending to become pregnant during the study\n\n          -  Administration of a live, attenuated vaccine within 4 weeks before randomization or\n             anticipation of a live attenuated vaccine will be required during the study
511
For the ibrutinib arm only: participants must not currently require ongoing anticoagulation for any reason, or have had any major bleeding events within 6 months of enrollment
512
Patients may sign screening consent during recurrence or at time of remission if they can start vaccine therapy within 4 months of completing chemotherapy
513
For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or to use contraceptive methods that result in a failure rate of less than (<) 1% per year during the treatment period for greater than or equal to (>=) 5 months after last dose of Atezo, >= 12 months after last dose of rituximab, >= 12 months after last dose of Pola, and >= 18 months after last dose of obinutuzumab
514
No more than 3 years of ADT is allowed, with the most recent ADT treatment having occurred greater than 6 months prior to enrollment
515
Self-report of regular menstrual cycles >= 6 months (female only)
516
Current or planned pregnancy within the next three months (females only)
517
Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV diagnoses for psychotic disorders, bipolar disorder, attention deficit hyperactivity disorder (ADHD), major depressive disorder within the last 3 months, substance dependence within the last 3 months with the exception of nicotine and marijuana dependence
518
Unstable psychotropic medications (< 3 months)
519
Expected survival duration of > 3 months
520
Uncontrolled angina within 6 months before the Day 1 visit.
521
Subject underwent transplantation at least 3 months prior to enrollment
522
The participant has a history of arterial thromboembolism event (ATE) or venous thromboembolism event (VTE) within 3 months prior to study enrollment. Participants with history of VTE beyond 3 months prior to study enrollment can be enrolled if they are appropriately treated with low molecular weight heparin.
523
Acute thrombosis within 3 months of screening
524
Patients who have received antiandrogens such as flutamide (EULEXIN®), bicalutamide (CASODEX®), or nilutamide (NILANDRON®) for > 3 months must be off treatment for 6 weeks and demonstrate a continued rise in PSA after withdrawal. Patients on antiandrogens for < 3 months must be off medication for 2 weeks. Patients on 5 alpha reductase inhibitors such as finasteride (PROSCAR®, PROPECIA®), or dutasteride (AVODART®) must stop medication at least 3 months from study entry.
525
Prior exposure to cardiotoxic agent, such as anthracyclines, within 3 months of enrollment
526
Participants may not have current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting study drugs
527
Postmenopausal defined as no menses for 12 or more months without an alternative medical cause OR
528
Minimum of 6 months since last chemotherapy, biologic therapy (i.e., trastuzumab), radiation therapy, and/or breast surgery and no evidence of recurrent disease; minimum of 6 months since completion of adjuvant tamoxifen; current use of a third generation aromatase inhibitor [AI] (i.e., anastrozole, letrozole, exemestane) is permitted, provided that the participant has been on a stable dose for the past 6 months
529
History of or plans for bilateral mastectomies within the next 12 months
530
Thromboembolism within 6 months of screening visit
531
Anticipated survival of at least 6 months
532
Patients with torsades de pointes within 12 months of study entry
533
Patients are eligible if an autologous transplant is planned within approximately 12 months from the time of collection of cells
534
Willing and able to participate in clinic visits and study interactions at specified intervals and to maintain contact with the investigators for at least three months
535
History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
536
Molecular diagnosis of CP CML of ? 6 months (from initial diagnosis).
537
Expected survival > 6 months
538
Expansion cohort only (if conducted in the study): men with mCRPC and disease progression as defined by PCWG2 within 6 months (primary resistance); or after at least 6 months of treatment (acquired resistance) of starting treatment with abiraterone acetate; at least 4 weeks must have elapsed from the last dose of abiraterone acetate
539
At least 6 weeks must have elapsed from the use of bicalutamide if used as part of an initial combined androgen blockage therapy for more than 6 months or if used as second line hormonal therapy and associated with a PSA response of at least 3 months duration
540
Splenic irradiation within 3 months prior to Randomization
541
Unstable angina within 6 months prior to first dose
542
Progression of glioma must have occurred over 12 months or less.
543
Subjects must have expected survival of ?3 months.
544
No known contraindications to anti-angiogenics such as severe coronary artery disease, recent myocardial infarction or stroke within 6 months, bleeding peptic ulcer or varices within last 3 months, and any other major illness that may jeopardize study treatment or follow up
545
History of hormonal therapy for endometrial carcinoma for more than 3 months;
546
History of use of progestins for a period of longer than 3 months for any indication, including endometriosis;
547
Thromboembolism within 6 months of cycle 1, day 1
548
History of arterial thrombotic or embolic events (within 6 months prior to study entry)
549
History of arterial or embolic events (within 6 months prior to study entry)
550
Not have received bacillus Calmette-Guérin (BCG) or have completed previous BCG treatment > 12 months prior to the baseline staging procedure.
551
Active malignancies within the past 12 months except negligible risk of metastasis or death treated with expected curative outcome.
552
Participants previously treated with bendamustine only if their duration of response was >/= 24 months
553
Not appropriate for treatment with a purine-based analogue regimen (per National Comprehensive Cancer Network [NCCN] or European Society for Medical Oncology [ESMO] guidelines), including relapse ? 36 months from a purine-based chemoimmunotherapy regimen or relapse ? 24 months from a purine-based monotherapy regimen
554
A cytogenetics or fluorescence in situ hybridization (FISH) analysis of the leukemic cells within 24 months of randomization is required to document the presence or absence of del(17p). Note: if a sample from within 24 months is not available, it should be evaluated as part of the screening laboratory evaluation to inform stratification
555
Refractory to ofatumumab (progression or relapse <12 months of receiving ofatumumab therapy or <24 months of receiving an ofatumumab- containing regimen)
556
Patients with life expectancy of =< 6 months for reasons other than their underlying hematologic/oncologic disorder
557
Men must agree not to donate sperm during and after the study for 6 months after the last dose of bendamustine, 12 months after the last dose of rituximab, or 3 months after the last dose of study medication, whichever is later
558
Stratum 2: patients must have received radiation therapy, which may include gamma knife or phosphorus-32 (P32)\r\n* More than 6 months from the time of enrollment if the recurrence is predominantly solid\r\n* More than 12 months from the time of enrollment if the recurrence is predominantly cystic
559
Subjects who are anticipated to receive a transplant within the first 6 months of treatment on trial
560
Additionally, patients who were previously MRD negative for >= 3 months after induction therapy with/without consolidative HDT/ASCT and have turned MRD positive (by flow cytometry) within the last 3 months and do not have any evidence of progressive disease are eligible.
561
Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after the last dose of atezolizumab, 6 months after the last dose of bevacizumab, or 1 month after the last dose of sorafenib
562
Has a history of thromboembolic or cerebrovascular events within 6 months prior to registration
563
Alemtuzumab within 6 months prior to leukapheresis
564
Cladribine within 3 months prior to leukapheresis
565
Active malignancies within 12 months with the exception of those with a negligible risk of metastasis or death
566
Thromboembolism within 6 months of enrollment
567
Patients with the following within the last 6 months prior to registration must be evaluated by a cardiologist and/or neurologist prior to entry into the study
568
Prior treatment with Gliadel wafer is allowed if it has been at least 3 months from placement
569
Patients treated with interferon or other anti-HCV therapy within 3 months prior to study entry
570
On beta-blocker treatment; if discontinued, patients must have been off beta-blockers for at least 3 months
571
Expected survival of at least 3 months
572
Expected survival > 3 months
573
Expected survival ? 6 months.
574
Expected survival > 2 months
575
Patients may have been treated with up to 4 months of androgen deprivation therapy
576
Prior androgen deprivation therapy (ADT) allowed if last dose was greater than (>) 6 months prior to randomization
577
Expected survival time of >= 3 months in the opinion of the investigator
578
Expected survival ?4 months.
579
Treatment initiation with BST no longer than 6 months prior to randomization
580
Expected survival > 12 weeks
581
Patients must be registered within 6 months of last dose of lenalidomide
582
Minimum of 3 months of maintenance therapy prior to disease progression
583
Patients who have taken any benzimidazole (ABZ, flubendazole, thiabendazole, fenbendazole, triclabendazole, etc.) within the last 3 months
584
Patient has been treated with nelfinavir within 3 months of entry into this trial
585
History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
586
Agreement not to donate blood or blood products during the study and for at least 6 months after discontinuation of vemurafenib; for male partners, agreement not to donate sperm during the study and for at least 6 months after discontinuation of vemurafenib
587
No active alcohol addiction (as assessed by medical caregiver and defined as at least 6 months without activity)
588
Dose reductions due to neutropenia or thrombocytopenia in the past 6 months
589
Expected survival time of >= 3 months in the opinion of the investigator
590
History of venous or arterial thromboembolism within 12 months prior to enrollment/randomization
591
No CVA within 6 months, no MI within 6 months
592
History of treatment-resistant peptic ulcer disease, erosive esophagitis, gastritis, or diverticulitis within 3 months
593
No history of gross hemoptysis (defined as bright red blood of a half-teaspoon or more) within 3 months prior to enrollment
594
Irradiation: interval from the last dose of local RT, craniospinal RT, and palliative RT for symptomatic disease >= 3 months, >= 6 months, and >= 2 weeks before study enrollment, respectively
595
High-dose chemotherapy with stem-cell rescue: interval >= 3 months before study enrollment
596
Patients must be off hydroxyurea (HU) or erythropoietin (EPO) treatment for at least three months prior to entry onto the study
597
Recent exposure to cardiotoxic agents (including anthracyclines) within 3 months of enrollment. Subjects with troponin-I and BNP levels above ULN are excluded.
598
Prior myeloablative transplant within previous 3 months of study enrollment
599
Prior/concurrent therapy including:\r\n* Tamoxifen, raloxifene, letrozole, anastrozole, or exemestane in the past 6 months\r\n* Chemotherapy, biologic therapy (e.g., trastuzumab [Herceptin]), or breast radiotherapy to the breast currently affected by DCIS within the past 12 months\r\n* Any exogenous hormonal therapy including estrogen-, progesterone-, and/or androgen-based agents in the past 6 months\r\n* Phytoestrogens or over-the-counter (OTC) medications with estrogenic or androgenic properties in the past 6 months\r\n* Any black cohosh preparation within the past 6 months
600
Receipt of an experimental vaccine within 2 months or in the opinion of the Investigator is responding to an experimental vaccine given within 6 months, or has received any previous gene therapy using an integrating vector
601
Were postmenopausal for at least 24 months before the screening visit, OR
602
History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
603
Additional exclusions for the 3 pazopanib containing arms (crizotinib plus pazopanib) and (pazopanib plus pemetrexed) and (crizotinib plus pazopanib plus pemetrexed):\r\n* History of stroke or transient ischemic attack within 6 months prior to study enrollment\r\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment\r\n* Urine for proteinuria >= 2+ (patients discovered to have >= 2+ proteinuria on urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate =< 1 g of protein in 24 hours to be eligible)
604
History of hemoptysis >= grade 2 (defined as bright red blood of at least 2.5 mL) =< 3 months prior to randomization
605
Anticipated patient survival under 3 months
606
History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
607
Prior surgical endoscopic intervention within the past six months for Spigelman Stage 3 or 4 that may have been down staged to Spigelman 1 or 2.
608
Hospitalization for bowel obstruction within 3 months prior to enrollment.
609
Presence of any other medical complications that imply a survival of less than six months
610
Asymptomatic carriers of hepatitis B virus can be considered for study if they agree to and comply with close monitoring and suppressive therapy with lamivudine during treatment and for additional six months after coming off study.
611
History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms
612
Expected survival time of at least 3 months in the opinion of the investigator
613
Patients who had radiosurgery > 3 months prior to registration are eligible
614
History of peptic ulcer within the last 6 months
615
AML relapsed > 2 months after transplant
616
History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
617
Use of bevacizumab or vascular endothelial growth factor inhibitor chemotherapy within 3 months before RT or 6 months after RT
618
Completed cancer specific therapy at most 6 months prior to entry
619
Reasonable expectation that no chemotherapy will be given in the subsequent 6 months (principal investigator's [PI’s] discretion)
620
Received anti-thymocyte globulin (ATG) within 6 months of screening
621
Biochemical or radiologic documentation of disease progression within the last 12 months prior to enrollment
622
Patients must have had FISH evaluation of leukemia cells within 3 months without intervening treatment demonstrating deletion 11q22-23
623
Constitutional symptoms related to CLL/SLL: \r\n* Fever > 100.5 degrees Fahrenheit (F) for >= 2 weeks or night sweats for > 1 month, both without evidence of infection\r\n* Unintentional weight loss of >= 10% body weight in previous 6 months\r\n* Extreme fatigue (ECOG PS > 2; inability to work or perform usual activities)\r\n* Lymphocyte doubling time of =< 6 months or 50% increase in absolute lymphocyte count within 2 months\r\n* Progressive anemia (Rai stage III) or thrombocytopenia (Rai stage IV)\r\n* Recurrent infections unrelated to hypogammaglobulinemia\r\n* Autoimmune phenomenon poorly responsive to corticosteroids or other standard therapy\r\n* Massive, progressive or symptomatic lymphadenopathy (> 10 cm in longest diameter) or splenomegaly (> 6 cm below left costal margin)
624
Subject did not receive more than 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression
625
Open-label day 1 visit is within 6 months after this amendment is approved and becomes effective at the study site;
626
History of intracerebral abscess within 6 months prior to Day 1
627
Patients who have received other agents that modulate or downregulate the estrogen receptor (e.g. raloxifene, fulvestrant) in the locally advanced or metastatic setting are eligible if they were on treatment for at least 6 months and must have discontinued these agents 6 months prior to study registration
628
Unstable angina pectoris ?6 months prior to study participation
629
History of small or large bowel obstruction within 3 months of registration, including subjects with palliative gastric drainage catheters; subjects with palliative diverting ileostomy or colostomy are allowed if they have been symptom free for more than 3 months
630
Uncontrolled CHF (NYHA Class 2-4), angina, MI, CVA, coronary/peripheral artery bypass graft surgery, TIA, or PE in prior 3 months;
631
Any contra-indications to bevacizumab which include but are not limited to recent\r\n* Any previous venous thromboembolism > National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 3\r\n* Severe uncontrolled hypertension (systolic blood pressure >= 150 mmHg and/or diastolic blood pressure >= 100 mmHg)\r\n* Cardiovascular disease including stroke of myocardial infarction =< 6 months prior to study enrollment, New York Heart Association grade 2 or greater congestive heart failure, serious cardiac arrhythmia uncontrolled by medication\r\n* Hemorrhagic brain metastases; asymptomatic (not requiring escalating doses of steroids) brain metastases are acceptable\r\n* History of severe proteinuria (urine dipstick >= 2+ or 24 hour [hr] urine > 2 gm/24 hr)\r\n* Prior history of hypertensive crisis or hypertensive encephalopathy\r\n* History of a central nervous system disease (e.g. seizures) unrelated to cancer unless adequately treated with standard medical therapy\r\n* Significant vascular disease (e.g. aortic aneurysm requiring surgical repair) =< 6 months prior to study enrollment\r\n* History of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within the last 3 months\r\n* Evidence of a bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)\r\n* Current or recent (within 10 days of study drug start) use of aspirin (> 325 mg daily), clopidogrel (> 75 mg daily)\r\n* Recent initiation of full dose oral or parental anticoagulants that have not been in place for at least 2 weeks\r\n* Tumor invading or abutting major blood vessels\r\n* Tumor histology classified by squamous cell histology\r\n* Any history of abdominal fistula or gastrointestinal tract (GI) perforation within 6 months of study enrollment
632
Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting study drugs
633
History of cerebral vascular accident (CVA) within 6 months
634
Estimated >4 months survival probability.
635
Expected survival duration of >= six months
636
Systemic infection that has not resolved > 2 months prior to initiating lenalidomide
637
History of thromboembolic disease within the past 6 months regardless of anti-coagulation
638
All patients with a diagnosis of complex atypical hyperplasia or endometrial biopsy within three months of study enrollment OR patients with a diagnosis of grade 1 endometrioid endometrial carcinoma on endometrial biopsy within three months of study enrollment in the presence of one or more of the following: 1) desire for future fertility 2) morbid obesity (body mass index > 40) 3) multiple co-morbidities (American Society of Anesthesiology [ASA] class 3 or 4)
639
Ability to comply with endometrial biopsies every 3 months
640
Negative bone scan within 6 months prior to enrollment to rule out possibility of metastases;
641
use of any 5ARI drugs within 3 months prior to enrollment such as Finasteride (Proscar) or Dutasteride (Avodart);
642
Patients taking chronic erythropoietin are permitted provided no dose adjustment is made within 2 months prior to start of first dose.
643
The patient has progressed within 6 months after completion of curative intent (definitive) treatment for localized/locoregionally advanced disease.
644
Myeloma relapsing from partial response or better\r\n* Patients relapsing > 18 months from transplant if not on maintenance, or\r\n* If off maintenance, discontinued at least 6 months ago, or\r\n* If relapsing on maintenance, at least 3 years from transplant, or\r\n* Off prior myeloma therapy at least 6 months ago\r\n* Sufficient tumor burden that is assessable for response\r\n** Serum M-spike >= 0.5 g/dL, or\r\n** If immunoglobulin A (IgA) myeloma, IgA > 1000 mg/dL, or\r\n** Difference between involved and uninvolved free light chain (dFLC) > 10 mg/dL, or\r\n** Urine M-spike >= 200 mg/24 hours, or\r\n** Bone marrow plasmacytosis >= 10%, or\r\n** Plasmacytoma >= 2 cm in diameter
645
Exposure to household contacts =< 15 months old or household contact with known immunodeficiency
646
Expected survival >= 3 months from study entry
647
Cardio or cerebral vascular event within 6 months
648
Progression should have occurred within the immediate prior 2 months of the time of screening visit, with no intervening anti-cancer therapy
649
Male subjects must not donate sperm during the Screening and Treatment periods, and for at least 3 months after the last dose of ALXN1007.
650
Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis
651
Males must agree not to donate semen or sperm for 3 months after last dose of CC-122.
652
Anticipated patient survival under 2 months
653
Splenic irradiation 3 months prior to enrollment.
654
Anticipated survival of at least 6 months
655
Less than 12 months since diagnosis
656
Vasectomy or other procedure resulting in infertility (eg, bilateral orchiectomy) for >6 months
657
Predicted not to have significant clinical progression at 4 months
658
Previously enrolled and treated for at least 9 months in Study NEOD001-001
659
Patients with life expectancy of =< 6 months for reasons other than their underlying hematologic/oncologic disorder or complications there from
660
Documented objective response or stable disease lasting for 6 months or more to last prior anti-EGFR (cetuximab or panitumumab) in combination with irinotecan or FOLFIRI
661
Prior treatment with docetaxel within 6 months of enrollment
662
History of arterial or venous embolism within 3 months prior to study enrollment. If the embolism occurred >3 and <6 months, the participant is eligible provided appropriate treatment according to institutional standard of care is ensured.
663
Vasectomy or other procedure resulting in infertility (e.g., bilateral orchiectomy), performed at least 6 months before screening
664
History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
665
Expected survival ? 6 months.
666
Subject with prior history of thrombotic microangiopathy or HUS within 3 months prior to enrollment
667
Refractory to obinutuzumab (defined as progression or relapse <12 months of receiving obinutuzumab monotherapy or <24 months of receiving an obinutuzumab-containing regimen)
668
History of gastrointestinal perforation and/or fistulae within 6 months prior to course 1 day 1 (C1D1)
669
Relapsed within three months post-transplant
670
Patients with advanced phase CML or acute leukemia must have failed at least one prior TKI; patients with chronic phase CML must have failed, have resistance or suboptimal response to at least two tyrosine kinase inhibitors, or have intolerance to two prior tyrosine kinase inhibitors; for patients with prior intolerance, they should have received at least 2 TKI and experienced intolerance to one TKI and resistance/suboptimal, a. failure to tyrosine kinase inhibitors will be defined per European-Leukemia-Net (ELN) recommendations, b. resistance or suboptimal response to at least two prior Abl-kinase inhibitor, specifically: i. chronic-phase with resistance to imatinib, dasatinib, nilotinib, bosutinib or ponatinib defined as 1. loss of complete cytogenetic response (CCyR) at any time or failure to achieve CCyR after >= 18 months, 2. loss of major cytogenetic response (MCyR) at any time or failure to achieve partial cytogenetic response (PCyR) after >= 12 months, 3. failure to achieve any cytogenetic response (CyR) (ie, >= 65% Philadelphia chromosome [Ph]+) after >= 6 months, 4. hematologic relapse or failure to achieve complete hematologic response (CHR) after >= 3 months, ii. chronic-phase with suboptimal response to imatinib, defined as 1. failure to achieve PCyR after >= 6 months, 2. failure to achieve CCyR after >= 12 months, iii. chronic-phase with suboptimal response to nilotinib, bosutinib, dasatinib or ponatinib, defined as 1. failure to achieve PCyR after >= 3 months, 2. failure to achieve CCyR after >= 6 months of therapy
671
Grade 3 or 4 eye disorder at study entry, unless stable and longstanding (>3 months) and unlikely to interfere with protocol-required ophthalmology assessments.
672
Anyone with a second malignancy expected to require cytotoxic chemotherapy or immune modulating therapy within 3 months of enrollment
673
Expected survival > 3 months
674
There should be no evidence for improvement in KS in the 3 months prior to study enrollment, unless there is also evidence for progression of KS in the 4 weeks immediately prior to enrollment
675
Radiotherapy within the last 2 months in the area to be treated
676
At least 6 months from prior splenic irradiation
677
Radiosensitizing doses of gemcitabine if relapse occurred at least 6 months after completion of gemcitabine;
678
Subject has known significant cardiovascular disease or cerebrovascular accident within 3 months of enrollment, or within the timeframe as stipulated in the additional criteria outlined in the protocol.
679
Women who participate in this study must agree not to breastfeed from study entry to a period of no less than four months post the HSV1716 injection
680
Progressed while receiving this gemcitabine regimen or within 3 months of completing gemcitabine
681
For subjects with liver metastases developing > 6 months after completing treatment for primary CRC and having undergone surgery with curative intent for liver metastases, a second course of chemotherapy lasting at least 3 months needs to be administered, including a fluoropyrimidine and either oxaliplatin or irinotecan or both. The second course of chemotherapy should not exceed 9 months.
682
Participation in a therapeutic research trial within the past three months
683
Expected survival of at least 4 months.
684
Significant circulatory disorders in the past 6 months
685
Patients enrolled must, in the Investigator's judgment, be healthy enough to stay on the clinical trial for three months.
686
History of certain cardiovascular conditions within the past 6 months.
687
History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
688
There should be no evidence for improvement in KS in the 3 months prior to study enrollment, unless there is evidence for progression of KS in the 4 weeks immediately prior to study enrollment
689
Has had within the past 6 months the occurrence or persistence of one or more of the following medical conditions that could not be controlled with usual medical care (e.g., required emergency care or hospitalization): hypertension, angina, congestive heart failure, diabetes, seizure disorder.
690
Completion of at least 3 months, but no more than 6 months of standard induction chemotherapy for LAPC, which may include FOLFIRINOX or gemcitabine and nab-paclitaxel, preferably within 2-4 weeks but no longer than 8 weeks
691
History of Grade 3 or greater thromboembolic events in the prior 12 months
692
Males must agree not to donate semen or sperm for the duration of the study and for 3 months after the last dose of CC-122.
693
Anticipated survival of at least 3 months
694
Prior myeloablative transplant within the last 6 months
695
Splenic irradiation within 3 months prior to the first dose of MMB
696
Have a history of GI perforation and/or fistulae within 6 months prior to receiving study drugs.
697
Participants with a history of gross hemoptysis within 2 months prior to study treatment
698
Pregnant or breastfeeding, or plan to be pregnant within projected duration of the trial, starting with the screening visit through 4 months after the last dose of mirvetuximab soravtansine (NOTE: breast milk cannot be stored for future use while the mother is being treated on study)
699
History of hemorrhagic or ischemic stroke within 6 months prior to first dose of mirvetuximab soravtansine
700
History or evidence of thrombotic or hemorrhagic disorders within 6 months prior to first dose of mirvetuximab soravtansine
701
Greater than 3 months since melanoma resection;
702
Male patients must agree not to donate sperm during the study and for 3 months after discontinuation of vismodegib
703
Subjects previously treated with a systemic photosensitizer within 4 months of screening date
704
Hemorrhagic, embolic, or thrombotic stroke within 6 months of scheduled dosing day 1;
705
History of epistaxis requiring medical/surgical intervention (such as nasal packing) within the past 6 months
706
Poorly controlled ascites and/or requirement for therapeutic paracentesis more frequently than once every 3 months.
707
Symptomatic encephalopathy within 3 months prior to the first dose of TKM-080301 and/or requirement for medication for encephalopathy.
708
Anticipated patient survival under 3 months
709
Anticipated survival under 3 months
710
Less than three months since last taxane-containing therapy.
711
have not been treated with a taxane within six months of C1D1, AND
712
Important cardiovascular events in the past 6 months.
713
Male partner sterilization, occurring at least 6 months prior to screening. For female subjects on the study, the vasectomized male partner should be their sole partner.
714
Significant intercurrent illness that will limit the patient's ability to participate in the study or may result in their death over the next 18 months
715
No known Food and Drug Administration (FDA)-approved therapy available that’s expected to prolong survival by greater than 3 months
716
On a gluten-free diet for at least 6 months
717
Both must be measured within 3 months of enrollment;
718
Recent history of cellulitis in the affected extremity (within last 3 months)
719
Unstable lymphedema (i.e. worsening symptoms/measurements in the past 3 months)
720
Statin use in the last 6 months
721
Progressive disease (PD) while receiving AR targeted therapy with abiraterone acetate or enzalutamide within 12 months of treatment initiation (?12 months) by at least one of the following:
722
Measurable metastatic disease with a target lesion that has increased in size by 20% in maximal dimension either during or within six months after treatment with chemotherapy using a gemcitabine containing regimen
723
Significant intercurrent illness that will limit the patient's ability to participate in the study or may result in their death over the next 18 months
724
Participants must have histologically confirmed intrahepatic cholangiocarcinoma (IHC) without evidence of extrahepatic metastasis within 3 months prior to study registration
725
Expected survival must be three months or greater
726
Participants with a serious medical illness which may limit expected survival to less than 3 months
727
Subjects with EGFR-mutated lung cancer may continue erlotinib if they have been on the drug for >= 3 months with stable disease or a response; erlotinib may also be continued in the case of a progressing tumor after prior response (or > 6 months stable disease)
728
Removal of stent is scheduled to occur within six months
729
History of severe haemorrhagic or thromboembolic event in the past 12 months
730
Confirmed progressive disease within 18 months of enrollment on study
731
Received regional hepatic infusion therapy within 6 months of enrollment (RFA allowed >6 months prior to enrollment)
732
Expected survival of at least 3 months.
733
Evidence of encephalopathy within last 3 months
734
History or signs of active coronary artery disease with or without angina pectoris within the last 6 months.
735
Is within 2 months of transplant from C1D1
736
Have an interval from previous neurotoxic platinums of less than 6 months and/or from previous other neurotoxic drugs less than 3 months (e.g, taxanes) unless reasonably recovered from all grades of neurotoxicity as judged by the investigator
737
Anyone with a second malignancy expected to require cytotoxic chemotherapy or immune modulating therapy within 3 months of enrollment
738
Coronary or peripheral artery bypass graft within 6 months of screening
739
Prior treatment with Gliadel wafer is allowed if it has been at least 3 months from placement
740
Time to treatment failure from doxorubicin containing regimen ? 12 months if previously treated with doxorubicin.
741
History of arterial or venous thrombotic/embolic events =< 12 months prior to registration
742
Patients with prior paclitaxel exposure are ineligible unless they are > 6 months from the conclusion of paclitaxel-based therapy
743
If receiving hydroxyurea or erythropoietin, treatment must have been prescribed for at least 6 months, with the dose stable for at least 3 months
744
Between 2 and 10 sickle cell-related pain crises in the past 12 months
745
The transplant occurred > 6 months ago
746
Recent (? 3 months) history of partial or complete bowel obstruction.
747
Exposure to high dose Ara-C within 6 months of enrollment.
748
Respiratory functions clinically stable for the preceding 3 months and expected to be stable for the next 3 months as determined by project principal investigators (PIs) and other pulmonary medicine faculty
749
Treatment with at least 2 months of abiraterone prior to progression
750
Expected survival longer than 3 months from enrollment in the study
751
Last effective dose of LHRH agonist/antagonist “expired” > 3 months prior to study entry; for example, a patient receiving LHRH agonist injection every 3 months would be eligible provided their last injection was > 6 months prior to day 1 of protocol therapy; a patient receiving LHRH agonist injections every 4 months will be eligible provided last injection was > 7 months prior to day 1 of protocol therapy
752
Use of LHRH agonist or antagonist treatment within 6 months prior to randomization.
753
Subject had a painful crisis requiring hospitalization within the preceding 14 days or has experienced > 5 hospitalizations for VOC in the prior 6 months
754
Recent initiation (within 6-months) of anti-hypertensive medication (individuals on stable therapy may be enrolled)
755
Males must agree to use condoms during sex to prevent spillage of semen for the duration of the study and for 3 months after the patient leaves the study
756
Disease progression in the past 14 months
757
Uncontrolled angina within 3 months of Screening visit;
758
History of significant cerebrovascular disease in the past 3 months or ongoing event with active symptoms or sequelae
759
The subject has experienced any of the following\r\n* Clinically-significant gastrointestinal bleeding within 3 months before the first dose of study treatment; the participant must be maintained on a prophylactic regimen for management of an upper gastrointestinal (GI) bleeding event with no evidence of recurrence and/or endoscopic confirmation of resolution of the source of a lower GI bleed\r\n* Hemoptysis of >= 0.5 teaspoon (2.5 mL) of red blood within 3 months before the first dose of study treatment\r\n* Any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment
760
History of cerebral vascular accident (CVA) within 3 months prior to registration
761
Have expected survival of ?12 months.
762
Any history of an immune-related Grade 3 adverse event attributed to prior CIT (other than hypothyroidism managed with replacement therapy) that resulted in permanent discontinuation of the prior immunotherapeutic agent and/or occurred less than or equal to (<=) 6 months prior to Cycle 1 Day 1
763
Acute active (such as tuberculosis or malaria), serious, uncontrolled infection; participants with a CD4 count =< 50/mm^3 (0.05 x 10^9/L) will be excluded if they have had an opportunistic infection within the past 3 months, or if there is evidence of resistance to antiretroviral therapy (i.e., HIV viral load >= 400 copies/mL despite combination antiretroviral therapy for at least 4 months)
764
Prior invasive malignancy other than LACC diagnosed within the past 24 months, excluding anal intraepithelial neoplasia, non-melanoma skin carcinoma, or Kaposi’s sarcoma that has not required systemic chemotherapy within the past 24 months
765
Patients may not have had more than 7 days of treatment with ketoconazole by mouth in the past 6 months
766
History of venous or arterial thromboembolism within 12 months prior to enrollment/randomization
767
Evaluation by a thoracic surgeon and a radiation oncologist within 2 months of registration
768
Any history of CVA or TIA in previous six months
769
Daily smoker for ?6 months
770
Bisphosphonate therapy currently or within the past 12 months
771
History of certain cardiovascular conditions within the past 6 months.
772
It must be at least 6 months since the last treatment with a \VPLD\ induction/re-induction type regimen (i.e. anthracycline, steroid, asparaginase and vincristine)
773
Patients with cirrhosis must have had esophagogastric endoscopy within the previous 6 months prior to study entry for the assessment of varices; if the patient has not had this done they must be willing to undergo this procedure prior to study entry
774
Previous radioimmunotherapy (RIT) within 6 months of study entry. Subjects who have received RIT must have attained a PR or CR lasting at least 6 months, and must have recovered from any hematologic or other toxicity.
775
Diagnosed venous thromboembolic disease within the preceding 6 months (patient on full dose or prophylactic anticoagulation are eligible)
776
At least 3 months must have passed since last BCG therapy or intravesical treatment for bladder carcinoma.
777
History of CVA within six months
778
Progression during the first 3 months of initiating treatment
779
The patient has received Fludarabine, Clofarabine or Cloretazine within 12 months preceding the ASCI treat-ment.
780
Current or recent pregnancy (within 12 months),
781
History of prior treatment with chloroquine for malaria within past 24 months.
782
Thrombotic or thromboembolic events within the past 6 months:
783
History of arterial thromboembolic disease within 6 months of first study treatment
784
> 18 months (mos.) and =< 35 years at the time of initial diagnosis
785
No prior treatment (patients on \watch and wait\ may enter the study if a recent biopsy [obtained within the last 6 months] is available)
786
History of a thrombotic or thromboembolic event (arterial or venous) in the past 6 months
787
Fludarabine or Campath within 12 months prior to study entry
788
Availability of subject to be observed for up to 18 months post-screening evaluation
789
Patients with a history of the arterial or venous thromboembolism within =< 12 months of study entry are not eligible
790
Female patients must agree (during the study and for 3 months after receiving the last dose of study agent, not to donate eggs (ova, oocytes) for the purposes of assisted reproduction
791
Recurrent/metastatic radioiodine refractory disease that has progressed within the past 6 months with at least 1 lesion increasing by 0.5 cm in diameter or with increasing bone metastases
792
Uncontrolled angina within 6 months prior to study entry;
793
Plan to treat with anastrozole for at least 12 months
794
Expected survival > 3 months
795
Have smoked daily or nearly every day in the previous 6 months up to the date of surgical consult AND have smoked at least one puff in the previous 7 days
796
No bevacizumab =< 3 months of study registration
797
Patients receiving ongoing hormonal therapy for breast cancer must be on the same hormonal agent for at least 3 months prior to study registration and plan to continue for the duration of the study (9 months)
798
Have practiced yoga >= 1 day a week within the 3 months prior to enrolling in the study
799
Please note, pre-menopausal will be defined as women meeting the following criteria:\r\n* Patients not currently on hormonal contraception with the presence of menses in the past 6 months\r\n* If no menstruation in the past 6 months, without hormonal manipulation, then confirmed follicle-stimulating hormone (FSH) < 23 mlU/mL\r\n* If age < 47 years and on hormonal contraception then patient will be eligible regardless of menstrual history\r\n* If age >= 47 years and on hormonal contraception then FSH confirmed < 23 mIU/mL
800
Patient enrollment must occur within 4 calendar months following completion of CRT\r\n* Reminder: after patient enrollment, baseline testing followed by randomization must occur within 2-4 months after completion of CRT
801
The patient must have an identified caregiver who is willing and able to oversee the training practice during the intervention period (ie, for 5-9 weeks starting approximately 3 months after completion of CRT)
802
Patient with a history of a thrombotic event within 12 months of starting nintedanib treatment
803
Not in a committed relationship for at least 6 months
804
Expected survival < 12 months
805
Life expectance of at least three months
806
Participants with evidence of active thromboembolic disease or a history of thromboembolism within the preceding 6 months (excluding thrombosis of a central line)
807
AIM 2: Must be a current or recent former smoker (defined as smoked within past 6 months)
808
AIM 2: Former smoker greater than 6 months
809
Enroll =< 3 months post-diagnosis (as soon as possible after diagnosis is desirable)
810
Patients must be >= 6 months from craniotomy
811
>= 6 months post active treatment
812
Already have an ongoing regular yoga practice within 2 months of study enrollment
813
History of arterial or venous thromboembolic disease 6 months prior to screening
814
Use of an anti-cancer vaccine within 2 months in the absence of tumor response, or the subject should be excluded if their disease is responding to an experimental vaccine given within 6 months.
815
Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide administration.
816
Subject is a current smoker, or has smoked within 3 months prior to enrollment, or plans to resume smoking within 3 months post-enrollment
817
Has nursed a child within 3 months of study enrollment
818
Do not smoke (no smoking during previous 12 months)
819
No active cancer therapy (excluding chemoprevention) in the past three months, and no cancer therapy currently planned in the next 6 months
820
Patient’s attending medical oncologist would not be surprised if the patient died in the next 12 months
821
Having finished radiotherapy at least two months ago
822
Have an interest in being part of a study to evaluate yoga-derived exercises and eager to practice some kind of relaxation exercise daily for 3 months
823
Patients will also be excluded if they report lower extremity (LE) surgery or injury to the LE in the past 3 months or a past medical history of primary hyperparathyroidism; or rhabdomyolysis
824
Planning on remaining in New York City (NYC) for at least 7 months
825
Licensed taxi driver for at least three months
826
At least 2 months was passed since the hysterectomy at time of visit 2
827
HSCT procedure scheduled within two months of consent
828
Active yoga practice < 3 months
829
Subjects with bipolar disorder that have experienced a manic episode within 6 months of study entry will be excluded or at the principal investigator (PI)’s discretion
830
Current or past (< 6 months) engagement in PCST for cancer
831
Those who plan on relocating outside the greater Pittsburgh area in the next 3 months of intervention.
832
Use of intravenous antibiotics within the last 6 months
833
Have a documented visit with an oncologist during the previous 6-months
834
As per medical record, =< 9 months post-RP
835
Patient is pregnant, breastfeeding, has given birth within the last 3 months or planning pregnancy within the next 12 months; if participant becomes pregnant during the course of the study, she will be removed from further participation
836
Patient is anticipating leaving the area within the next 12 months
837
Non-steroidal joint injection within the last 3 months
838
PATIENTS ONLY: Have a romantic partner with whom they have resided for a minimum of 6 months
839
Patients must report neuropathic pain for a minimum of 3 months
840
History of incontinence defined as any pad use for urinary leakage in the past 6 months
841
Active or recent (within prior 3 months) thrombus, irrespective of anticoagulation status
842
Currently (previous 6 months) engaged in structured exercise either aerobic or yoga based
843
Probability of survival is at least 6 months
844
Presence of active malabsorption disorder (e.g., flare episodes documented within the preceding 3 months, presence of symptoms requiring daily medications for control) or history of extensive small bowel resection
845
History of arterial or venous thromboembolic event within 12 months prior to study participation
846
Use of finasteride or dutasteride within 3 weeks or 6 months, respectively, of study entry
847
Antidepressant users who have been medicated for at least three months will not be excluded
848
Pain duration > 2 months
849
Having 2 clinical pain ratings of >= 3 gathered as part of their routine clinic visits at least 3 weeks apart but not more than 12 months apart
850
Treatment for serious psychological disorders (e.g., schizophrenia) in the last 6 months
851
Current or past (< 6 months) engagement in pain coping skills training protocol for cancer
852
Neutrophil count less than 500 within 6 months prior to study enrollment
853
Deep venous thrombosis (DVT) diagnosed within 12 months of study enrollment or history or untreated lower extremity DVT, bone metastases, currently active skin infection, or lymphedema currently involving the treatment field
854
Patients must have had a transrectal ultrasound (TRUS)/endoscopic ultrasound (TEUS) staging within two months prior to treatment start
855
SUBJECT: A child has plans to start a new treatment for attention/memory problems in the next 3 months.
856
Loss of a child at least 6 months ago who had been diagnosed with cancer as reported in the child's medical record or by parent report
857
Expected survival of at least 3 months
858
Multiple or bilateral renal masses when more than one mass is operated on at the same time or within 4-months of each other
859
Negative se rum pregnancy test and not planning to be pregnant in the next 3 months
860
Inability to conceive after 6 months of unprotected intercourse with male
861
Substance use disorder within the prior six months
862
Greater than 6-months post diagnosis
863
Participated in an investigational study for radiation dermatitis within 3 months of the screening visit
864
History of active opioid abuse within the past 12 months
865
Separate episode of VTE or arterial thrombosis within 3 months of enrollment
866
Major bleed (WHO grade 3 or 4) within 6 months of enrollment
867
Medical conditions precluding participation in the intervention or likely to lead to death within 6 months, as determined by the principal investigator (PI)
868
Attending physician assessment of prognosis with expected life expectancy of > 2 months
869
Patients must have had neuropathic symptoms for a minimum of 3 months.
870
Use of ginseng capsules for fatigue, within the last 12 months
871
History of substance dependence in the past six months
872
Current suicide risk or significant intentional self-harm in the last six months sufficient to preclude treatment on an outpatient basis
873
Adult patients with hematologic malignancy who underwent an allogeneic HCT at least 3 months prior to study enrollment
874
Chronic use of any herbal or dietary supplement containing apigenin within the 3 months prior to entry on the study
875
Patients participating in a structured exercise program in the past 6 months (mos)
876
6 months post-treatment completion
877
All other oncology patients that will receive chemotherapy with/without transplant must have, or be scheduled to have, an external tunneled CVC (Broviacs, Hickmans, tunneled PICCs, etc.) that is expected to remain in place for an additional >= 3 months
878
Current or past (< 6 months) engagement in PCST for cancer
879
Require psychotherapy within the last three months
880
Expect to relocate from Northeast Ohio within 2 months
881
Pain or symptoms of CIPN of >= 3 months duration, for which the patient wants intervention\r\n* Note: neurotoxic chemotherapy must have been completed >= 3 months prior to registration and there must be no further planned neurotoxic chemotherapy for > 5 months after registration
882
Current suicidal ideation or suicide attempt within past 3 months
883
Treatment expected to last no longer than 12 months (patient)
884
Treatment expected to last longer than 12 months since this will make it impossible to deliver the end of therapy survivorship care planning session within the study timelines (patient)
885
Completed treatment for stage 1-3 breast cancer at least two months but not more than 24 months prior to enrollment.
886
Eligible after 2 months of completing all their active cancer treatment with the exception of long-term hormonal treatments or trastuzumab.
887
Current/recent (prior 12 months) pregnancy
888
Prior use of acupuncture within 3 months prior to the study entry
889
Recent history of attending regular QMBE or similar classes (e.g. yoga or tai chi classes i.e. 20 or more classes in the past 6 months)
890
Six to 36 months post treatment
891
Willing to travel to MD Anderson’s main campus for 2 visits (baseline and 6 months post-baseline)
892
Lives with a romantic partner >= 6 months
893
Patients must not be scheduled to discontinue their TKI under medical supervision within the next 3 months
894
Treatment of a thromboembolic event =< 6 months prior to randomization
895
A current resident of either King, Snohomish or Pierce counties in Washington State with the intent of remaining a resident for at least 3 months following study enrollment
896
Men recently treated (within 3 months) with radical prostatectomy or radiation
897
Plan to stay in the study area for 3 months
898
ONCOLOGIST: Planning to leave their current practice setting for other employment in the next 3 months
899
ONCOLOGY NURSE: Planning to leave their current practice setting for other employment in the next 3 months
900
PATIENT: Be those whose attending medical oncologist would not be surprised if the patient died in the next 12 months
901
2 months post treatment
902
Expected duration of ADT at least 12 months from date of study consent
903
First dose of LHRH agonist or antagonist no more than 6 months prior to date of study content
904
Active malignancies within 12 months with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome.
905
Pelvic radiotherapy administered within less than 6 months prior to enrollment. Subjects who received radiotherapy ? 6 months prior to enrollment must demonstrate no cystoscopic evidence or symptoms of radiation cystitis.
906
History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction within 6 months prior to Day 1 of Cycle 1
907
Expected survival of at least 4 months
908
Gastrointestinal perforation or fistulae within 6 months prior to randomization.
909
Prior use of probiotics within 3 months prior to enrollment
910
Prior use of acupuncture for CIPN within 6 months prior to study entry
911
Patient and caregiver: A history of a psychiatric illness unrelated to the HSCT within the past 18 months
912
Patients who have smoked within the last 6 months, since smoking may interfere with relaxation and breathing
913
Patients who currently practice yoga or have taken a yoga class regularly within the last 6 months
914
Hospitalized for psychiatric reasons within the past 3 months
915
Active yoga practice within the past 6 months
916
History of active opioid abuse within the past 12 months
917
History of active opioid abuse within the past 12 months
918
Minocycline trial only: patients who have had prior treatment for pancreatic cancer within the past six months may be excluded at the discretion of the investigator
919
Grade >= 3 thrombocytopenia (platelets < 50 x 10^9/L) after the first 3 months of therapy with the TKI for patients with CML and platelets < 100 x 10^9/L for patients with MF after the first 3 months of therapy; thrombocytopenia must be either recurrent (i.e., second or greater episode of thrombocytopenia) or having required dose reductions of the TKI
920
Subject is anticipated to have therapy with TKI continued for >= 3 months
921
Vaginal dryness or dyspareunia must be present for at least two months prior to study entry
922
No prior history of bisphosphonate or denosumab use in the past 12 months
923
No history of skeletal related events (SRE) within past 3 months\r\n* Excruciating bone pain requiring radiation therapy (RT)\r\n* Cord compression\r\n* Hypercalcemia (serum calcium > 10.5) \r\n* Pathologic fracture
924
At least 3 months into the maintenance phase, with at least 6 months left of\n             maintenance therapy
925
Any woman currently pregnant will not be eligible, but may participate 3 or more\n             months after the end of her pregnancy if the study is still ongoing
926
If survival is deemed less than 6 months for any medical condition
927
Have a stable partner for six months who is willing to participate
928
Patient with bilateral manipulation of axilla within the last 24 months
929
Active or recent pancreatitis (within last 6 months)
930
Treatment with any neuropathic agent including taxane, platinum, vinca alkaloid, or bortezomib chemotherapy in the past 6 months
931
Had sexual activity at least once in past 12 months (Randomized Trial Study only)
932
Has been in a stable sexual relationship of at least 6 months’ duration (Randomized Trial study only)
933
Women using systemic or vaginal estrogen, testosterone, or dehydroepiandrosterone (DHEA) in the 12 months preceding the Benchmark Survey Study will be excluded
934
Completed active cancer treatment other than maintenance therapy >= 3 months ago
935
Spouses and patients must be married or cohabiting and in intimate relationship for at least 6 months
936
Chronic opioid use for over 6 months
937
Anticipate moving from the region in the next 4 months
938
Patients engage in shift work or travel across more than three time zones within three months prior to study
939
The subject agrees to follow-up examinations out to 6 months post-treatment
940
Previous therapy with cetuximab within 6 months of consent
941
Treatment with high dose systemic corticosteroids or continuous use of other immunosuppressants within the past 6 months
942
Unwilling to refrain from donation of bodily fluid (blood, platelets, etc.) within 7 months of last vismodegib dose
943
Patients must have received a clinical diagnosis of lymphedema for at least 6 months and no more than 5 years; this timeframe allows ample time for any surgically related non-lymphedema swelling to subside by 6 months post-surgery, while a cap of 5 years will capture the broadest range of cases, and has been used as a timeframe in several studies including our pilot study
944
Treatment with any neuropathic agent including taxane, platinum, vinca alkaloid, or bortezomib chemotherapy in the past 6 months
945
Initiated therapy with either abiraterone plus a glucocorticoid or enzalutamide within the 3 months prior to randomization
946
Not previously engaged in regular exercise training (> 1-2 days/week [d/wk] for > 30 minutes/day [min/d]) in the past 6 months
947
Patients must have undergone an autologous transplant =< 12 months prior to allogeneic transplantation or have received multi-agent or immunosuppressive chemotherapy within 3 months of the preparative regimen
948
Less than 3 months from myeloablative conditioning for autologous transplantation
949
Use of venlafaxine or hypnosis in the past 6 months
950
Postmenopausal as defined by 1) no menstrual period in the past 12 months; 2) no menstrual period in the past 6 months and an FSH level greater than 40; or 3) women who have had a bilateral oophorectomy
951
Patients must not have had a screening mammogram within the last 11 months prior to date of randomization
952
Patients >= 65 years without underlying renal insufficiency get GFR tested within 6 months of the exam.
953
History of finasteride or dutasteride use in the last 6 months
954
Prior treatment with finasteride or dutasteride in the past 6 months
955
Patient must not have undergone breast ultrasound within 12 months prior to randomization
956
Plan to move outside of Miami-Dade county during the next six months
957
Patients who have no plans to move out of the region in the next 12 months
958
Have not had a clinician-provided digital rectal exam in the prior 3 months
959
Treatment or removal of HSIL less than 6 months prior to randomization
960
Prior history of documented DVT or PE in the past 3 months
961
Any of the following conditions:\r\n* Intracranial bleeding =< 6 months prior to randomization\r\n* Intraocular bleeding =< 6 months prior to randomization\r\n* Gastrointestinal bleeding and/or endoscopically proven ulcer =< 6 months prior to randomization\r\n* Head trauma or major trauma =< 1 month prior to randomization\r\n* Neurosurgery =< 2 weeks prior to randomization\r\n* Major surgery =< 1 week prior to randomization\r\n* Gross hematuria at the time of randomization
962
Use of any chemopreventive agents (selective estrogen receptor modulators [SERM]) in the last 3 months
963
Prior use of selective estrogen receptor modulators (SERMS) and aromatase inhibitors (AIs) for prevention or therapy, except for a maximum of 3 months and at least 12 months prior
964
Chronic, current or recent (within the past three months) use of leukotriene antagonists
965
History of autoimmunity that has not been controlled with treatment in the last 12 months
966
RECIPIENT: Experimental anti?CMV chemotherapy in the last 6 months
967
Subjects taking long-term systemic steroids defined as greater than 3 months in the past 12 months
968
Individuals with a history of diabetes, hypertension, or have smoked cigarettes in the last 12 months.
969
No cancer therapy in the prior 3 months (excluding chemoprevention agents)
970
Pregnant, or had given birth, or nursed at any time during the last 12 months
971
Willing and able to perform moderate intensity exercise at least 5 days per week for 6 months; this consists of a supervised exercise intervention at one of the 15 YMCAs affiliated with our program for 2 days per week; must be willing to perform unsupervised home exercise for the entire 6 months
972
Willing to participate in a weekly behavioral modification group phone call for first 3 months and every 2 weeks for the second 3 months
973
No actinic keratosis (AK)/Bowen’s disease in the treatment fields within the last 3 months
974
Not have gardened in the past 2 gardening seasons
975
Smoke >= 10 cigarettes per day for the last 6 months
976
Current enrollment or plans to enroll in another smoking cessation program in the next 9 months.
977
Willing and able to perform moderate intensity exercise at least 5 days per week for 3 months; this consists of a supervised exercise intervention at one of the 15 YMCAs affiliated with our program for 2 days per week for 8 weeks, then 1 day per week for 4 weeks; must also be willing to perform unsupervised home exercise for the entire 3 months
978
Willing to participate in a weekly behavioral modification group phone call for 3 months
979
Used smoking cessation medications within the past three months
980
Patients who are post-menopausal (defined as 12 consecutive months without a menstrual period)
981
Women with vasomotor symptoms with a uterus who are postmenopausal (no menstrual period for 12 months) or in late menopause transition (no period for 3 months and elevated follicle stimulating hormone [FSH])
982
Medications:\r\n* Current anticoagulant use (must discontinue for 3 weeks prior to fine needle aspirate [FNA])\r\n* Taking systemic hormones within two months (eight weeks) prior to screening RPFNA\r\n* Taken tamoxifen, raloxifene, or an aromatase inhibitor within the past 6 months\r\n* Participation on any chemoprevention trial within 6 months
983
Planning on remaining in New York City (NYC) for at least 9 months (with no vacations or trips to exceed two months)
984
Licensed taxi driver for at least 3 months
985
Will not be in the New York city (NYC) area for the duration of the study period (6-9 months)
986
Current enrollment or plans to enroll in another smoking cessation program in the next 6 months
987
Have had antibiotic therapy, probiotic supplements, or professional cleaning within the previous 3 months
988
Underwent screening or surveillance colonoscopy with removal of at least one adenoma within the last 9 months
989
Not currently taking aspirin (any dose) within the last 6 months
990
No immediate plans (within the next 3 months) to leave the city for vacation or for trips back to their home country
991
Interested in taking 3 months of varenicline
992
Agree to participate in this randomized smoking cessation trial with follow up assessments up to 12 months
993
Active psychosis or poorly controlled depression in the past 6 months
994
Any suicide attempt or poorly controlled depression in the past 6 months
995
Completion of chemotherapy or trastuzumab for > six months and of radiation therapy for >= 2 months, as applicable and 2 years or less from completion of standard therapy
996
Must be willing to have about 30 ml of blood drawn at 0, 6 and 12 months and about 5-10 ml of blood at 3 and 9 months
997
Participants must not have used any other investigation agent within the last six months
998
Patient has taken finasteride or dutasteride during the prior 6 months
999
Known plans to relocate or move from the Pittsburgh area within the coming 6 months;
1000
Received cessation treatment (including cessation counseling, NRT, bupropion, or varenicline) in past 2 months;
1001
Participation in more than 3 research studies in the past 6 months.
1002
Participation in a smoking study in the past 3 months.
1003
Current enrollment or plans to enroll in another smoking cessation program in the next 12 months
1004
Serious or unstable disease within the past 3 months
1005
History (last 3 months) of abnormal heart rhythms, cardiovascular disease (stroke, angina, heart attack) may result in ineligibility; these conditions will be evaluated on a case by case basis by the study physician
1006
Patient has had previous exposure to Folotyn within 6 months of study enrollment
1007
Willing to be followed-up for 6 months
1008
Planning to leave the college within next 6 months
1009
For Chantix:\r\n* Pregnant or breast feeding or planning to become pregnant in the next 6 months\r\n* Currently using nicotine replacement therapy (NRT)\r\n* History of suicide attempt in the past 12 months\r\n* History of thoughts of suicide in the past 12 months\r\n* History of thoughts of harming others in the past 12 months
1010
Patients with active eczema during the last 12 months
1011
Estimated probability of surviving less than 3 months
1012
Patients must have started on anastrozole and plan to continue on anastrozole therapy for a minimum of 12 months
1013
Participants must have a dental examination within 6 months of enrolling in the study
1014
Less than 3 months from myeloablative conditioning for autologous transplantation (if applicable)
1015
Will live in Nashville or surrounding area for the next 6 months
1016
Patients with ulcerative colitis in clinical remission (UCDAI) =< 1 for at least 3 months, regardless of how long ago they were diagnosed for UC
1017
Receiving maintenance therapy with mesalamine for at least 3 months
1018
Participants who have had any immunomodulatory treatment in the past 3 months will be excluded
1019
Not have gardened in the past 2 gardening seasons
1020
Used other smoking cessation medications within the past three months
1021
There has been a sufficient interval between a breast procedure and the RPFNA: at least 2 months for a prior RPFNA, at least 2 months for a core needle biopsy, at least 3 months for an excisional biopsy
1022
Have reasonable organ function as documented by complete blood count (CBC) and metabolic chemistry profile (within 3 months prior to study entry visit)
1023
Willing to have blood drawn at baseline and 12 months; if non-menstruating, an additional draw will be performed at approximately 11 months so as to predict when to perform the RPFNA
1024
Prior administration of anthracyclines is acceptable if therapy was completed > 6 months prior to study enrollment
1025
Use of tamoxifen, raloxifene, or chemotherapy within the previous 6 months
1026
Administration of any blood product within 3 months of enrollment
1027
Estimated probability of surviving less than 3 months
1028
Must be willing to have about 30 ml of blood (approximately 6 teaspoons) drawn at 0 and 3 months and about 5-10 ml of blood (approximately 1-2 teaspoons) at 1 and 2 months
1029
Proton pump inhibitor use at least once daily for at least twelve months prior to enrolment, and stable dose of PPI for the three months before enrolment
1030
Have no plans to move in the next six months
1031
Documentation of complete ablation of BE after radiofrequency ablation on two endoscopic examinations at least 3 months apart (including no evidence of BE on surveillance biopsies) as determined by the pathologist at each site; completion of ablation should have occurred no greater than 36 months prior to randomization
1032
Pregnancy in the last 6 months/planned within the next 2 years or currently lactating
1033
Sedentary (have not participated in a regular exercise program in the past 12 months)
1034
Nonsmokers (not smoking during previous 12 months)
1035
Male patients must agree not to donate sperm during the study and for 2 months after discontinuation of vismodegib
1036
Experimental immunotherapies: 3 months
1037
Vaccine based therapy: 3 months
1038
PSADT > 3 months and < 36 months\r\n* Calculated based at least 2 values that are post-treatment and > 0.2 in the prior 2 years with the first and last PSA separated by at least 3 months\r\n* Use all values in the last 2 years that are post-treatment and > 0.2 to calculate PSADT\r\n* PSADT calculated while NOT on androgen deprivation therapy (ADT)\r\n* If prior ADT use, then documented either A) normal testosterone or B) a testosterone within 50 points of normal and stable (defined as a second testosterone at least 6 weeks later that is equal or lower than the first testosterone) is required before starting to calculate PSADT
1039
Must have completed radiotherapy at least 12 months prior to entry
1040
Subject has coronary artery disease with an ischemic event within 6 months prior to enrollment.
1041
Vaccine-based and/or viral therapy: 3 months
1042
Treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis
1043
During the study and for 3 months after receiving the last dose of daratumumab, a woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction
1044
No change in menstrual patterns for the past 6 months preceding the time of registration
1045
Have received other investigational agents within the past 3 months (preceding the time of registration)
1046
Use of selective estrogen receptor modulators (SERMS) in the past 6 months, including tamoxifen and raloxifene
1047
Previous treatment with acupuncture in the last 12 months
1048
Participants must be able and willing to undergo a bronchoscopy before and after treatment for 6 months
1049
Subject is aged 6 months to 21 years inclusive.
1050
LHW: Live in the relevant area and intend to stay there for the next 12 months
1051
PARTICIPANTS: live in relevant area and intend to stay there for at least 12 months
1052
5 or more CPD for at least 6 out of past 12 months
1053
Current or recent (< 3 months) breastfeeding (females only)
1054
Current or planned pregnancy within the next three months (females only)
1055
Current smoker (> 5 cigarettes per day for the past 3 months)
1056
Agree to participate in the study and be available for 6 weeks of treatment and 6 months of follow-up
1057
Estimated survival of at least 6 months.
1058
Planning on changing diet or exercise behavior in the next 6 months
1059
History of CMV end-organ disease within 6 months before randomization
1060
Chronic, current or recent (within the past three months) use of leukotriene antagonists
1061
Chronic, current or recent (within the past three months) use of glucocorticoids (systemic, topical and/or nasal sprays)
1062
Patients with confirmed symptomatic PE and/or DVT who have been treated for 6 to 12 months and did not interrupt anticoagulation for longer than 1 week
1063
Interested in taking 3 months of varenicline
1064
New onset of chest pain or arrhythmia in the past 2 months
1065
has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
1066
Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo.
1067
Occurrence of a varicella or HZ episode by clinical history within the 12 months preceding the first dose of study vaccine/placebo.
1068
has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
1069
Must have pathologically confirmed squamous metaplasia or squamous dysplasia documented by autofluorescence bronchoscopy within the preceding 60 months
1070
Must be willing to attend all scheduled study visits, complete all study questionnaires, and allow biological specimen collection including a bronchoscopy within 3-4 months after enrollment into the study
1071
heart attack, acute (2 days) cardiac event or stroke in preceding six months,
1072
As per patient report or as confirmed by the medical record, if the patient is taking anti-depression or anti-anxiety medication, < 2 months on these medications or a change in the prescribed dose in the past 2 months
1073
For healthy volunteers only: Must have no known medical problems that would make undergoing the scan hazardous to the health of the patient or interfere with the results. In particular subjects should not have any cardiac or immunological disorders as these would likely affect the scan results. Subjects should have had a full physical exam within 6 months of the study. If healthy volunteers have not had a full medical exam within 6 months of the study, one of the nuclear medicine physicians will conduct the medical exam prior to any study procedures.
1074
Daratumumab or other anti CD38 antibody treatment within 3 months prior to study enrollment
1075
For traditional cigarettes (TC) smokers, daily TC smoking in the past 6 months, at least 10 cigarettes per day, with no EC exposure in the past 6 months
1076
For electronic cigarettes (EC) users, daily EC use in the past 6 months, at least 10 sessions per day, with no TC exposure in the past 6 months
1077
Locoregional treatment of hepatocellular carcinoma within the prior 3 months or chemotherapy within the previous 3 months
1078
No anti-estrogen therapy for desmoid tumor within the past 6 months
1079
Patient received a permanent prostate brachytherapy implant within the last 3 months (for palladium [Pd]-103 implants) or 12 months (for iodine [I]-125 implants)
1080
Acute prostatitis within the last 6 months
1081
More than 6 MET PET scans within the previous 12 months
1082
History of taken antibiotics in the previous 3 months
1083
Prostatectomy at M. D. Anderson within 3 months from the time of MRSI
1084
Year 3 visit can not exceed 3 years and 6 months from the baseline visit
1085
HEALTHY VOLUNTEERS: Must have no known medical problems and have had a full medical exam within 6 months of the study; if healthy volunteers have not had a full medical exam within 6 months of the study, one of the ultrasound physicians will conduct the medical exam prior to any study procedures
1086
Presently planned for ongoing octreotide according to current standard of care for at least 12 months (i.e. throughout the study follow-up period)
1087
Expected lifespan less than 12 months by investigator assessment
1088
LOCALIZED RCC TREATED WITH PARTIAL NEPHRECTOMY:\r\nExpected survival of at least 3 months
1089
ADVANCED RCC TREATED WITH RADICAL NEPHRECTOMY:\r\nExpected survival of at least 3 months
1090
Radiotherapy to the abdomen or pelvis within 6 months of the screening visit
1091
Stroke or TIA within 12 last months
1092
the use of the copper-releasing intrauterine device (to have been in place for at least 2 months prior to screening)
1093
At least 4 months after HCT, either autologous or allogeneic (of any source, with any preparatory regimen, for any indication), prior to study treatment.
1094
Subject is < 2 months from the start of the last cycle of consolidation and should have completed the recommended number of consolidations per local practice.
1095
Androgen deprivation therapy (ADT) in the past 3 months
1096
Documented normal LVEF for at least 6 months after the initiation of recommended HF therapy
1097
Subject has received a Feraheme® (ferumoxytol) Injection within the past 6 months.
1098
Known history of ablative or excisional therapy to the cervix within the preceding 12 months.
1099
Prior exposure to cisplatin, 5-fluorouracil, tamoxifen, and/or MEK inhibitors within 3 months of enrollment and/or ethambutol and/or hydroxychloroquine within 12 months.
1100
Not interested in quitting smoking in the next 6 months
1101
Antibiotic use within 2 months of study enrollment or during the study by self-report
1102
Major changes in eating habits within the past 3 months
1103
Must have no known medical problems and have had a full medical exam within 6 months of the study
1104
No international travel planned during the next 4 months
1105
Postmenopausal (no menstrual cycle in the past 12 months)
1106
Planned quit date within the next two months
1107
Willing to maintain contact with the investigators for 12 months
1108
Expected survival > 6 months
1109
Antibiotic use within 2 months of study enrollment by self-report
1110
Symptomatic coronary artery disease currently or within the past 6 months,
1111
PATIENTS: A prognosis of 12 months or less based on the treating oncologist’s assessment
1112
Patients with electronic health record (EHR)-documented colonoscopy in the past 10 years, sigmoidoscopy in the past 5 years, or fecal occult blood test (FOBT) or fecal immunochemical test (FIT) in the past 12 months will be excluded
1113
Planning on remaining in NYC for at least 1 year, (with no vacations or trips to exceed two months)
1114
Licensed taxi driver for at least three months
1115
Have resided (and intend to continue to reside) in the same home as the child/ren for the past 6 months (and the next 6 months)
1116
Recruit for at least 9 months at the point of enrollment
1117
Interested in trying to quit in the next 3 months
1118
Due for CRC screening:\r\n* No colonoscopy within the prior 10 years\r\n* No flexible sigmoidoscopy within the prior 5 years\r\n* No fecal blood testing (FOBT or FIT) within the prior 12 months
1119
Exclude patients who have a FOBT or colonoscopy scheduled within the last six months
1120
A referring physicians estimate of patient life expectancy must be between 1-12 months
1121
Patients must have completed all therapy for curative intent at least six months prior to chart audit
1122
Occurrence of heart attack, stroke, or angina in the past 3 months
1123
Known plans to relocate or move from the Pittsburgh area within the coming 3 months
1124
Active plans to leave the country in the next 3.5 months
1125
Participation in more than 3 research studies in the past 6 months. Participation in a smoking study in the past 6 months. Participation in a study which involved medication within the last month
1126
Expected survival longer than 3 months from enrollment in the study.
1127
Expected survival of at least 3 months from the date of enrollment in the study.
1128
Patients are eligible if they have been in stable dasatinib induced CMR for a minimum of nine months, documented by at least three assessments, conducted 2 - 6.5 months apart, at a local lab.
1129
Male sterilization (at least 6 months prior to enrolling). For female patients on the study the vasectomized male partner should be the sole partner for that patient.
1130
Disease progression within 12 months prior to study enrollment.
1131
no recent (past 3 months) cardiovascular trauma: MI, stroke
1132
Patient is willing and able to undergo standard of care imaging studies (same\n             imaging/staging modality being used at each evaluation), which are anticipated to be\n             performed prior to the initiation of therapy and subsequently every 3 months.
1133
Subsequently at 1, 2, 3 and 12 months after the initiation of therapy, and/or;
1134
Disease progression or recurrence less than or equal to 12 months of prior autologous SCT
1135
Expected survival of more than 6 months.
1136
Participants must show evidence of disease progression within 12 months (an additional month will be allowed to accommodate actual dates of performance of screening scans, ie, within ?13 months) prior to signing informed consent, according to RECIST 1.1 assessed and confirmed by central radiographic review of CT and/or MRI scans.
1137
One or more measurable lesions that have progressed according to RECIST 1.1 within 12 months (an additional month will be allowed to accommodate actual dates of performance of screening scans, ie, within ?13 months) after Iodine-131 therapy, despite demonstration of radioiodine avidity at the time of that treatment by pre- or posttreatment scanning. These participants must not be eligible for possible curative surgery.
1138
Cumulative activity of Iodine-131 of >600 mCi or 22 gigabecquerels (GBq), with the last dose administered at least 6 months prior to study entry.
1139
History of peptic ulcer disease or erosive gastritis within the past 6 months, unless treated for the condition and complete resolution has been documented by esophagogastroduodenoscopy (EGD) within 28 days of starting study treatment
1140
Expected survival of at least 12 weeks after dosing.