INCLUSION CRITERIA FOR SCREENING (STEP 0 - PREREGISTRATION)
INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1)
REGISTRATION INCLUSION CRITERIA:
REGISTRATION INCLUSION CRITERIA
INCLUSION CRITERIA FOR SECOND-LINE THERAPY: Platelets >= 75,000/mm^3
INCLUSION CRITERIA FOR SECOND-LINE THERAPY: Hemoglobin >= 9.0 g/dL
INCLUSION CRITERIA FOR THIRD-LINE THERAPY: ECOG performance status 0 or 1
INCLUSION CRITERIA FOR THIRD-LINE THERAPY: Platelets >= 75,000/mm^3
INCLUSION CRITERIA FOR THIRD-LINE THERAPY: Hemoglobin >= 9.0 g/dL
Inclusion criteria associated with type and status of lymphoma
INCLUSION CRITERIA ASSOCIATED WITH HIV-1 STATUS
GENERAL INCLUSION CRITERIA (TIMELINE: 8 WEEKS PRIOR TO START OF TRIAL, UNLESS OTHERWISE SPECIFIED)
SOLID TUMOR INCLUSION CRITERIA:
INCLUSION CRITERIA FOR T CELL TREATMENT:
STEP 2 SCREENING INCLUSION CRITERIA FOR LMS PATIENTS:
TREATMENT INCLUSION CRITERIA
SPECIFIC INCLUSION CRITERIA FOR PRE-SURGICAL COHORT:
Patients with cancer of unknown primary or a rare tumor (i.e., fewer than 15 cases per 100,000 per year) with no approved therapies; (patients in this inclusion criteria must meet all other exclusion and inclusion criteria except inclusion criteria #1)
REGISTRATION/RANDOMIZATION INCLUSION CRITERIA:
Preoperative inclusion:
Intraoperative inclusion:
INCLUSION CRITERIA FOR STRATA A, B, D AND E
TREATMENT INCLUSION CRITERIA
TREATMENT INCLUSION
RETREATMENT WITH MODIFIED T-CELLS INCLUSION CRITERIA: ALT (SGPT): =< 5 x ULN
INCLUSION - TREATMENT: Bilirubin ? 3x
INCLUSION CRITERIA FOR NK CELL DONOR
INCLUSION CRITERIA FOR SELECTED NK CELL DONOR
INCLUSION CRITERIA TO ENROLL AND PREPARE CELLS FOR SHIPPING TO UNIVERSITY OF MINNESOTA (UMN) FOR PROCESSING
INCLUSION CRITERIA FOR ELIGIBILITY TO RECEIVE TREATMENT
PATIENT-SPECIFIC INCLUSION CRITERIA
INCLUSION CRITERIA FOR URINARY SCREENING
INCLUSION CRITERIA FOR TREATMENT
SCREENING INCLUSION CRITERIA
RECIPIENT INCLUSION CRITERIA
OTHER INCLUSION CRITERIA:
REGISTRATION- INCLUSION CRITERIA
INCLUSION CRITERIA FOR GENETICS RESEARCH STUDY (OPTIONAL)
STEP 1 SCREENING INCLUSION CRITERIA
STEP 2 SCREENING INCLUSION CRITERIA
Within 3 weeks of any corticosteroids except per inclusion criteria above
COHORT 2 INCLUSION CRITERIA
PART 1 INCLUSION CRITERIA
PART 2 GROUP 1 INCLUSION CRITERIA: These criteria must be met by all subjects, regardless of bone marrow involvement with tumor
PART 2 GROUP 2A INCLUSION CRITERIA: These criteria must be met by all subjects, regardless of bone marrow involvement with tumor
PART 2 GROUP 3 INCLUSION CRITERIA: These criteria must be met by all subjects, regardless of bone marrow involvement with tumor
DRUG-SPECIFIC INCLUSION CRITERIA
INCLUSION CRITERIA (ENROLLMENT)
INCLUSION CRITERIA (TRANSPLANT)
PANOBINOSTAT MAINTENANCE INCLUSION
INCLUSION CRITERIA FOR SCREENING:
INCLUSION CRITERIA FOR LYMPHODEPLETION CHEMOTHERAPY, JCAR014 AND DURVALUMAB:
INCLUSION CRITERIA FOR PATIENTS WITH CLL, MCL OR ALL (COHORT A)
INCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Karnofsky performance status of >= 70%
CAPMATINIB INCLUSION CRITERIA: Life expectancy >= 12 weeks
CAPMATINIB INCLUSION CRITERIA: Platelets >= 75,000/mcL
ENTRECTINIB INCLUSION CRITERIA: ECOG performance status 0-2
ENTRECTINIB INCLUSION CRITERIA: Platelets >= 75,000/mcL
Additional inclusion/exclusion criteria per protocol.
INCLUSION CRITERIA FOR PATIENTS TO BE TREATED ON STRATA B OR C
INCLUSION CRITERIA - PART A
INCLUSION/EXCLUSION CRITERIA - PART B
INCLUSION CRITERIA - ARM A:
INCLUSION CRITERIA - ARM B:
INCLUSION CRITERIA FOR ENROLLMENT: The patient has been off all immunosuppression for at least 2 weeks at the time of PTCy-MILs collection
INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: No active acute infections
INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: No requirement for systemic steroids
INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Platelets >= 100,00/uL (transfusions are permitted)
INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: AST (aspartate aminotransferase) =< 3 x ULN
INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: ALT (alanine aminotransferase) =< 3 x ULN
INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Bilirubin =< 1.5 x ULN
SCREENING INCLUSION CRITERIA
SCREENING INCLUSION CRITERIA:
INCLUSION CRITERIA PATIENTS WITH SOLID TUMOR CANCERS AND MELANOMA
INCLUSION CRITERIA FOR PATIENTS WITH MALIGNANT MENINGIOMA
INCLUSION CRITERIA ALL PATIENTS
TREATMENT INCLUSION CRITERIA:
CHEMOTHERAPY/CELL INFUSION INCLUSION CRITERIA:
INCLUSION CRITERIA FOR OBSERVATION (CONSENT A)
INCLUSION CRITERIA FOR TREATMENT WITH VELIPARIB AND RADIATION (CONSENT B)
Patients with bilateral hydronephrosis unless at least one side has been stented and renal function fulfils the required inclusion criteria
INCLUSION CRITERIA AT TIME OF INFUSION:
EXCLUSION CRITERIA FOR REGISTRATION: subjects receiving chemotherapy regimens not specified in the inclusion criteria
TREATMENT INCLUSION CRITERIA:
INCLUSION CRITERIA FOR CD34+ TOPOFF WITHOUT CONDITIONING (COHORT 2):
INCLUSION CRITERIA (ALL COHORTS)
INCLUSION CRITERIA (SUBJECTS STRATIFIED INTO THE THORAX HIGH VOLUME TREATMENT SITE)
Patients with tumor parameters that fall outside of the inclusion criteria above will not be eligible
INCLUSION CRITERIA FOR NB
INCLUSION CRITERIA FOR CCT: minimum life expectancy of eight weeks
LV mass on CMR > 200 grams (g) Inclusion Criteria for Group 1
PATIENT INCLUSION CRITERIA:
DONOR INCLUSION CRITERIA:
REGISTRATION – INCLUSION CRITERIA
One or more of the inclusion criteria are not met
INCLUSION CRITERIA AT TIME OF INITIAL ENROLLMENT:
OTHER INCLUSION CRITERIA:
SCREENING INCLUSION CRITERIA:
CHEMOTHERAPY/ADOPTIVE CELL TRANSFER INCLUSION CRITERIA:
INCLUSION CRITERIA FOR AUTOLOGOUS TRANSPLANT
INCLUSION CRITERIA FOR MAINTENANCE THERAPY
Patients with bilateral hydronephrosis unless at least one side has been stented and renal function fulfills the required inclusion criteria
Anastomosis or procedure (TME) was performed differently from what was defined in the inclusion criteria.
INCLUSION CRITERIA:
Known active Hepatitis B or C infections Inclusion Criteria for Part B: To qualify for enrollment, the following criteria must be met:
INCLUSION CRITERIA FOR COLLECTION AND STORAGE OF PERIPHERAL BLOOD MONONUCLEAR CELL (PBMC)/T CELLS
INCLUSION CRITERIA FOR MODIFIED T CELL INFUSION
Participants with prior therapy, other than therapy specified in inclusion criteria
Tumor specific inclusion criteria:
Predicted life expectancy ?12 weeks. Inclusion Criteria Specific for Part A:
Step I Inclusion Criteria:
Step II Inclusion Criteria:
TREATMENT INCLUSION CRITERIA:
Patients must have acceptable organ function as defined below. However, as noted above, drug-specific inclusion/exclusion criteria specified in the protocol appendix for each agent will take precedence for this and all inclusion criteria:
Patients must fulfill all of the general inclusion criteria
Patients must fulfill all the general inclusion criteria
Inclusion Criteria – Arms B and C
INCLUSION CRITERIA PRIOR TO TRANSPLANT:
REGISTRATION INCLUSION CRITERIA: ECOG performance status =< 1
REGISTRATION INCLUSION CRITERIA: Hemoglobin >= 10 g/dL
STAGE I INCLUSION CRITERIA:
STAGE 2 INCLUSION CRITERIA:
INCLUSION CRITERIA - MAIN PROTOCOL
UNRELATED DONOR INCLUSION CRITERIA
History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer Open-Label Treatment Period: The following inclusion criteria apply to patients receiving enzalutamide or placebo during double-blind treatment. Eligible patients must meet all inclusion criteria.
Patients with locally recurrent sarcoma after surgery alone are eligible for enrollment if other inclusion criteria are met.
Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria as listed in the protocol Cohort C Inclusion Criteria:
SLE INCLUSION:
SYSTEMIC SCLEROSIS (SSc) INCLUSION:
MS INCLUSION:
No prior treatment for diagnoses in inclusion criteria 1
Diagnosis of grade 1 endometrioid endometrial carcinoma without the presence of one of the 3 criteria mentioned in inclusion criteria 1
INCLUSION CRITERIA - ALL PARTICIPANTS
INCLUSION CRITERIA - RECIPIENT
History of lymphoid malignancy other than those allowed per inclusion criteria
Prior chemotherapy other than inclusion criteria
Mesothelin-positive refractory/recurrent MPM (Group 2 only) Inclusion Criteria Part B
INCLUSION CRITERIA FOR SBRT vs. RFA RANDOMIZATION
INCLUSION CRITERIA FOR NON-RANDOMIZED SBRT ARM
Criteria:
Criteria:
Criteria:
REGISTRATION #1 INCLUSION CRITERIA
Inclusion Clinical Laboratories Criteria
REGISTRATION INCLUSION CRITERIA
INCLUSION CRITERIA - HPC-A CELL DONOR: Family member (first degree relatives)
INCLUSION CRITERIA - HPC-A CELL DONOR: Not breast feeding
Tumor invasion of bone (also see inclusion criteria)
Tumors in locations other than those specified in inclusion criteria
General Inclusion Criteria
INCLUSION CRITERIA FOR SCREENING:
INCLUSION CRITERIA FOR TREATMENT:
INCLUSION CRITERIA - INITIAL ENROLLMENT
INCLUSION CRITERIA - MAINTENANCE THERAPY AFTER HSCT
In addition to the above, key inclusion and exclusion criteria are listed below.
INCLUSION CRITERIA FOR TRANSPLANT RECIPIENT
INCLUSION CRITERIA FOR HAPLOIDENTICAL DONOR
INCLUSION CRITERIA (ALL SUBJECTS)
Concurrent treatment for cancer, with specific exceptions noted in inclusion criteria
Inclusion Criteria for Part 1 and Part 2
Other Inclusion criteria for Part 1
Other Inclusion criteria for Part 2
Inclusion Criteria for Part 3
The inclusion criteria for Part 3 will be based on emerging data from Parts 1 and 2 and will be specified in an amendment.
Key Inclusion Criteria:\n\n          -  Individuals in the primary Phase 3 study (Study GS-US-312-0116) who are compliant\n\n          -  Tolerating primary study therapy\n\n        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Can take oral med Part 2 Inclusion Criteria:
Can take oral med Part 3 Inclusion Criteria:
Can take oral med Part 4 Inclusion Criteria:
The clinical status of the patient at inclusion is one of the following:
Inclusion Criteria:\n\n        Exclusion Criteria:
COHORT 1 INCLUSION CRITERIA FOR APHERESIS/TUMOR BIOPSY PORTION OF THE TRIAL (closed to enrollment as of 6/22/13):
COHORT 1 INCLUSION CRITERIA FOR IMMUNOTHERAPY PORTION OF THE TRIAL (closed to enrollment as of 6/22/13):
COHORT 2 INCLUSION CRITERIA:
REGISTRATION INCLUSION CRITERIA
INCLUSION CRITERIA FOR SCREENING:
INCLUSION CRITERIA FOR TREATMENT:
INCLUSION CRITERIA FOR PHYSICIANS
INCLUSION CRITERIA FOR PATIENTS
INCLUSION CRITERIA FOR CROSSOVER THERAPY
INCLUSION CRITERIA-PATIENTS
INCLUSION CRITERIA-FCGs
INCLUSION CRITERIA FOR PARENTS: Parents of children who have been diagnosed with new malignancy between 1-10 weeks prior
INCLUSION CRITERIA FOR PATIENTS: Child who have been diagnosed with a new malignancy between 1-10 weeks prior
INCLUSION - STUDY 2: The inclusion/exclusion criteria follows similar criteria for study #1 except only patients with confirmed peripheral neuropathy (vibration perception threshold [VPT] big toe greater than 25 volt) will be included; patients who have completed clinical study 1 would be eligible for study 2 if develop CIPN as defined by VPT assessment
INCLUSION CRITERIA FOR PATIENT PARTICIPANTS
EXERCISE INCLUSION CRITERIA:
CROSSOVER RE-REGISTRATION - INCLUSION CRITERIA
STRATEGISTS INCLUSION CRITERIA
PATIENT INCLUSION CRITERIA:
Antiviral therapy per local standard-of-care if active hepatitis B virus (HBV) Inclusion Criteria Specific to Arm A (Patients must also meet all of the following specific inclusion criteria to be eligible for enrollment in Arm A:)
Anti-viral therapy per local standard-of-care if active hepatitis B virus (HBV). Inclusion Criteria Specific to Arm F (Patients must also meet all of the following specific inclusion criteria to be eligible for enrollment in Arm F:)
Anti-viral therapy per local standard-of-care if active hepatitis B virus (HBV). Inclusion Criteria Specific to Gastric Cancer (Arm B) (Patients must also meet all of the following specific inclusion criteria to be eligible for enrollment in Arm B:)
Absence of HER2 expression documented as in situ hybridization (ISH) negative on previously collected and assessed tumor tissue upon initial diagnosis of disease Inclusion criteria specific to metastatic pancreatic cancer (Arm C) (Patients must also meet all of the following specific inclusion criteria to be eligible for enrollment in Arm C:)
No previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease Inclusion Criteria Specific to mEC (Arm E) (Patients must also meet all of the following specific inclusion criteria to be eligible for enrollment in Arm E:)
INCLUSION CRITERIA FOR GROUP 2A AND 2B
INCLUSION CRITERIA-PATIENTS
INCLUSION CRITERIA-CAREGIVERS
INCLUSION CRITERIA FOR PATIENTS: Admitted to 6E with suspected or actual new diagnosis of leukemia or lymphoma within the past 24 hours
INCLUSION CRITERIA FOR PATIENTS: Completed education to at least the 6th grade level
INCLUSION CRITERIA FOR PATIENTS: No significant auditory or visual deficits with corrective devices
INCLUSION CRITERIA FOR PATIENTS: Physiologically stable
INCLUSION CRITERIA FOR PATIENTS: Not at end of life
INCLUSION CRITERIA FOR PATIENTS: No alterations in mental status
INCLUSION CRITERIA FOR FAMILY MEMBERS: Willing to view DVD and read education booklet
INCLUSION CRITERIA FOR FAMILY MEMBERS: Selected by patient to participate
INCLUSION CRITERIA FOR FAMILY MEMBERS: No alterations in mental status
INCLUSION CRITERIA FOR FAMILY MEMBERS: Completed education to at least the 6th grade level
READER STUDY INCLUSION
REGISTRATION/RANDOMIZATION INCLUSION CRITERIA:
REGISTRATION INCLUSION CRITERIA
REGISTRATION INCLUSION CRITERIA
INCLUSION CRITERIA FOR ENROLLMENT (PRE-TRANSPLANT)
DONOR INCLUSION CRITERIA
REGISTRATION/RANDOMIZATION INCLUSION CRITERIA
Inclusion criteria for screening RPFNA
DRIVERS INCLUSION CRITERIA
Patient plans to receive concurrent chemotherapy, other than the regimens specified in the inclusion criteria
Additional Inclusion Criteria Specific for Arm A:
Additional Inclusion Criteria Specific for Arm B:
Additional Inclusion Criteria Specific for Arm C:
REGISTRATION INCLUSION CRITERIA
Inclusion Criteria:\n\n          -  referrals from the New York State Smokers' Quitline\n\n          -  at least 18 years of age
GENERAL INCLUSION CRITERIA
One of the following inclusion criteria must be true for patient to be eligible for enrollment:
INCLUSION CRITERIA (INITIAL 10 PATIENTS WITH METASTATIC PROSTATE CANCER)
INCLUSION CRITERIA: MEN WITH UNTREATED PROSTATE CANCER
INCLUSION CRITERIA: FOR MEN WITH PRESUMED PROSTATE CANCER RELAPSE
INCLUSION CRITERIA FOR OPEN-ACCESS: Female participants of childbearing age must not be lactating
INCLUSION CRITERIA FOR ORAL LESION AND NORMAL TISSUE
INCLUSION CRITERIA FOR DRY MOUTH STUDY
INCLUSION CRITERIA FOR GUM STUDY
Subject must give written informed consent. Part B, Inclusion criteria All inclusion criteria as for Part A, except for inclusion criterion 2 which is replaced by:
STEP 1: INCLUSION CRITERIA FOR TUMOR COLLECTION
Completed and documented history and physical addressing all inclusion/exclusion criteria
Common inclusion criterion
INCLUSION CRITERIA - FOR MALE COHORT
INCLUSION CRITERIA - FOR NORMAL HEALTHY FEMALE COHORT: If breastfeeding, must be willing to discard breastmilk for 24 hours following zolpidem
INCLUSION CRITERIA - FOR NORMAL HEALTHY FEMALE COHORT: Ability to swallow study medication
HEALTHY VOLUNTEER INCLUSION CRITERIA:
SITE INCLUSION CRITERIA:
PATIENT INCLUSION CRITERIA:
CLINICIAN PARTICIPANTS INCLUSION CRITERIA:
PATIENT PARTICIPANTS INCLUSION CRITERIA:
GARAGE INCLUSION:
DRIVER INCLUSION:
TRIAL INCLUSION:
PATIENT INCLUSION:
HEALTH CARE PROVIDER INCLUSION CRITERIA:
CHART AUDIT INCLUSION CRITERIA (BASELINE):
CHART AUDIT INCLUSION CRITERIA (POST-INTERVENTION)
Cohort 4 (severe): Bilirubin > 3 × ULN; any AST Exception to Inclusion Criterion #5 for Subjects with Normal Hepatic Function: All subjects enrolled with normal hepatic function (N=10) must meet all inclusion criteria as outlined with the exception of Inclusion Criterion #5, which should be substituted with the following criterion to be enrolled into the study: