[c09aa8]: / clusters / 9knumclustersv2 / clust_2306.txt

Download this file

147 lines (146 with data), 22.6 kB

  1
  2
  3
  4
  5
  6
  7
  8
  9
 10
 11
 12
 13
 14
 15
 16
 17
 18
 19
 20
 21
 22
 23
 24
 25
 26
 27
 28
 29
 30
 31
 32
 33
 34
 35
 36
 37
 38
 39
 40
 41
 42
 43
 44
 45
 46
 47
 48
 49
 50
 51
 52
 53
 54
 55
 56
 57
 58
 59
 60
 61
 62
 63
 64
 65
 66
 67
 68
 69
 70
 71
 72
 73
 74
 75
 76
 77
 78
 79
 80
 81
 82
 83
 84
 85
 86
 87
 88
 89
 90
 91
 92
 93
 94
 95
 96
 97
 98
 99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
122
123
124
125
126
127
128
129
130
131
132
133
134
135
136
137
138
139
140
141
142
143
144
145
146
Males must agree to take appropriate precautions to avoid fathering a child from screening through follow-up
Dependency on IV hydration > day per week within the screening period
SCREENING/PRE-SCREENING REGISTRATION:
Positive test for latent TB at Screening (Quantiferon test)
Hematological and biochemical indices within acceptable ranges at Screening.
Hospitalization for an acute medical issue within weeks prior to screening visit that would otherwise not be managed in an infusion center or outpatient clinic setting (i.e., a patient admitted to complete a transfusion would not be ineligible)
Patients who are candidates for enrollment for the phase I or surgical studies must sign a screening consent and provide pre-trial tumor material for Rb testing unless testing is not needed due to diagnosis or the availability of prior Rb IHC results; the screening consent is to be obtained according to institutional guidelines
Hospitalization for more than days for documented febrile neutropenia, pneumonia, sepsis, or systemic infection in the days before screening.
Subject must have a brain scan performed during Screening or within months prior to signing informed consent;
Inclusion Criteria:\n\n Subjects must meet the following criteria to be included:\n\n - Willing and able to read, understand and sign an informed consent form\n\n - Confirmed diagnosis by enrolling physician of WAIHA\n\n - Must use medically acceptable contraception\n\n Exclusion Criteria:\n\n Subjects meeting any of the following criteria are to be excluded:\n\n - Subject unable or unwilling to comply with the protocol\n\n - Active non-hematologic malignancy or history of non-hematologic malignancy in the \n years prior to screening (exclusive of non-melanoma skin cancer and cervical cancer in\n situ)\n\n - Positive for HIV or hepatitis C antibody\n\n - Positive for hepatitis B surface antigen\n\n - Any exposure to an investigational drug or device within the days prior to\n screening\n\n - IVIG treatment within days of screening\n\n - Plasmapheresis or immunoadsorption within days of screening\n\n - Subject has any current medical condition that, in the opinion of the Investigator,\n may compromise their safety or compliance, preclude successful conduct of the study,\n or interfere with interpretation of the results
Hemoglobin >= . g/dL at least weeks prior to screening unless attributable to disease
ELIGIBILITY FOR SCREENING: EBV positive tumor (can be pending)
Patient inability to complete baseline screening -day diet record
The subject is neurologically stable for at least weeks prior to Screening.
Received bupivacaine or any other local anesthetic within days of screening.
Wash urine cytology sampled from the pyelocalyceal system documenting the absence of HG urothelial cancer, diagnosed not more than months prior to the screening.
Experienced at least VOC within the preceding 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 months prior to Screening
Ongoing hospitalization prior to Screening
Immunomodulatory therapy: ? days prior to screening.
Positive screening EBV antibody titer on screening test
Syncopal episode within months of screening
Active infection at screening or history of severe infection within the previous months, if clinically relevant at screening as considered by the investigator
CRITERIA FOR SCREENING
No clinical evidence of HSIL on screening examination; if HSIL is suspected, a biopsy will be done to exclude HSIL; patients whose screening visit reveals HSIL on biopsy, may be re-screened one time, >= months after therapy
Patients will not be seen for screening appointments or enrolled on the protocol if they have been hospitalized within the days prior to the screening appointment or the date of protocol enrollment
PRE-SCREENING: Mesothelin positive
PRE-SCREENING: No prior treatment with anetumab ravtansine (or any other mesothelin-based therapy)
Palpable splenomegaly of to cm below left subcostal margin on physical exam AND active symptoms of MF at the screening visit as demonstrated by presence of symptom score ? or symptom scores ? using the Screening Symptom Form
Grade ? hypotension at screening
Screening blood counts of the following:
Had alemtuzumab therapy within -weeks prior to screening.
Patients will not be seen for screening appointments or enrolled on the protocol if they have been hospitalized within the days prior to the screening appointment or the date of protocol enrollment
Patients must have a positive screening Epstein-Barr virus (EBV) antibody titer on screening test as this is required to protect against EBV infection during the time of lymphodepletion
Syncopal episode within months of screening
Psychiatric hospitalization within year of screening date
Had eculizumab therapy within three months prior to screening
Syncopal episode within months of screening
Have clinically acceptable laboratory screening results within certain limits
Use of oral glucocorticoids within month of screening
Use of alpha reductase inhibitor within month of screening or total use, within the last two years prior to screening, of > months
SCREENING:
HCV genotype performed during screening indicates infection with genotype or
Pregnant women must not take part in this trial and will be considered as screening failures.
Unstable heart failure defined as emergency hospitalization for worsening, or decompensated heart failure, or syncopal episode within month of screening. Implantable cardiac defibrillator (ICD) or permanent pacemaker (PPM) at screening
Orthopnoea of sufficient severity to preclude supine scanning as determined at screening
Orthopnoea of sufficient severity to preclude supine scanning as determined at Screening
Normal electrocardiogram at screening
Liver function tests documented within the screening period and on day - of treatment period:
Signed written informed consent forms HLA SCREENING: Women of childbearing potential must use adequate contraception MAIN SCREENING:
Inadequate tissue acquisition to allow for neoantigen screening.
Subjects with a malignancy that contains a non-synonymous mutation, insertion, or deletion in the TP gene determined prior to screening; TP mutation status at screening is NOT required prior to AMG- dosing; however, subjects found to have TP mutation and/or deletion from screening bone marrow biopsy as assessed by central deoxyribonucleic acid (DNA) sequencing conducted at Dr. Jeffrey Sklars laboratory at Yale University Cancer Center, will be removed from study after C and continue on standard-of-care KRd alone
The subject has an active cancer being treated with chemotherapy at the time of screening
PSTAT SCREENING: Availability of archival tissue specimen suitable for pStat testing; either paraffin-embedded or fresh frozen sample is allowed for screening; testing of either primary or recurrent specimen is allowed for screening
Participants must be hepatitis C negative =< months prior to screening
Patients must have a positive screening Epstein Barr virus (EBV) antibody titre on screening test as this is required to protect against EBV infection during the time of lymphodepletion
Patients must have a positive screening Epstein-Barr virus (EBV) antibody titre on screening test
All patients who have received prior chemotherapy for histologically proven advanced non-small cell lung cancer, and whose tumors display the appropriate phenotype, i.e. high ISG (ISGH), are eligible; results of tumor screening will be sent in writing from Lovelace Respiratory Research Institute within days of submitting tumor specimens for screening; screening may occur prior to failure of frontline, second, or third line regimen\r\n* Note: A separate informed consent document will be available for patients to undergo screening for ISGH status
Is suspected to have certain other protocol-defined diseases based on imaging at screening period
Hospitalization within weeks prior to screening
Bone marrow biopsy at screening (unless it was performed within months prior to screening)
Inadequate tissue acquisition to allow for neoantigen screening
Hb < g/dL at screening OR have received at least one transfusion within months prior to screening
SCREENING
SCREENING
Have circulating HAMA noted on initial screening
Patient has positive urine cytology for malignancy at Screening.
ELIGIBILITY FOR ENROLLMENT/SCREENING (ARMS AND ): Histopathological documentation of NSCLC or mesothelioma
Acute thrombosis within months of screening
Screening mTc-MDP bone scintigraphy showing a superscan;
Participants with hemoglobin level < . g/dL, at time of screening; transfusion may not be used to meet eligibility criteria within days of obtaining screening evaluation
Blood transfusion or erythropoietin stimulating agents prior weeks of screening and during the whole screening period before randomization
Participants with hemoglobin level < . g/dL, at time of screening; transfusion may not be used to meet eligibility criteria within days of obtaining screening evaluation
Diagnosed with cGVHD per the cGVHD NIH Consensus Criteria(Jagasia, ; Appendix ) within the past years prior to screening.
Moderate to severe cGVHD (in accordance with cGVHD NIH Consensus Criteria [Jagasia, ; Appendix ]) at screening with involvement of at least one of the following organs at the screening and baseline visits: skin, mouth, eyes, gastrointestinal (GI) tract, liver, lungs, and joint and fascia.
Patients who have not been tested within months prior to starting adjuvant therapy must be tested for hepatitis B and hepatitis C serologies during study screening\r\n* Patients with positive hepatitis B or C serologies without known active disease must meet the eligibility requirements for ALT, AST, total bilirubin, international normalized ratio (INR), activated partial thromboplastin time (aPTT), and alkaline phosphatase on at least two consecutive occasions, separated by at least week, within the day screening period
Received anti-thymocyte globulin (ATG) within months of screening
Ferritin> mcg/L at screening
Evidence of TLS at screening
Presence of DVT on pre-operative screening ultrasound study
Subjects who test positive for Clostridium difficile (C. difficile) at Screening.
The donor has donated plasma within days before screening or has donated blood within days before screening.
Recent chemotherapy within weeks of screening
Patients with proven TTP as per historical data (as defined by ADAMST activity test) and if already available results of ADAMST test done at screening.
Subject has hypokalemia or hypomagnesemia at screening.
Prior TACE < months prior to screening phase in case of patients progressing from an intermediate to an advanced stage due to occurrence of PVT
Known history of hepatitis C and recovery status has not been determined at time of screening
Inclusion Criteria:\n\n - Received an autologous or allogeneic HCT using any conditioning regimen\n\n - Documented to be RSV-positive as determined by local testing (eg, polymerase chain\n reaction, direct fluorescence antibody, respiratory viral panel assay, or culture)\n using an upper respiratory tract sample collected ? days prior to Day \n\n - New onset of at least of the following respiratory symptoms for ? days prior to\n Day : nasal congestion, runny nose, cough, or sore throat, or worsening of one of\n these chronic (associated with a previously existing diagnosis, eg, chronic\n rhinorrhea, seasonal allergies, chronic lung disease) respiratory symptoms ? days\n prior to Day \n\n - No evidence of new abnormalities consistent with LRTI on a chest X-ray relative to the\n most recent chest X-ray, as determined by the local radiologist. If a chest X-ray is\n not available or was not obtained during standard care < hours prior to screening,\n a chest X-ray must be obtained for screening\n\n - O saturation ? % on room air\n\n - An informed consent document signed and dated by the participant or a legal guardian\n of the participant and the investigator or his/her designee\n\n - A negative urine or serum pregnancy test is required for female participants (unless\n surgically sterile or greater than two years post-menopausal)\n\n - Male and female participants of childbearing potential must agree to contraceptive\n requirements as described in the study protocol\n\n - Willingness to complete necessary study procedures and have available a working\n telephone or email\n\n Exclusion Criteria:\n\n Related to concomitant or previous medication use:\n\n - Use of non-marketed (according to region) investigational agents within days, OR\n use of any monoclonal anti-RSV antibodies within months or half-lives of\n screening, whichever is longer, OR use of any investigational RSV vaccines after HCT\n\n Related to medical history:\n\n - Pregnant, breastfeeding, or lactating females\n\n - Unable to tolerate nasal sampling required for this study, as determined by the\n investigator\n\n - Known history of HIV/AIDS with a CD count < cells/?L within the last month\n\n - History of drug and/or alcohol abuse that, in the opinion of the investigator, may\n prevent adherence to study activities\n\n Related to medical condition at screening:\n\n - Documented to be positive for other respiratory viruses (limited to influenza,\n parainfluenza, human rhinovirus, adenovirus, or human metapneumovirus, or coronavirus)\n within days prior to the screening visit, as determined by local testing (additional\n testing is not required)\n\n - Clinically significant bacteremia or fungemia within days prior to screening that\n has not been adequately treated, as determined by the investigator\n\n - Clinically significant bacterial, fungal, or viral pneumonia within weeks prior to\n screening that has not been adequately treated, as determined by the investigator\n\n - Excessive nausea/vomiting at screening, as determined by the investigator, or an\n inability to swallow pills that precludes oral administration of the investigational\n medical product (for participants without an nasogastric tube in place)\n\n - Any condition which, in the opinion of the investigator, would prevent full\n participation in this trial or would interfere with the evaluation of the trial\n endpoints\n\n Related to laboratory results:\n\n - Creatinine clearance < mL/min (calculated using the Cockcroft-Gault method)\n\n - Clinically significant aspertate aminotransferase/alanine aminotransferase, as\n determined by the investigator\n\n - Clinically significant total bilirubin, as determined by the investigator
Hematological and biochemical indices within acceptable ranges shown at screening.
Screening endoscopic ultrasound if done prior to consent but within weeks of expected randomization date it may be used
A positive pre-study drug/alcohol screening (testing at time of screening is not required).
Certain scores on an anxiety and depression mood questionnaire given at screening
Major trauma within hours of screening
Subject has screening MOD score of ?
< % solid component on screening cross-sectional imaging
Patient has an Impact of Events Scale (IES) score >= and/or partner has an IES score of >= at the time of initial screening for eligibility
Has low confidence in requesting workplace accommodations (based on a brief screening survey). Low confidence is defined by having a score of or lower on any of the five measures
Documented, confirmed OIC defined as less than laxations per week over a -week OIC confirmation period at any time during screening and prior to initial treatment period day
Does not have health insurance at screening
Endorses fatigue as determined by eligibility screening and a score of < on Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F)
Patient treated with antifibrinolytic agents (including EACA) within days prior to screening
Intelligence quotient (IQ) below based on baseline/screening assessment
No documented bacteremia at time of initial screening
Patient should describe fatigue as being present for a minimum of weeks prior to screening
Patient already on NIPPV at the time of screening
Score of or greater (>= ) on the Prolonged Grief (PG)- at screening
Completion of successful fMRI safety screening
Is currently in a partnered relationship that could involve sexual activity (as determined by eligibility screening script)
ECOG performance status of or at screening and within hours prior to first dose if first dose occurs more than hours post-screening
Patient has a Karnofsky performance status (KPS) ? at Screening, and within hours prior to date of first dose if first dose occurs more than hours after screening (Part B only)
Serum albumin < g/dL at screening visit and within hours prior to first dose if first dose occurs more than hours post screening
Cancer patients currently on cancer therapy with a positive screening for SD (screening PSQI score >= )
Subject answers item # of muscle spasms questionnaire as moderate or severe intensity at time of screening
At least one muscle spasm per day at time of screening
Patients must not have had a screening mammogram within the last months prior to date of randomization
For those women who cannot be assigned to annual or biennial screening at the time of study entry and randomization because they are postmenopausal, have no family history or known deleterious breast cancer mutation, are not on hormone therapy AND for whom a prior mammogram interpretation is not available, breast density will be determined by the radiologists recording of it at the time of interpretation of the first study screening examination, either DM or TM; for those who are randomized to TM, radiologists will assign BI-RADS density through review of the DM or synthetic D portion of the TM examination; such women cannot be part of the planned stratification by screening frequency and are expected to represent far less than % of the Tomosynthesis Mammographic Imaging Screening Trial (TMIST) population
Receives screening breast MRIs at an outside facility other than the consenting institution
Patients who are undergoing colonoscopy for screening or surveillance purposes
Women who report no history of Pap screening within the last four years
Asymptomatic women presenting to the imaging center for a screening mammogram
Women scheduled for screening WBUS and a screening full field digital mammography (FFDM) on the same day or within the following days of each other
Men over the age of will be asked to participate in the educational component of the program; men over the age of will be offered the screening component after the educational portion of the event; participants over age of will have the opportunity to make an informed decision in regards to prostate cancer screening based on this information and the educational material; American Cancer Society (ACS) guidelines recommend having a discussion about screening in men who have a expected mortality of greater than years; data on comorbidities and -year mortalities will be collected on every participant using the University of California at San Francisco (UCSF) mortality index
Willingness to undergo radiographic evaluation if screening findings are abnormal
Patient must be asymptomatic for breast disease and undergoing routine screening
Patient must agree to not undergo screening ultrasound (of breast) for the duration of the year study period
Any women scheduled for screening WBUS and a screening FFDM on the same day or within the following days of each other
Women who have a screening digital mammogram on the day of CESM or within days prior
Participants who only have a single HSIL lesion that is likely to be removed entirely with the initial screening biopsy
For male patients, agreement to use condoms with spermicide during sexual intercourse from screening to the end of study; and
Women with mosaic mammographic screening views, i.e., whose larger breast size precludes being imaged within a single mammographic screening view
Screening HCV genotype, demonstrating genotype
Previous participation in this trial. Participation is defined as screening. Re-screening is not allowed.
Willingness to undergo screening tests and procedures
Psychiatric hospitalization within year of screening date
Underwent screening or surveillance colonoscopy with removal of at least one adenoma within the last months
Normal Pap or Atypical Squamous Cells of Undetermined Significance (ASCUS) Pap test with HPV deoxyribonucleic acid (DNA) negative by reflex testing via Hybrid Capture (Digene Corp., Gaithersburg, MD), a standard clinical assay within clinically acceptable screening guidelines (American Cancer Society [ACS]/American Society for Colposcopy and Cervical Pathology [ASCCP] Screening Guidelines)
Psychiatric hospitalization within year of screening date
Inflammatory eye disease requiring steroid treatment within days of screening
Willingness to undergo screening tests and procedures
Patient has received chemotherapy for any type of cancer within days from date of screening CDU;
The subject is clinically node negative (cN) at the time of screening
Subject with hypokalemia and hypomagnesemia at screening (defined as values below LLN).
FOBT or FIT screening completed within the last year
Half of the participants will be overdue for CRC screening and the remaining half will be current on their screening, as defined by national published guidelines
Due for CRC screening:\r\n* No colonoscopy within the prior years\r\n* No flexible sigmoidoscopy within the prior years\r\n* No fecal blood testing (FOBT or FIT) within the prior months
Positive Coombs tests at screening.