Opportunistic infection within the last 3 months
Have an expected survival of ?3 months.
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
History of arterial thrombotic or embolic events (within 6 months prior to study entry)
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.
Hemoptysis (> ½ teaspoon [2.5 mL] of bright red blood) within 6 months prior to randomization
Peptic ulcer within the past 3 months prior to randomization, unless treated for the condition and complete resolution has been documented by esophagogastroduodenoscopy (EGD)
Ipsilateral diagnostic mammogram within 12 months of enrollment
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
Mammographic finding of BIRADS 4 or greater within 6 months of registration at site other than that of known DCIS, without pathologic assessment
History of hospitalization in past 12 months for diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic nonketotic syndrome (HHNS)
Patients must not have had hemoptysis of >= 0.5 teaspoon (2.5 ml) of red blood within 3 months prior registration
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
NO hepatic artery embolization or cryoablation/radiofrequency ablation of hepatic metastasis within 2 months of study treatment start
No prior taxane therapy =< 6 months, except as a radiosensitizer
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)
History of bleeding esophageal varices in previous 6 months, which have not been adequately managed with banding or sclerotherapy.
History of peptic ulcer disease within 3 months of treatment.
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);
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);
Subjects must be age >12 months at enrollment
Symptomatic bowel obstruction within 6 months prior to screening visit
Systemic treatment with interferon (IFN)-? within the previous 6 months.
Unstable angina pectoris </=6 months prior to enrollment
History of gastrointestinal perforation and/or fistulae within 6 months prior to initiation of study treatment;
Expected survival >= 3 months after consenting
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
Prior treatment with docetaxel within 6 months of study enrollment
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.
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.
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
Recurrence of BCG unresponsive Ta/T1 disease > 6 months after last BCG instillation or BCG unresponsive CIS > 12 months after last BCG instillation.
Unstable angina within 6 months prior to study entry,
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
Life expectancy of > 3 months as defined by agreement of both the Chow et al. and TEACHH models
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);
Hospitalization for bowel obstruction within 3 months prior to enrollment
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
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
Seizures within the past 12 months before enrollment
Must have an expected survival of at least three months.
Grade ?2 ventricular arrhythmia ?6 months prior to Day 1
Patients must be within 12 months of initiation of induction therapy and must have had not more than 2 prior induction regimens
Prior carboplatin allowed provided greater than 12 months (mos) have elapsed since last dose of carboplatin
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)
Active malignancies within 12 months with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
Ongoing therapy with nonsteroidal anti-inflammatory drugs for more than 2 months.
History of any arterial thrombotic event within 6 months prior to enrollment.
Agree not to donate sperm until 6 months after the last dose of OPN-305
At least 4 months since completion of curative therapy, if given previously
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
History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
PIK3CA WILD TYPE COHORT (closed 03/17/2016): Life expectancy > 4 months
Syncope without known aetiology within 3 months
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
Expected survival of ? 12 weeks.
Has been on any hormonal treatment (including progestin-containing intrauterine device [IUD]) for CAH/EIN or grade 1 endometrial carcinoma in last 3 months
Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy
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.
Life expectance of >= 3 months
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.
Chronic bronchitis or emphysema requiring oxygen therapy within the last 6 months
History of gastrointestinal perforation and/or fistulae within 6 months prior to enrollment
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
Duration of prior HMA therapy ? 9 months and/or total ? 9 cycles of prior HMA therapy in ? 12 months
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
New onset seizures (within 3 months before planned randomization) or poorly controlled seizures
Failed prior alloSCT within the past 6 months from Cycle 1 Day 1
Platelets ? 100,000/microliter independent of transfusion and/or growth factors within 3 months prior to randomization
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 .
Patients with prior history of a thromboembolic event within the last 12 months that is not being treated with systemic anticoagulation are excluded
Splenic irradiation within the last 6 months
History or evidence of thrombotic or hemorrhagic disorders within 6 months before first study treatment
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.
PSA doubling time of < 6 months, measured over the 3 months prior to enrollment
Received PDT during the past 3 months
Prior treatment with clofarabine within 6 months or history of clofarabine-induced liver dysfunction
Previous androgen deprivation therapy lasting more than 6 months
alemtuzumab within 6 months of enrollment
fludarabine, cladribine, or clofarabine within 3 months of enrollment
Presence of active lymphoma or active PTLD, based on imaging performed within the previous 3 months.
Anticipated survival minimum of 12 months.
Prior regimen within 6 months
Prior regimen must be within 6 months of registration
Disease has progressed through at least one systemic therapy or through local irradiation within the preceding 6 months.
Prior Red blood cell (RBC) transfusion < 3 months prior to starting CC-90002.
Exposure to household contacts =< 15 months old or household contact with known immunodeficiency
Treatment with the modified Atkins diet (MAD) for any cause within the 9 months prior to study enrollment
Previous or concurrent treatment with selective estrogen receptor modulator (SERM) and/or hormonal replacement therapy within 3 months of the study
At least 3 months has elapsed from the time of transplant and
Patient is more than 6 months since the last dose of FOLFIRI
COHORT B, GROUP 6: HEPATOCELLULAR CARCINOMA: Ascites that is not medically controlled or that required a therapeutic paracentesis within last 3 months
COHORT B, GROUP 6: HEPATOCELLULAR CARCINOMA: Any episode of hepatic encephalopathy within the previous 6 months
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
Expected survival of at least 3 months.
unstable angina (anginal symptoms at rest) or new onset angina (i.e., began within the last 3 months).
Normal mammogram of unaffected breast within 12 months prior to study entry
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
Any prior myeloablative transplant within the last 6 months
History or evidence of thrombotic disorders within 6 months before first study treatment unless stable on anticoagulation for > 3 months
> 1 hospital admission for infection in prior 6 months
Anticipated survival of < 3 months
Agree to be evaluated at the transplant center or by local provider every 3 months for 12 months after randomization
Presence of any other medical complication that implies survival of less than six months
Patients with Allo-SCT on active GVHD or immunosuppression therapy within 3 months prior to C1D1.
Started antiandrogen therapy (ADT) no longer than 6 months prior to randomization
Current use of statins or fibrates for any time during the 3 months prior to the study
Prior treatment with immunotherapy (e.g. ipilimumab, nivolumab, pembrolizumab, atezolizumab) within 6 months of cycle 1 day 1
Subjects with arterial thrombotic events in the prior 12 months (axitinib has never been studied in this population)
Subjects who have had venous thrombotic events in the prior 6 months (axitinib has never been studied in this population)
Men who intend to father children during the study or within 4 months afterward are excluded
Carboplatin or paclitaxel exposure within past 6 months.
History of coronary or vascular stent placed within the past 3 months (may be extended to 1 year if medically indicated per physician discretion).
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
For known primary, disease-specific graded prognostic assessment (ds-GPA) estimated median survival no less than 6 months
For unknown primary, graded prognostic assessment (GPA) estimated median survival no less than 6 months
Patients who have a known primary and have an estimated median survival less than 6 months per ds-GPA
Patients who have an unknown primary and have an estimated median survival less than 6 months per GPA
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)
Less than 6 months from the completion of last trastuzumab infusion
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.
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.
No recent (=< 3 months) of partial or complete bowel obstruction unless surgically corrected
Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis
Hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy
Age ? 55 years with no menses for 12 or more months without an alternative medical cause AND an FSH level > 40 IU/L; or
Last dose of anticancer therapy must have been administered within 6 months of the date of randomization into this study.
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
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
Radiotherapy to a target lesion within the past 3 months prior to baseline imaging unless that area has demonstrated progression
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
Other malignancies requiring active treatment in the last 6 months
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.
Aged at least 2 months and less than 18-years-old on Day 1 AND
> 1 hospital admission for infection in prior 6 months
Anticipated survival of < 3 months
Have active disease, with at least 2 documented porphyria attacks within the last 6 months
Internal jugular venous thrombosis, acute or within 3 months.
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.
Expected survival > 3 months from study enrollment
Have expected survival of at least 4 months
Life expectancy of > 12 months (exclusive of the disease for which the auto HSCT is being performed)
History of acute urinary retention within 6 months of study entry;
Clinical symptoms (e.g., dyspnea or cough) consistent with BOS of ? 2 months duration
Patients must have life-expectancies > 6 months to be included in the trial
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
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
Expected survival ? 3 months
T cell-directed antibody therapy (eg. Alemtuzumab, anti-thymocyte globulin) within 6 months of enrollment
Experienced at least 1 VOC within the preceding 12 months prior to Screening, as determined by medical history.
If receiving HU/HC or erythropoietin stimulating agent, must have been receiving the drug for at least 6 months prior to Screening
Subjects must have progression within 6 months of platin exposure during definitive or palliative therapy.
Subjects willing to participate in the study for at least 8 months
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
>= grade 3 thromboembolic event in the last 6 months
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
Estimated survival >= 3 months
Documented history of capillary leak syndrome within 6 months of study enrollment.
Expected survival must be greater than three months
Participants with a serious medical illness that may limit survival to less than 3 months
Must have had a diagnostic mammogram performed within the last 6 months
Expected survival > 6 months
Myocardial infraction (MI) within the previous 6 months
Participants with a history of variceal bleed within 6 months prior to enrollment
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
Syncopal episode within 12 months of screening
Pulmonary embolism (PE) in the 3 months before enrollment; anticoagulation is permitted as long as stable dosage for more than 3 months
alemtuzumab within 6 months of enrollment
fludarabine, cladribine, or clofarabine within 3 months of enrollment
Life expectancy < 6 months (as estimated per diagnosis-specific graded prognostic assessment [ds-GPA])
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
History of any arterial thromboembolic event within 3 months prior to first dose of investigational product
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.
Has history of wound dehiscence or complications requiring medical intervention within 6 months of study entry
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
Exposure to household contacts =< 15 months old or household contact with known immunodeficiency
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)
History or evidence of thrombotic or hemorrhagic disorders within 6 months before first study treatment
Patients must have completed at least 2 months of their current endocrine therapy prior to registration
Any episode of atrial fibrillation in the prior 12 months.
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;
Previous intravesical therapy within 6 months of study entry.
Myocardial Infraction (MI) within the previous 6 months
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
Age ? 55 years with no menses for 12 or more months without an alternative medical cause AND an FSH level > 40 IU/L; or
Have expected survival of at least 4 months
No known Food and Drug Administration (FDA) -approved therapy available that is expected to prolong survival by greater than 3 months
>= 2 months since last therapy for HSIL
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
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
Participants have had at least 1 episode of vaso-occlusive crisis (VOC) in the past 12 months.
For participants taking hydroxyurea (HU), the dose of HU (mg/kg) must be stable for at least 3 months prior to signing the ICF.
More than 10 VOCs within the past 12 months that required a hospital, emergency room or clinic visit
Patients with life expectancy of =< 6 months for reasons other than their underlying hematologic/oncologic disorder
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
Anticipated survival of at least 3 months
Expected survival < 2 months
Treatment with alemtuzumab within 6 months of leukapheresis or fludarabine or cladribine within 3 months of leukapheresis
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
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.
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
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;
Subject has an ECOG Performance Status 0-1 and anticipated life expectancy >6 months prior to apheresis and >3 months prior to lymphodepletion.
Current thrombotic or hemorrhagic disorder/event or history of prior event within 6 months of start of screening
Baseline skin biopsy taken within 6 months available for central review submission
GNRH agonists or GNRH antagonists (e.g., leuprorelin, degarelix) for > 2 months prior to consenting
Estrogen containing compounds for > 2 months prior to enrollment
Prior allo-HCT less than three months from the time of enrollment
Documented fungal infection within 3 months of BMT
History of syncope within the last 6 months
Previous stroke < 12 months
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
No active alcohol addiction (as assessed by medical caregiver and defined as at least 6 months without activity)
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
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
Has had encephalopathy in the last 6 months; subjects on rifaximin or lactulose to control their encephalopathy are not allowed
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)
Expected survival of at least 3 years
Predicted survival of > 6 months
Previous extensive radiotherapy to the lung or liver during the last 4 months prior to lymphodepletion regimen.
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
Previous radiotherapy within 3 months before study entry
No treatment with paclitaxel or nab-paclitaxel within 4 months prior to initiation of study therapy
Treatment with alemtuzumab or other T cell-depleting antibodies within 6 months of T cell therapy
Platelet count of >= 100 k/mL independent of transfusion and/or growth factors within 3 months prior to randomization
History of central nervous system bleeding as defined by stroke or intraocular bleed within 6 months of enrollment.
Taxane therapy within the past 3 months (90 days) prior to study day 1
New onset seizures (within 3 months prior to screening) or poorly controlled seizures
Prior pancreatitis that was symptomatic or required medical intervention =< 6 months prior to registration (known toxicity of pembrolizumab)
Prior enteritis that was symptomatic or required medical intervention =< 6 months prior to registration (known toxicity of pembrolizumab)
Uncontrolled hyper/hypothyroidism or hyper/hypocorticism =< 6 months prior to registration (known toxicity of pembrolizumab)
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
The patient has a history of GI perforation and/or fistulae within 6 months prior to enrollment
Less than 3 months since prior myeloablative transplant
Have failed prior treatment within 6 months of consent date
Prior conventional irradiation of the spine site and level to be treated with an interval shorter than 3 months
Expected survival ? 6 months.
History of arterial thrombosis within 3 months of starting study treatment
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
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
Must be >= 3 months after prior myeloablative transplant, if applicable
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
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
Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months)
Expected survival must be greater than 3 months
Receipt of sunitinib within 3 months of receiving tremelimumab
History of arterial thromboembolic events in the past 3 months and of venous thromboembolic events in the past month
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.
Patients with life expectancy of =< 6 months for reasons other than their underlying hematologic/oncologic disorder
Expected survival of more than 12 weeks;
For hypomethylating failure cohorts only, more than 4 months since last cycle of HMA
Previous history of haemoptysis (expectoration of more than 2.5 mL of blood), within three months prior to enrollment
Arterial or venous thromboembolic events within 6 months of study enrollment
Within 3 months of registration: Serum potassium >= 3.5 mmol/L
That has progressed within 6 months prior to study enrollment (Cohort 5 Expansion and Cohort 6 ONLY)
Vaccinations initiated between 3 weeks and 3 months from completion of SoC multi-modality cancer care
Disease-free interval =< 30 months
Patients with an estimated survival of less than three months.
Expected survival > 3 months
Prior GEM therapy is acceptable as long as the last dose was >= 3 months from registration on this study
Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting study drugs
Male patients must agree not to donate sperm during the study and for 2 months after discontinuation of vismodegib
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.
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
Recent documented myocarditis within 2 months of consent
Trastuzumab treatment within the last 3 months
Postmenopausal with last natural menses > 24 months prior
Has a history of an arterial thromboembolic event within the prior six months including CVA, TIA, MI, or unstable angina
Syncopal episode within 12 months of screening
History of HIV-associated encephalopathy; dementia of any kind; seizures in the past 12 months
Anticipated survival of at least 6 months
Radiotherapy to the target lesion within the past 3 months prior to baseline imaging
Patients with a life expectancy of < 6 months as predicted by the Adult Comorbidity Index (ACE-27)
Current enrollment or plans to enroll in another smoking cessation program in the next 12 months
Serious or unstable disease within the past 3 months
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
Patient with stroke in the last 3 months
Patients with a history of seizures with in the past 3 months
Must have an expected survival status of at least 3 months
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
Had eculizumab therapy within three months prior to screening
Syncopal episode within 12 months of screening
History or signs of active coronary artery disease with angina pectoris within the last 6 months.
COHORT II: At the time of enrollment, patients must have had bilateral mammograms within 6 months
Expected survival > 3 months
Prior radiotherapy to doses >= 45 Gy to the area of recurrence, >= 6 months prior to enrollment
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)
An interval of >= 2 months since completion of fractionated radiotherapy
Cytarabine containing regimen in excess of 2 g/m^2/day within 6 months of study entry
Prior autologous SCT in last 12 months
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
Exposure to household contacts =< 15 months old or household contact with known immunodeficiency
Patients ineligible if the time interval between radical prostatectomy and the first day of randomization exceeds 3 months (+/- 2 weeks)
Treatment with androgens within 6 months prior to study enrollment
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
Expected survival > 12 weeks
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
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)
Previous hospitalization due to documented heart failure in the last 12 months
Expected survival > 2 months
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
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
Prior exposure to thiazolidinedione (TZD) therapy in the past 12 months
No prior allogeneic HCT, and no autologous HCT within the previous 12 months
Estimated survival of at least 3 months
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.
History of treatment with canakinumab within the 12 months prior to study initiation
Unstable angina pectoris < 6 months prior to screening
Acute symptomatic pancreatitis within 6 months of study entry or a diagnosis of chronic pancreatitis at the time of randomization.
Expected survival > 3 months
Patients with life expectancy of =< 6 months for reasons other than their underlying hematologic/oncologic disorder
Patients must have received the current TKI for at least 18 months and not have increased their dose in the last 6 months.
An anticipated overall survival of at least 6 months
Prior exposure to CMC-544 within past 6 months
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Use of systemic antibiotics in 12 months preceding baseline sampling
Prior allogeneic hematopoietic SCT within the last 12 months or reduced-intensity transplant within the past 6 months
Anticipated patient survival under 3 months
Documented cerebral infarction within past 12 months
At least 2 months from completion of temozolomide (to be consistent with the “rechallenge” group from Perry et al. JCO 2010)
A prior history of Gliadel implantation in the past six months
Patients are eligible to start on this protocol if they are between 6 months to 10 months post transplant
Life expectancy of greater than 2 months to allow completion of study treatment and assessment of dose-limiting toxicity
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.
Unstable angina within 6 months prior to first dose;
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.
Recent (< 12 months) active diverticulitis
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
Patients with life expectancy of =< 6 months for reasons other than their underlying hematologic/oncologic disorder
Patients with life expectancy of =< 6 months for reasons other than their underlying hematologic/oncologic disorder
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
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
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
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
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
MLL rearranged AND age > 6 months
MLL rearranged AND age < 6 months AND WBC < 300 x 10^9/L AND prednisone good response
Age at diagnosis < 6 months (i.e., < 183 days)
Myeloablative transplant within the last 6 months
If > 18 years old, prior myeloablative transplant within the last 6 months
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
Second BMT: must be >= 3 months after prior myeloablative transplant
Transfusion dependent anemia with transfusion dependency of ?3 months
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)
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
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
History of at least one documented blood transfusion within 6 months of enrollment
Chronic ITP (ITP lasting for greator than or equal to ([>=] 12 months) as defined in the protocol
Unstable angina within 6 months prior to study entry
Clinically stable in NYHA class 2 or 3 for the 3 months preceding screening
Use of GSK2315698 (CPHPC), or participation in a separate clinical trial involving CPHPC within 3 months of screening
Patients must have a reasonable expectation of ? 6 months survival
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.
Prior focal radiotherapy within 3 months of screening.
Expected survival ? 6 months.
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;
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.
Expected survival > 6 months.
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
Colonoscopy(or CT colonogram(within 16 months prior to randomization)
Having plans to leave the immediate geographical area within 9 months.
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.
History of chronic steroid use within the past 6 months
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.
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
Currently taking ibrutinib and first took ibrutinib > 3 months ago
Estimated survival ? 6 months.
Fludarabine based therapy within 6 months of enrollment
Expected survival ? 6 months
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.
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
Recent arterial thromboembolic event within the previous 6 months
Platelets ? 100,000/microliter without transfusion and/or growth factors in the 3 months prior to randomization
Expected survival ? 3 months in the view of the PI or investigators
Expected survival of greater than 16 weeks.
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
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
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.
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
Documented myocarditis within 2 months of enrollment
Trastuzumab treatment within the last 3 months
Anticipated survival of at least 3 months
May not have prior malignancies unless the expected survival is at least 2 years
History of cardiovascular disease (e.g., myocardial infraction [MI], thrombotic or thromboembolic event in the last 6 months)
Patient had last menstrual period within the last 12 months or
Group 3 - patients must have pathologically documented, definitively diagnosed advanced MTC that has progressed within 14 months prior to the Screening Visit.
PRRT administered within 6 months of the first dose.
Patients with TE event occurring > 6 months prior to enrollment and receiving active anticoagulation
Active intravenous (IV) bisphosphonate use in the last 3 months
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
Current exposure to household contacts =< 15 months old or household contact with known immunodeficiency
Willing to avoid household contacts =< 15 months old or household contact with known immunodeficiency 1 week after treatment
Exposure to household contacts =< 15 months old or household contact with a person with known immunodeficiency
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
Subjects must not have had prior androgen deprivation therapy in the past 6 months
History of androgen deprivation therapy within the past 6 months
Expected survival >= 3 months
Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting study drugs
Stable, continuous antiretroviral treatment for at least three months before enrollment, defined as a multi-drug regimen (excluding azidothymidine [AZT])
New onset seizures (within 3 months prior to the first dose of rigosertib) or poorly controlled seizures.
History of thromboembolic episodes =< 3 months prior to registration
Exposure to household contacts =< 15 months old or household contact with known immunodeficiency
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
Expected survival > 3months
Be postmenopausal (defined as amenorrheic for at least 12 months)
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
Anticipated patient survival under 3 months
Must be >= 3 months after prior myeloablative transplant, if applicable
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
Transplant < 4 months prior to study enrollment
Any history of HIV-associated encephalopathy; dementia of any kind; seizures in the past 12 months
Angina pectoris =< 12 months prior to starting drug
Participants must be hepatitis C negative =< 6 months prior to screening
Expected survival > 3 months
Patients must have a complete cytogenetic response (CCyR) OR must have been on nilotinib for a minimum of six months
History of acute pancreatitis within 12 months prior to screening
Receiving mitotane within 6 months of enrolling on the study
Tamoxifen or other preventive measures within 6 months
History of cerebro-vascular accident within 6 months of enrollment
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
Expected survival < 2 months
Never treated with cytoreductive drugs except hydroxyurea for up to 3 months maximum (phlebotomy, aspirin allowed, anagrelide allowed)
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
Pretransplant treatment with sorafenib tosylate (sorafenib) not > 12 months (not exceeding 12 months of treatment, total)
Subject must be at least 2 months (from first dose of lenalidomide) from stem cell infusion.
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.
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.
Disease progression during or after the last treatment regimen and within 6 months before study entry.
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
Females must abstain from breastfeeding during study participation and 3 months after IP discontinuation.
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
Previous anti-angiogenics or anti-vascular endothelial growth factor within 12 months of registration
Patient must have expected survival of ?3 months
Any BM relapse after allogeneic SCT and must be > 6 months from SCT at the time of CTL019 infusion OR
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
Have experienced a Grade ?3 bleeding event within 3 months (?3 months) prior to randomization.
Life expectance of greater than two months to allow completion of study treatment and assessment of dose-limiting toxicity
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.;
At least 6 months since prior treatment with curative intent and recurrence
Splenic irradiation within 12 months prior to screening, or prior splenectomy.
< 6 months between completion of prior RT and initiation of reirradiation using proton therapy
History of intracranial abscess within 6 months prior to study enrolment.
Documented clinical prostatitis requiring therapy within 6 months prior to Treatment
History of acute urinary retention within the last 12 months
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
History of hemoptysis of ? 2.5 mL/1 teaspoon within 6 months of Cycle 1 Day 1
Active bowel obstruction, or hospitalization for bowel obstruction within 2 months prior to screening
Diagnosis of malignant disease within the previous 12 months
Active GI bleeding, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy
Other investigational mAbs within 6 months prior to first dose of IP.
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
At least 2 months must have elapsed from the use of tamoxifen
At least 6 months must have elapsed from the use of fulvestrant
Fludarabine or Campath within 12 months prior to study entry
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
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
Males must agree to take appropriate precautions to avoid fathering a child from screening until 3 months after their last dose of study medication
Treated with eculizumab for PNH for at least 6 months prior to Day 1
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)
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
unstable angina (angina symptoms at rest) within less than or equal to 3 months prior to randomization; and
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.
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.)
No unstable angina pectoris < 6 months
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)
Have stable renal function without dialysis for at least 2 months prior to Investigational Product (IP) administration defined by:
Previous treatment with Samarium-153, Strontium-89, Rhenium-186 or Radium-223 within 6 months of starting (i.e., Cycle 1 Day 1) EC1169
The subject has had a hypoglycemic episode requiring medical intervention while on insulin (or other anti-diabetic) treatment within 12 months before Day 1.
New onset seizures (within 3 months prior to Screening) or poorly controlled seizures.
Prior liver resection must have taken >2 months prior to randomization
Expected survival of at least 6 months
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
Immunotherapy within 6 months of C1D1
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).
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
have experienced any arterial thromboembolic event within 6 months prior to enrollment
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
have a history of GI perforation and/or fistulae within 6 months prior to enrollment
Anticipated lifespan greater than 3 months
Have a history of gastrointestinal perforation and/or fistulae within 6 months prior to randomization.
Has had encephalopathy in the last 6 months. Participants on rifaximin or lactulose to control their encephalopathy are not allowed
Has symptoms of bowel obstruction in the past 3 months
Stroke or other symptoms of cerebral vascular insufficiency within the last 3 months.
Evidence or history of thromboembolic, venous, or arterial events within the past 3 months
Subjects with active HBV infection need to be on anti-HBV suppression ?3 months, throughout treatment and for 6 months after
disease recurrence either must occur within 12 months of the most recent intravesical therapy of any kind, OR
disease recurrence within 18 months of BCG maintenance OR
disease recurrence within 24 months of BCG induction
If treated with a lenalidomide and dexamethasone combination, progression during the first 3 months after initiating treatment.
Have a history of gastrointestinal perforation and/or fistulae within 6 months prior to randomization.
Unstable angina within the last 6 months prior to registration
Expected survival > 12 weeks at the time of screening
On treatment with eculizumab (Soliris®) for at least 3 months
Active hepatitis B, unless patient has been on antiviral agents for at least 2 months (baseline testing not required)
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)
History of gross hemoptysis within 2 months of study entry.
Radiotherapy (except extremities) within 3 months prior to baseline imaging
Ipsilateral mammogram done greater than 6 months prior to study
Patients must be between 2-6 months post-transplantation at the time of study registration
Cerebral Vascular Accident (CVA) within 3 months prior to consent.
No radioimmunotherapy within 2 months prior to registration
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
Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis
Ability to comply with endometrial biopsies every 3 months
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)
Is not post-menopausal (defined as amenorrhea >12 consecutive months).
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
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
Has undergone a colectomy procedure in the previous two months
Radiotherapy to the target lesion within the past 3 months prior to baseline imaging
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
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
Patients may sign screening consent during recurrence or at time of remission if they can start vaccine therapy within 4 months of completing chemotherapy
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
No more than 3 years of ADT is allowed, with the most recent ADT treatment having occurred greater than 6 months prior to enrollment
Self-report of regular menstrual cycles >= 6 months (female only)
Current or planned pregnancy within the next three months (females only)
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
Unstable psychotropic medications (< 3 months)
Expected survival duration of > 3 months
Uncontrolled angina within 6 months before the Day 1 visit.
Subject underwent transplantation at least 3 months prior to enrollment
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.
Acute thrombosis within 3 months of screening
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.
Prior exposure to cardiotoxic agent, such as anthracyclines, within 3 months of enrollment
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
Postmenopausal defined as no menses for 12 or more months without an alternative medical cause OR
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
History of or plans for bilateral mastectomies within the next 12 months
Thromboembolism within 6 months of screening visit
Anticipated survival of at least 6 months
Patients with torsades de pointes within 12 months of study entry
Patients are eligible if an autologous transplant is planned within approximately 12 months from the time of collection of cells
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
History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
Molecular diagnosis of CP CML of ? 6 months (from initial diagnosis).
Expected survival > 6 months
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
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
Splenic irradiation within 3 months prior to Randomization
Unstable angina within 6 months prior to first dose
Progression of glioma must have occurred over 12 months or less.
Subjects must have expected survival of ?3 months.
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
History of hormonal therapy for endometrial carcinoma for more than 3 months;
History of use of progestins for a period of longer than 3 months for any indication, including endometriosis;
Thromboembolism within 6 months of cycle 1, day 1
History of arterial thrombotic or embolic events (within 6 months prior to study entry)
History of arterial or embolic events (within 6 months prior to study entry)
Not have received bacillus Calmette-Guérin (BCG) or have completed previous BCG treatment > 12 months prior to the baseline staging procedure.
Active malignancies within the past 12 months except negligible risk of metastasis or death treated with expected curative outcome.
Participants previously treated with bendamustine only if their duration of response was >/= 24 months
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
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
Refractory to ofatumumab (progression or relapse <12 months of receiving ofatumumab therapy or <24 months of receiving an ofatumumab- containing regimen)
Patients with life expectancy of =< 6 months for reasons other than their underlying hematologic/oncologic disorder
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
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
Subjects who are anticipated to receive a transplant within the first 6 months of treatment on trial
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.
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
Has a history of thromboembolic or cerebrovascular events within 6 months prior to registration
Alemtuzumab within 6 months prior to leukapheresis
Cladribine within 3 months prior to leukapheresis
Active malignancies within 12 months with the exception of those with a negligible risk of metastasis or death
Thromboembolism within 6 months of enrollment
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
Prior treatment with Gliadel wafer is allowed if it has been at least 3 months from placement
Patients treated with interferon or other anti-HCV therapy within 3 months prior to study entry
On beta-blocker treatment; if discontinued, patients must have been off beta-blockers for at least 3 months
Expected survival of at least 3 months
Expected survival > 3 months
Expected survival ? 6 months.
Expected survival > 2 months
Patients may have been treated with up to 4 months of androgen deprivation therapy
Prior androgen deprivation therapy (ADT) allowed if last dose was greater than (>) 6 months prior to randomization
Expected survival time of >= 3 months in the opinion of the investigator
Expected survival ?4 months.
Treatment initiation with BST no longer than 6 months prior to randomization
Expected survival > 12 weeks
Patients must be registered within 6 months of last dose of lenalidomide
Minimum of 3 months of maintenance therapy prior to disease progression
Patients who have taken any benzimidazole (ABZ, flubendazole, thiabendazole, fenbendazole, triclabendazole, etc.) within the last 3 months
Patient has been treated with nelfinavir within 3 months of entry into this trial
History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
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
No active alcohol addiction (as assessed by medical caregiver and defined as at least 6 months without activity)
Dose reductions due to neutropenia or thrombocytopenia in the past 6 months
Expected survival time of >= 3 months in the opinion of the investigator
History of venous or arterial thromboembolism within 12 months prior to enrollment/randomization
No CVA within 6 months, no MI within 6 months
History of treatment-resistant peptic ulcer disease, erosive esophagitis, gastritis, or diverticulitis within 3 months
No history of gross hemoptysis (defined as bright red blood of a half-teaspoon or more) within 3 months prior to enrollment
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
High-dose chemotherapy with stem-cell rescue: interval >= 3 months before study enrollment
Patients must be off hydroxyurea (HU) or erythropoietin (EPO) treatment for at least three months prior to entry onto the study
Recent exposure to cardiotoxic agents (including anthracyclines) within 3 months of enrollment. Subjects with troponin-I and BNP levels above ULN are excluded.
Prior myeloablative transplant within previous 3 months of study enrollment
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
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
Were postmenopausal for at least 24 months before the screening visit, OR
History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
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)
History of hemoptysis >= grade 2 (defined as bright red blood of at least 2.5 mL) =< 3 months prior to randomization
Anticipated patient survival under 3 months
History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
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.
Hospitalization for bowel obstruction within 3 months prior to enrollment.
Presence of any other medical complications that imply a survival of less than six months
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.
History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms
Expected survival time of at least 3 months in the opinion of the investigator
Patients who had radiosurgery > 3 months prior to registration are eligible
History of peptic ulcer within the last 6 months
AML relapsed > 2 months after transplant
History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
Use of bevacizumab or vascular endothelial growth factor inhibitor chemotherapy within 3 months before RT or 6 months after RT
Completed cancer specific therapy at most 6 months prior to entry
Reasonable expectation that no chemotherapy will be given in the subsequent 6 months (principal investigator's [PI’s] discretion)
Received anti-thymocyte globulin (ATG) within 6 months of screening
Biochemical or radiologic documentation of disease progression within the last 12 months prior to enrollment
Patients must have had FISH evaluation of leukemia cells within 3 months without intervening treatment demonstrating deletion 11q22-23
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)
Subject did not receive more than 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression
Open-label day 1 visit is within 6 months after this amendment is approved and becomes effective at the study site;
History of intracerebral abscess within 6 months prior to Day 1
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
Unstable angina pectoris ?6 months prior to study participation
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
Uncontrolled CHF (NYHA Class 2-4), angina, MI, CVA, coronary/peripheral artery bypass graft surgery, TIA, or PE in prior 3 months;
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
Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting study drugs
History of cerebral vascular accident (CVA) within 6 months
Estimated >4 months survival probability.
Expected survival duration of >= six months
Systemic infection that has not resolved > 2 months prior to initiating lenalidomide
History of thromboembolic disease within the past 6 months regardless of anti-coagulation
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)
Ability to comply with endometrial biopsies every 3 months
Negative bone scan within 6 months prior to enrollment to rule out possibility of metastases;
use of any 5ARI drugs within 3 months prior to enrollment such as Finasteride (Proscar) or Dutasteride (Avodart);
Patients taking chronic erythropoietin are permitted provided no dose adjustment is made within 2 months prior to start of first dose.
The patient has progressed within 6 months after completion of curative intent (definitive) treatment for localized/locoregionally advanced disease.
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
Exposure to household contacts =< 15 months old or household contact with known immunodeficiency
Expected survival >= 3 months from study entry
Cardio or cerebral vascular event within 6 months
Progression should have occurred within the immediate prior 2 months of the time of screening visit, with no intervening anti-cancer therapy
Male subjects must not donate sperm during the Screening and Treatment periods, and for at least 3 months after the last dose of ALXN1007.
Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis
Males must agree not to donate semen or sperm for 3 months after last dose of CC-122.
Anticipated patient survival under 2 months
Splenic irradiation 3 months prior to enrollment.
Anticipated survival of at least 6 months
Less than 12 months since diagnosis
Vasectomy or other procedure resulting in infertility (eg, bilateral orchiectomy) for >6 months
Predicted not to have significant clinical progression at 4 months
Previously enrolled and treated for at least 9 months in Study NEOD001-001
Patients with life expectancy of =< 6 months for reasons other than their underlying hematologic/oncologic disorder or complications there from
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
Prior treatment with docetaxel within 6 months of enrollment
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.
Vasectomy or other procedure resulting in infertility (e.g., bilateral orchiectomy), performed at least 6 months before screening
History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
Expected survival ? 6 months.
Subject with prior history of thrombotic microangiopathy or HUS within 3 months prior to enrollment
Refractory to obinutuzumab (defined as progression or relapse <12 months of receiving obinutuzumab monotherapy or <24 months of receiving an obinutuzumab-containing regimen)
History of gastrointestinal perforation and/or fistulae within 6 months prior to course 1 day 1 (C1D1)
Relapsed within three months post-transplant
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
Grade 3 or 4 eye disorder at study entry, unless stable and longstanding (>3 months) and unlikely to interfere with protocol-required ophthalmology assessments.
Anyone with a second malignancy expected to require cytotoxic chemotherapy or immune modulating therapy within 3 months of enrollment
Expected survival > 3 months
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
Radiotherapy within the last 2 months in the area to be treated
At least 6 months from prior splenic irradiation
Radiosensitizing doses of gemcitabine if relapse occurred at least 6 months after completion of gemcitabine;
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.
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
Progressed while receiving this gemcitabine regimen or within 3 months of completing gemcitabine
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.
Participation in a therapeutic research trial within the past three months
Expected survival of at least 4 months.
Significant circulatory disorders in the past 6 months
Patients enrolled must, in the Investigator's judgment, be healthy enough to stay on the clinical trial for three months.
History of certain cardiovascular conditions within the past 6 months.
History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
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
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.
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
History of Grade 3 or greater thromboembolic events in the prior 12 months
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.
Anticipated survival of at least 3 months
Prior myeloablative transplant within the last 6 months
Splenic irradiation within 3 months prior to the first dose of MMB
Have a history of GI perforation and/or fistulae within 6 months prior to receiving study drugs.
Participants with a history of gross hemoptysis within 2 months prior to study treatment
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)
History of hemorrhagic or ischemic stroke within 6 months prior to first dose of mirvetuximab soravtansine
History or evidence of thrombotic or hemorrhagic disorders within 6 months prior to first dose of mirvetuximab soravtansine
Greater than 3 months since melanoma resection;
Male patients must agree not to donate sperm during the study and for 3 months after discontinuation of vismodegib
Subjects previously treated with a systemic photosensitizer within 4 months of screening date
Hemorrhagic, embolic, or thrombotic stroke within 6 months of scheduled dosing day 1;
History of epistaxis requiring medical/surgical intervention (such as nasal packing) within the past 6 months
Poorly controlled ascites and/or requirement for therapeutic paracentesis more frequently than once every 3 months.
Symptomatic encephalopathy within 3 months prior to the first dose of TKM-080301 and/or requirement for medication for encephalopathy.
Anticipated patient survival under 3 months
Anticipated survival under 3 months
Less than three months since last taxane-containing therapy.
have not been treated with a taxane within six months of C1D1, AND
Important cardiovascular events in the past 6 months.
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.
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
No known Food and Drug Administration (FDA)-approved therapy available that’s expected to prolong survival by greater than 3 months
On a gluten-free diet for at least 6 months
Both must be measured within 3 months of enrollment;
Recent history of cellulitis in the affected extremity (within last 3 months)
Unstable lymphedema (i.e. worsening symptoms/measurements in the past 3 months)
Statin use in the last 6 months
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:
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
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
Participants must have histologically confirmed intrahepatic cholangiocarcinoma (IHC) without evidence of extrahepatic metastasis within 3 months prior to study registration
Expected survival must be three months or greater
Participants with a serious medical illness which may limit expected survival to less than 3 months
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)
Removal of stent is scheduled to occur within six months
History of severe haemorrhagic or thromboembolic event in the past 12 months
Confirmed progressive disease within 18 months of enrollment on study
Received regional hepatic infusion therapy within 6 months of enrollment (RFA allowed >6 months prior to enrollment)
Expected survival of at least 3 months.
Evidence of encephalopathy within last 3 months
History or signs of active coronary artery disease with or without angina pectoris within the last 6 months.
Is within 2 months of transplant from C1D1
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
Anyone with a second malignancy expected to require cytotoxic chemotherapy or immune modulating therapy within 3 months of enrollment
Coronary or peripheral artery bypass graft within 6 months of screening
Prior treatment with Gliadel wafer is allowed if it has been at least 3 months from placement
Time to treatment failure from doxorubicin containing regimen ? 12 months if previously treated with doxorubicin.
History of arterial or venous thrombotic/embolic events =< 12 months prior to registration
Patients with prior paclitaxel exposure are ineligible unless they are > 6 months from the conclusion of paclitaxel-based therapy
If receiving hydroxyurea or erythropoietin, treatment must have been prescribed for at least 6 months, with the dose stable for at least 3 months
Between 2 and 10 sickle cell-related pain crises in the past 12 months
The transplant occurred > 6 months ago
Recent (? 3 months) history of partial or complete bowel obstruction.
Exposure to high dose Ara-C within 6 months of enrollment.
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
Treatment with at least 2 months of abiraterone prior to progression
Expected survival longer than 3 months from enrollment in the study
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
Use of LHRH agonist or antagonist treatment within 6 months prior to randomization.
Subject had a painful crisis requiring hospitalization within the preceding 14 days or has experienced > 5 hospitalizations for VOC in the prior 6 months
Recent initiation (within 6-months) of anti-hypertensive medication (individuals on stable therapy may be enrolled)
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
Disease progression in the past 14 months
Uncontrolled angina within 3 months of Screening visit;
History of significant cerebrovascular disease in the past 3 months or ongoing event with active symptoms or sequelae
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
History of cerebral vascular accident (CVA) within 3 months prior to registration
Have expected survival of ?12 months.
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
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)
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
Patients may not have had more than 7 days of treatment with ketoconazole by mouth in the past 6 months
History of venous or arterial thromboembolism within 12 months prior to enrollment/randomization
Evaluation by a thoracic surgeon and a radiation oncologist within 2 months of registration
Any history of CVA or TIA in previous six months
Daily smoker for ?6 months
Bisphosphonate therapy currently or within the past 12 months
History of certain cardiovascular conditions within the past 6 months.
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)
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
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.
Diagnosed venous thromboembolic disease within the preceding 6 months (patient on full dose or prophylactic anticoagulation are eligible)
At least 3 months must have passed since last BCG therapy or intravesical treatment for bladder carcinoma.
History of CVA within six months
Progression during the first 3 months of initiating treatment
The patient has received Fludarabine, Clofarabine or Cloretazine within 12 months preceding the ASCI treat-ment.
Current or recent pregnancy (within 12 months),
History of prior treatment with chloroquine for malaria within past 24 months.
Thrombotic or thromboembolic events within the past 6 months:
History of arterial thromboembolic disease within 6 months of first study treatment
> 18 months (mos.) and =< 35 years at the time of initial diagnosis
No prior treatment (patients on \watch and wait\ may enter the study if a recent biopsy [obtained within the last 6 months] is available)
History of a thrombotic or thromboembolic event (arterial or venous) in the past 6 months
Fludarabine or Campath within 12 months prior to study entry
Availability of subject to be observed for up to 18 months post-screening evaluation
Patients with a history of the arterial or venous thromboembolism within =< 12 months of study entry are not eligible
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
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
Uncontrolled angina within 6 months prior to study entry;
Plan to treat with anastrozole for at least 12 months
Expected survival > 3 months
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
No bevacizumab =< 3 months of study registration
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)
Have practiced yoga >= 1 day a week within the 3 months prior to enrolling in the study
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
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
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)
Patient with a history of a thrombotic event within 12 months of starting nintedanib treatment
Not in a committed relationship for at least 6 months
Expected survival < 12 months
Life expectance of at least three months
Participants with evidence of active thromboembolic disease or a history of thromboembolism within the preceding 6 months (excluding thrombosis of a central line)
AIM 2: Must be a current or recent former smoker (defined as smoked within past 6 months)
AIM 2: Former smoker greater than 6 months
Enroll =< 3 months post-diagnosis (as soon as possible after diagnosis is desirable)
Patients must be >= 6 months from craniotomy
>= 6 months post active treatment
Already have an ongoing regular yoga practice within 2 months of study enrollment
History of arterial or venous thromboembolic disease 6 months prior to screening
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.
Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide administration.
Subject is a current smoker, or has smoked within 3 months prior to enrollment, or plans to resume smoking within 3 months post-enrollment
Has nursed a child within 3 months of study enrollment
Do not smoke (no smoking during previous 12 months)
No active cancer therapy (excluding chemoprevention) in the past three months, and no cancer therapy currently planned in the next 6 months
Patient’s attending medical oncologist would not be surprised if the patient died in the next 12 months
Having finished radiotherapy at least two months ago
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
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
Planning on remaining in New York City (NYC) for at least 7 months
Licensed taxi driver for at least three months
At least 2 months was passed since the hysterectomy at time of visit 2
HSCT procedure scheduled within two months of consent
Active yoga practice < 3 months
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
Current or past (< 6 months) engagement in PCST for cancer
Those who plan on relocating outside the greater Pittsburgh area in the next 3 months of intervention.
Use of intravenous antibiotics within the last 6 months
Have a documented visit with an oncologist during the previous 6-months
As per medical record, =< 9 months post-RP
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
Patient is anticipating leaving the area within the next 12 months
Non-steroidal joint injection within the last 3 months
PATIENTS ONLY: Have a romantic partner with whom they have resided for a minimum of 6 months
Patients must report neuropathic pain for a minimum of 3 months
History of incontinence defined as any pad use for urinary leakage in the past 6 months
Active or recent (within prior 3 months) thrombus, irrespective of anticoagulation status
Currently (previous 6 months) engaged in structured exercise either aerobic or yoga based
Probability of survival is at least 6 months
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
History of arterial or venous thromboembolic event within 12 months prior to study participation
Use of finasteride or dutasteride within 3 weeks or 6 months, respectively, of study entry
Antidepressant users who have been medicated for at least three months will not be excluded
Pain duration > 2 months
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
Treatment for serious psychological disorders (e.g., schizophrenia) in the last 6 months
Current or past (< 6 months) engagement in pain coping skills training protocol for cancer
Neutrophil count less than 500 within 6 months prior to study enrollment
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
Patients must have had a transrectal ultrasound (TRUS)/endoscopic ultrasound (TEUS) staging within two months prior to treatment start
SUBJECT: A child has plans to start a new treatment for attention/memory problems in the next 3 months.
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
Expected survival of at least 3 months
Multiple or bilateral renal masses when more than one mass is operated on at the same time or within 4-months of each other
Negative se rum pregnancy test and not planning to be pregnant in the next 3 months
Inability to conceive after 6 months of unprotected intercourse with male
Substance use disorder within the prior six months
Greater than 6-months post diagnosis
Participated in an investigational study for radiation dermatitis within 3 months of the screening visit
History of active opioid abuse within the past 12 months
Separate episode of VTE or arterial thrombosis within 3 months of enrollment
Major bleed (WHO grade 3 or 4) within 6 months of enrollment
Medical conditions precluding participation in the intervention or likely to lead to death within 6 months, as determined by the principal investigator (PI)
Attending physician assessment of prognosis with expected life expectancy of > 2 months
Patients must have had neuropathic symptoms for a minimum of 3 months.
Use of ginseng capsules for fatigue, within the last 12 months
History of substance dependence in the past six months
Current suicide risk or significant intentional self-harm in the last six months sufficient to preclude treatment on an outpatient basis
Adult patients with hematologic malignancy who underwent an allogeneic HCT at least 3 months prior to study enrollment
Chronic use of any herbal or dietary supplement containing apigenin within the 3 months prior to entry on the study
Patients participating in a structured exercise program in the past 6 months (mos)
6 months post-treatment completion
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
Current or past (< 6 months) engagement in PCST for cancer
Require psychotherapy within the last three months
Expect to relocate from Northeast Ohio within 2 months
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
Current suicidal ideation or suicide attempt within past 3 months
Treatment expected to last no longer than 12 months (patient)
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)
Completed treatment for stage 1-3 breast cancer at least two months but not more than 24 months prior to enrollment.
Eligible after 2 months of completing all their active cancer treatment with the exception of long-term hormonal treatments or trastuzumab.
Current/recent (prior 12 months) pregnancy
Prior use of acupuncture within 3 months prior to the study entry
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)
Six to 36 months post treatment
Willing to travel to MD Anderson’s main campus for 2 visits (baseline and 6 months post-baseline)
Lives with a romantic partner >= 6 months
Patients must not be scheduled to discontinue their TKI under medical supervision within the next 3 months
Treatment of a thromboembolic event =< 6 months prior to randomization
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
Men recently treated (within 3 months) with radical prostatectomy or radiation
Plan to stay in the study area for 3 months
ONCOLOGIST: Planning to leave their current practice setting for other employment in the next 3 months
ONCOLOGY NURSE: Planning to leave their current practice setting for other employment in the next 3 months
PATIENT: Be those whose attending medical oncologist would not be surprised if the patient died in the next 12 months
2 months post treatment
Expected duration of ADT at least 12 months from date of study consent
First dose of LHRH agonist or antagonist no more than 6 months prior to date of study content
Active malignancies within 12 months with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome.
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.
History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction within 6 months prior to Day 1 of Cycle 1
Expected survival of at least 4 months
Gastrointestinal perforation or fistulae within 6 months prior to randomization.
Prior use of probiotics within 3 months prior to enrollment
Prior use of acupuncture for CIPN within 6 months prior to study entry
Patient and caregiver: A history of a psychiatric illness unrelated to the HSCT within the past 18 months
Patients who have smoked within the last 6 months, since smoking may interfere with relaxation and breathing
Patients who currently practice yoga or have taken a yoga class regularly within the last 6 months
Hospitalized for psychiatric reasons within the past 3 months
Active yoga practice within the past 6 months
History of active opioid abuse within the past 12 months
History of active opioid abuse within the past 12 months
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
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
Subject is anticipated to have therapy with TKI continued for >= 3 months
Vaginal dryness or dyspareunia must be present for at least two months prior to study entry
No prior history of bisphosphonate or denosumab use in the past 12 months
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
At least 3 months into the maintenance phase, with at least 6 months left of\n             maintenance therapy
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
If survival is deemed less than 6 months for any medical condition
Have a stable partner for six months who is willing to participate
Patient with bilateral manipulation of axilla within the last 24 months
Active or recent pancreatitis (within last 6 months)
Treatment with any neuropathic agent including taxane, platinum, vinca alkaloid, or bortezomib chemotherapy in the past 6 months
Had sexual activity at least once in past 12 months (Randomized Trial Study only)
Has been in a stable sexual relationship of at least 6 months’ duration (Randomized Trial study only)
Women using systemic or vaginal estrogen, testosterone, or dehydroepiandrosterone (DHEA) in the 12 months preceding the Benchmark Survey Study will be excluded
Completed active cancer treatment other than maintenance therapy >= 3 months ago
Spouses and patients must be married or cohabiting and in intimate relationship for at least 6 months
Chronic opioid use for over 6 months
Anticipate moving from the region in the next 4 months
Patients engage in shift work or travel across more than three time zones within three months prior to study
The subject agrees to follow-up examinations out to 6 months post-treatment
Previous therapy with cetuximab within 6 months of consent
Treatment with high dose systemic corticosteroids or continuous use of other immunosuppressants within the past 6 months
Unwilling to refrain from donation of bodily fluid (blood, platelets, etc.) within 7 months of last vismodegib dose
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
Treatment with any neuropathic agent including taxane, platinum, vinca alkaloid, or bortezomib chemotherapy in the past 6 months
Initiated therapy with either abiraterone plus a glucocorticoid or enzalutamide within the 3 months prior to randomization
Not previously engaged in regular exercise training (> 1-2 days/week [d/wk] for > 30 minutes/day [min/d]) in the past 6 months
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
Less than 3 months from myeloablative conditioning for autologous transplantation
Use of venlafaxine or hypnosis in the past 6 months
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
Patients must not have had a screening mammogram within the last 11 months prior to date of randomization
Patients >= 65 years without underlying renal insufficiency get GFR tested within 6 months of the exam.
History of finasteride or dutasteride use in the last 6 months
Prior treatment with finasteride or dutasteride in the past 6 months
Patient must not have undergone breast ultrasound within 12 months prior to randomization
Plan to move outside of Miami-Dade county during the next six months
Patients who have no plans to move out of the region in the next 12 months
Have not had a clinician-provided digital rectal exam in the prior 3 months
Treatment or removal of HSIL less than 6 months prior to randomization
Prior history of documented DVT or PE in the past 3 months
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
Use of any chemopreventive agents (selective estrogen receptor modulators [SERM]) in the last 3 months
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
Chronic, current or recent (within the past three months) use of leukotriene antagonists
History of autoimmunity that has not been controlled with treatment in the last 12 months
RECIPIENT: Experimental anti?CMV chemotherapy in the last 6 months
Subjects taking long-term systemic steroids defined as greater than 3 months in the past 12 months
Individuals with a history of diabetes, hypertension, or have smoked cigarettes in the last 12 months.
No cancer therapy in the prior 3 months (excluding chemoprevention agents)
Pregnant, or had given birth, or nursed at any time during the last 12 months
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
Willing to participate in a weekly behavioral modification group phone call for first 3 months and every 2 weeks for the second 3 months
No actinic keratosis (AK)/Bowen’s disease in the treatment fields within the last 3 months
Not have gardened in the past 2 gardening seasons
Smoke >= 10 cigarettes per day for the last 6 months
Current enrollment or plans to enroll in another smoking cessation program in the next 9 months.
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
Willing to participate in a weekly behavioral modification group phone call for 3 months
Used smoking cessation medications within the past three months
Patients who are post-menopausal (defined as 12 consecutive months without a menstrual period)
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])
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
Planning on remaining in New York City (NYC) for at least 9 months (with no vacations or trips to exceed two months)
Licensed taxi driver for at least 3 months
Will not be in the New York city (NYC) area for the duration of the study period (6-9 months)
Current enrollment or plans to enroll in another smoking cessation program in the next 6 months
Have had antibiotic therapy, probiotic supplements, or professional cleaning within the previous 3 months
Underwent screening or surveillance colonoscopy with removal of at least one adenoma within the last 9 months
Not currently taking aspirin (any dose) within the last 6 months
No immediate plans (within the next 3 months) to leave the city for vacation or for trips back to their home country
Interested in taking 3 months of varenicline
Agree to participate in this randomized smoking cessation trial with follow up assessments up to 12 months
Active psychosis or poorly controlled depression in the past 6 months
Any suicide attempt or poorly controlled depression in the past 6 months
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
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
Participants must not have used any other investigation agent within the last six months
Patient has taken finasteride or dutasteride during the prior 6 months
Known plans to relocate or move from the Pittsburgh area within the coming 6 months;
Received cessation treatment (including cessation counseling, NRT, bupropion, or varenicline) in past 2 months;
Participation in more than 3 research studies in the past 6 months.
Participation in a smoking study in the past 3 months.
Current enrollment or plans to enroll in another smoking cessation program in the next 12 months
Serious or unstable disease within the past 3 months
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
Patient has had previous exposure to Folotyn within 6 months of study enrollment
Willing to be followed-up for 6 months
Planning to leave the college within next 6 months
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
Patients with active eczema during the last 12 months
Estimated probability of surviving less than 3 months
Patients must have started on anastrozole and plan to continue on anastrozole therapy for a minimum of 12 months
Participants must have a dental examination within 6 months of enrolling in the study
Less than 3 months from myeloablative conditioning for autologous transplantation (if applicable)
Will live in Nashville or surrounding area for the next 6 months
Patients with ulcerative colitis in clinical remission (UCDAI) =< 1 for at least 3 months, regardless of how long ago they were diagnosed for UC
Receiving maintenance therapy with mesalamine for at least 3 months
Participants who have had any immunomodulatory treatment in the past 3 months will be excluded
Not have gardened in the past 2 gardening seasons
Used other smoking cessation medications within the past three months
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
Have reasonable organ function as documented by complete blood count (CBC) and metabolic chemistry profile (within 3 months prior to study entry visit)
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
Prior administration of anthracyclines is acceptable if therapy was completed > 6 months prior to study enrollment
Use of tamoxifen, raloxifene, or chemotherapy within the previous 6 months
Administration of any blood product within 3 months of enrollment
Estimated probability of surviving less than 3 months
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
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
Have no plans to move in the next six months
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
Pregnancy in the last 6 months/planned within the next 2 years or currently lactating
Sedentary (have not participated in a regular exercise program in the past 12 months)
Nonsmokers (not smoking during previous 12 months)
Male patients must agree not to donate sperm during the study and for 2 months after discontinuation of vismodegib
Experimental immunotherapies: 3 months
Vaccine based therapy: 3 months
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
Must have completed radiotherapy at least 12 months prior to entry
Subject has coronary artery disease with an ischemic event within 6 months prior to enrollment.
Vaccine-based and/or viral therapy: 3 months
Treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis
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
No change in menstrual patterns for the past 6 months preceding the time of registration
Have received other investigational agents within the past 3 months (preceding the time of registration)
Use of selective estrogen receptor modulators (SERMS) in the past 6 months, including tamoxifen and raloxifene
Previous treatment with acupuncture in the last 12 months
Participants must be able and willing to undergo a bronchoscopy before and after treatment for 6 months
Subject is aged 6 months to 21 years inclusive.
LHW: Live in the relevant area and intend to stay there for the next 12 months
PARTICIPANTS: live in relevant area and intend to stay there for at least 12 months
5 or more CPD for at least 6 out of past 12 months
Current or recent (< 3 months) breastfeeding (females only)
Current or planned pregnancy within the next three months (females only)
Current smoker (> 5 cigarettes per day for the past 3 months)
Agree to participate in the study and be available for 6 weeks of treatment and 6 months of follow-up
Estimated survival of at least 6 months.
Planning on changing diet or exercise behavior in the next 6 months
History of CMV end-organ disease within 6 months before randomization
Chronic, current or recent (within the past three months) use of leukotriene antagonists
Chronic, current or recent (within the past three months) use of glucocorticoids (systemic, topical and/or nasal sprays)
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
Interested in taking 3 months of varenicline
New onset of chest pain or arrhythmia in the past 2 months
has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo.
Occurrence of a varicella or HZ episode by clinical history within the 12 months preceding the first dose of study vaccine/placebo.
has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Must have pathologically confirmed squamous metaplasia or squamous dysplasia documented by autofluorescence bronchoscopy within the preceding 60 months
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
heart attack, acute (2 days) cardiac event or stroke in preceding six months,
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
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.
Daratumumab or other anti CD38 antibody treatment within 3 months prior to study enrollment
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
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
Locoregional treatment of hepatocellular carcinoma within the prior 3 months or chemotherapy within the previous 3 months
No anti-estrogen therapy for desmoid tumor within the past 6 months
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)
Acute prostatitis within the last 6 months
More than 6 MET PET scans within the previous 12 months
History of taken antibiotics in the previous 3 months
Prostatectomy at M. D. Anderson within 3 months from the time of MRSI
Year 3 visit can not exceed 3 years and 6 months from the baseline visit
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
Presently planned for ongoing octreotide according to current standard of care for at least 12 months (i.e. throughout the study follow-up period)
Expected lifespan less than 12 months by investigator assessment
LOCALIZED RCC TREATED WITH PARTIAL NEPHRECTOMY:\r\nExpected survival of at least 3 months
ADVANCED RCC TREATED WITH RADICAL NEPHRECTOMY:\r\nExpected survival of at least 3 months
Radiotherapy to the abdomen or pelvis within 6 months of the screening visit
Stroke or TIA within 12 last months
the use of the copper-releasing intrauterine device (to have been in place for at least 2 months prior to screening)
At least 4 months after HCT, either autologous or allogeneic (of any source, with any preparatory regimen, for any indication), prior to study treatment.
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.
Androgen deprivation therapy (ADT) in the past 3 months
Documented normal LVEF for at least 6 months after the initiation of recommended HF therapy
Subject has received a Feraheme® (ferumoxytol) Injection within the past 6 months.
Known history of ablative or excisional therapy to the cervix within the preceding 12 months.
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.
Not interested in quitting smoking in the next 6 months
Antibiotic use within 2 months of study enrollment or during the study by self-report
Major changes in eating habits within the past 3 months
Must have no known medical problems and have had a full medical exam within 6 months of the study
No international travel planned during the next 4 months
Postmenopausal (no menstrual cycle in the past 12 months)
Planned quit date within the next two months
Willing to maintain contact with the investigators for 12 months
Expected survival > 6 months
Antibiotic use within 2 months of study enrollment by self-report
Symptomatic coronary artery disease currently or within the past 6 months,
PATIENTS: A prognosis of 12 months or less based on the treating oncologist’s assessment
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
Planning on remaining in NYC for at least 1 year, (with no vacations or trips to exceed two months)
Licensed taxi driver for at least three months
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)
Recruit for at least 9 months at the point of enrollment
Interested in trying to quit in the next 3 months
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
Exclude patients who have a FOBT or colonoscopy scheduled within the last six months
A referring physicians estimate of patient life expectancy must be between 1-12 months
Patients must have completed all therapy for curative intent at least six months prior to chart audit
Occurrence of heart attack, stroke, or angina in the past 3 months
Known plans to relocate or move from the Pittsburgh area within the coming 3 months
Active plans to leave the country in the next 3.5 months
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
Expected survival longer than 3 months from enrollment in the study.
Expected survival of at least 3 months from the date of enrollment in the study.
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.
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.
Disease progression within 12 months prior to study enrollment.
no recent (past 3 months) cardiovascular trauma: MI, stroke
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.
Subsequently at 1, 2, 3 and 12 months after the initiation of therapy, and/or;
Disease progression or recurrence less than or equal to 12 months of prior autologous SCT
Expected survival of more than 6 months.
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.
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.
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.
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
Expected survival of at least 12 weeks after dosing.