Any factor included as exclusion criteria in the participating center’s treatment policy statement
EXCLUSION CRITERIA FOR SECOND-LINE THERAPY: Patients receiving any other investigational agents
EXCLUSION CRITERIA FOR SECOND-LINE THERAPY: Women who are pregnant or breastfeeding
Olaparib\r\n* No additional exclusion criteria
EXCLUSION CRITERIA FOR ENROLLMENT
EXCLUSION CRITERIA FOR T CELL TREATMENT:
PHASE I EXCLUSION CRITERIA
Patients meeting any one of these exclusion criteria will be prohibited from participating in this study.
Pregnancy or breastfeeding, or intending to become pregnant during the study Exclusion Criteria based on Organ Function or Medical History Cardiovascular Patients who meet the following cardiovascular exclusion criterion will be excluded from study entry:
TREATMENT EXCLUSION CRITERIA
The following are considered criteria for exclusion from the exploratory genetic research:
Medication-related exclusion criteria
TREATMENT EXCLUSION: Active hemorrhagic cystitis
Preoperative Exclusion Criteria
Intraoperative Exclusion Criteria
EXCLUSION CRITERIA FOR STRATA A, B, D AND E
Subjects with CNS disease are eligible, with exceptions as noted in the exclusion criteria
TREATMENT EXCLUSION CRITERIA
TREATMENT EXCLUSION
Cohort specific exclusion criteria (cohorts and groups without applicable specific exclusion criteria are not listed separately and should follow the general exclusion criteria)
DONOR: The NMDP guidelines for exclusion criteria will be used.
SCREENING PHASE EXCLUSION CRITERIA
SCREENING EXCLUSION CRITERIA
Normal MRI exclusion criteria will apply; a standard MRI safety form will be used to identify potential conditions warranting exclusion
MEDICATION-RELATED EXCLUSION CRITERIA
ATEZOLIZUMAB-SPECIFIC EXCLUSION CRITERIA
BEVACIZUMAB-SPECIFIC EXCLUSION CRITERIA
RECIPIENT EXCLUSION CRITERIA
IMMUNOTHERAPY-RELATED EXCLUSION CRITERIA
MEDICATION-RELATED EXCLUSION CRITERIA:
ADDITION EXCLUSION CRITERIA FOR GROUP A (LOW TUMOR BURDEN) ONLY
STEP 1 SCREENING EXCLUSION CRITERIA
COHORT 1 EXCLUSION CRITERIA
COHORT 2 EXCLUSION CRITERIA
COHORTS 1 AND 2 EXCLUSION CRITERIA
EXCLUSION CRITERIA FOR ALL STUDY ARMS
PART 1 EXCLUSION CRITERIA: Subjects < 0.5 M^2
DRUG-SPECIFIC EXCLUSION CRITERIA
EXCLUSION CRITERIA (ENROLLMENT)
EXCLUSION CRITERIA (TRANSPLANT)
PANOBINOSTAT MAINTENANCE EXCLUSION
EXCLUSION CRITERIA FOR SCREENING:
EXCLUSION CRITERIA FOR LYMPHODEPLETION CHEMOTHERAPY, JCAR014 AND DURVALUMAB:
EXCLUSION CRITERIA FOR PATIENTS WITH CLL, MCL, OR ALL (COHORT A)
EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Platelet count < 75,000/mm^3
EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Treatment with other investigational agent(s) within 30 days of planned lymphodepletion
EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Serum creatinine > 2.5 mg/dL
EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): SGOT > 5 x upper limit of normal
EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Bilirubin > 3.0 mg/dL
EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Patients who are HIV seropositive
EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Women who are breastfeeding
EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Patients who have contraindication to cyclophosphamide chemotherapy
EXCLUSION CRITERIA FOR TNBC: ANC < 1000/mm^3
EXCLUSION CRITERIA FOR TNBC: Platelet count < 75,000/mm^3
EXCLUSION CRITERIA FOR TNBC: Treatment with other investigational agent(s) within 30 days of planned lymphodepletion
EXCLUSION CRITERIA FOR TNBC: SGOT > 5 x upper limit of normal
EXCLUSION CRITERIA FOR TNBC: Bilirubin > 3.0 mg/dL
EXCLUSION CRITERIA FOR TNBC: Patients who are HIV seropositive
EXCLUSION CRITERIA FOR TNBC: Breast-feeding women
EXCLUSION CRITERIA FOR TNBC: Patients who have contraindication to cyclophosphamide chemotherapy
Subjects where more than 10% of the total esophagus volume receives more than 50% of the prescribed RT dose Main exclusion criteria for cPoP
Subjects enrolled on the combination therapy phase must satisfy the above exclusion criteria and also the following:
DONOR EXCLUSION CRITERIA:
EXCLUSION CRITERIA - ARM A:
EXCLUSION CRITERIA - ARM B:
EXCLUSION CRITERIA FOR ENROLLMENT: The presence of active GVHD requiring treatment
EXCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Creatinine >= 2.5
EXCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: HIV-1/2 or HTLV-1/2 positivity
SCREENING EXCLUSION CRITERIA
SCREENING EXCLUSION CRITERIA:
INTRA-OPERATION EXCLUSION CRITERIA (RANDOMIZATION ARMS ONLY)
Any patient ?18 and ?89 who presents for a colonoscopy and who does not have criteria for exclusion
BEVACIZUMAB-SPECIFIC EXCLUSION CRITERIA:
TREATMENT EXCLUSION CRITERIA:
CHEMOTHERAPY/CELL INFUSION EXCLUSION CRITERIA:
EXCLUSION CRITERIA FOR CONSENT B
Other exclusion criteria:
EXCLUSION CRITERIA AT TIME OF INFUSION:
INTRAOPERATIVE EXCLUSION CRITERIA:
Tumor type specific exclusion criteria
TREATMENT EXCLUSION CRITERIA:
EXCLUSION CRITERIA FOR CD34+ TOPOFF WITHOUT CONDITIONING (COHORT 2):
EXCLUSION CRITERIA (ALL COHORTS)
EXCLUSION CRITERIA (SUBJECTS STRATIFIED INTO THE THORAX HIGH VOLUME TREATMENT SITE)
Laboratory criteria for exclusion within 14 days prior to randomization.
Platelet count < 125x10^9 / L Exclusion criteria for Group 2
Pregnant or lactation. Exclusion criteria for HSV-Tk infusion:
PATIENT EXCLUSION CRITERIA:
DONOR EXCLUSION CRITERIA:
EXCLUSION CRITERIA FOR TREATMENT: WBC less than or equal to 2000/uL
EXCLUSION CRITERIA FOR TREATMENT: Hct less than or equal to 24%
EXCLUSION CRITERIA FOR TREATMENT: ANC less than or equal to 1000
EXCLUSION CRITERIA FOR TREATMENT: Platelets less than or equal to 75,000
EXCLUSION CRITERIA FOR TREATMENT: Creatinine greater than or equal to 1.5 x ULN
EXCLUSION CRITERIA FOR TREATMENT: Bilirubin greater than or equal to 2.0 x ULN
PHASE 2 SPECIFIC EXCLUSION CRITERIA
PHASE 1 AND GENERAL EXCLUSION CRITERIA
Patients should not enter the study if any of the following exclusion criteria are fulfilled
SCREENING EXCLUSION CRITERIA:
EXCLUSION CRITERIA FOR AUTOLOGOUS TRANSPLANT
EXCLUSION CRITERIA FOR MAINTENANCE THERAPY
Other Exclusion Criteria
EXCLUSION CRITERIA:
Must not meet any exclusion criteria defined in main study except for exclusion criteria \Subject must not have primary refractory disease\ which is related to prior carfilzomib
EXCLUSION CRITERIA SEARCH PHASE
EXCLUSION CRITERIA FOR TRANSPLANT PHASE: Life expectancy severely limited by concomitant illness or uncontrolled infection
Step I Exclusion Criteria:
Step II Exclusion Criteria:
TREATMENT EXCLUSION CRITERIA:
MEDICATION-RELATED EXCLUSION CRITERIA
METASTATIC SAFETY COHORT EXCLUSION CRITERIA
NEOADJUVANT EXCLUSION CRITERIA
Patients requiring treatment with strong CYP2C8 inhibitors Additional exclusion criteria for PDR001/Everolimus
EXCLUSION FOR ENROLLMENT/SCREENING (ARMS 1 AND 2)
EXCLUSION FOR TREATMENT (ARMS 1 AND 2)
Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements. Exclusion from the genetic research may be for any of the exclusion criteria specified in the main study or any of the following:
Exclusion Criteria – Arms B and C
EXCLUSION CRITERIA PRIOR TO TRANSPLANT:
STAGE I EXCLUSION CRITERIA:
STAGE 2 EXCLUSION CRITERIA:
Exclusion of patients with creatinine > 2.0
Exclusion of patients with bilirubin > 2.0
There will be no exclusion criteria based on organ function
There will be no exclusion criteria based on organ function.
EXCLUSION CRITERIA - MAIN PROTOCOL
EXCLUSION CRITERIA FOR CONTINUING THERAPY ON THE EXTENSION PHASE:
Exclusion criteria will include all criteria listed for the main protocol
EXCLUSION CRITERIA PRIOR TO CELL COLLECTIONS FOR DENDRITIC CELL GENERATION:
EXCLUSION CRITERIA - RECIPIENT
IBRUTINIB-SPECIFIC EXCLUSION CRITERIA
CARDIAC EXCLUSION CRITERIA:
There is no exclusion for the presence of cytopenias
Other Exclusion Criteria
IMMUNOTHERAPY-RELATED EXCLUSION CRITERIA:
General Exclusion Criteria
EXCLUSION CRITERIA FOR SCREENING:
EXCLUSION CRITERIA FOR TREATMENT:
EXCLUSION CRITERIA - INITIAL ENROLLMENT
EXCLUSION CRITERIA FOR TRANSPLANT RECIPIENT
EXCLUSION CRITERIA RELATED TO ZIV-AFLIBERCEPT
No prior treatment with systemic chemotherapy (except as noted in exclusion criteria # 10).
Prior chemotherapy or radiation therapy for this disease (laser and cryotherapy are allowed and are not considered exclusion criteria)
They are ineligible by virtue of meeting any exclusion criteria listed above
Other Exclusion Criteria
COHORT 1 EXCLUSION CRITERIA FOR APHERESIS/TUMOR BIOPSY PORTION OF THE TRIAL (closed to enrollment as of 6/22/13):
COHORT 1 EXCLUSION CRITERIA FOR IMMUNOTHERAPY PORTION OF THE TRIAL (closed to enrollment as of 6/22/13):
COHORT 2 EXCLUSION CRITERIA:
EXCLUSION CRITERIA FOR PATIENTS
PATIENT EXCLUSION CRITERIA
EXCLUSION CRITERIA-PATIENTS
EXCLUSION CRITERIA-FCGs
EXCLUSION CRITERIA FOR PARENTS: Patient declines assent/consent (if >= 7 years)
EXCLUSION CRITERIA FOR PARENTS: Parent or child participated on prior PRISM intervention study
EXCLUSION CRITERIA FOR PATIENTS: Patient declines assent/consent (if >= 7 years)
EXCLUSION CRITERIA FOR PATIENTS: Patient participated on a prior PRISM intervention study
EXCLUSION - STUDY 1: Parkinson's disease
EXCLUSION - STUDY 1: Active foot ulcer
EXCLUSION - STUDY 2: The inclusion/exclusion criteria follows similar criteria for study #1 except only patients with confirmed peripheral neuropathy (VPT big toe greater than 25 volt) will be included; patients who have completed clinical study 1 would be eligible for study 2 if they develop CIPN as defined by VPT assessment
EXCLUSION CRITERIA FOR PATIENT PARTICIPANTS
PHASE 1: No provider exclusion criteria
PHASE 3A/3B: PATIENT EXCLUSION CRITERIA: Non-English speaker
EXCLUSION CRITERIA SPECIFIC TO SURVIVORS:
EXCLUSION CRITERIA FOR BOTH SURVIVORS AND CO-SURVIVORS:
EXERCISE EXCLUSION CRITERIA:
No allergic reactivity has been associated with olfactory training and thus there is no need for any exclusion criteria related to this
There are no other agent-specific exclusion criteria
EXCLUSION CRITERIA FOR FOCUS GROUPS (PHASE I)
PATIENT EXCLUSION CRITERIA:
PREPROCEDURAL EXCLUSION CRITERIA:
PATIENTS EXCLUSION CRITERIA:
Hepatic encephalopathy Exclusion Criteria Specific to Arm B (Gastric Cancer) (Patients who meet any of the following specific exclusion criteria will be excluded from enrollment in Arm B:)
Ongoing treatment for epilepsy Exclusion Criteria Specific to Arm C (Metastatic Pancreatic Cancer) (Patients who meet any of the following specific exclusion criteria will be excluded from enrollment in Arm C:)
PATIENT PARTICIPANT EXCLUSION CRITERIA (PHASE 1 & 2)
EXCLUSION CRITERIA FOR GROUP 2A AND 2B
No exclusion criteria relating to concomitant medications
EXCLUSION CRITERIA-PATIENTS
EXCLUSION CRITERIA-CAREGIVERS
GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Patients who have an uncontrolled infection are not eligible
GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Additional agent specific criteria will be included with specific treatment subprotocols
READER STUDY EXCLUSION
EXCLUSION CRITERIA FOR ENROLLMENT (PRE-TRANSPLANT): Pregnant or breastfeeding
EXCLUSION CRITERIA FOR ENROLLMENT (PRE-TRANSPLANT): Karnofsky performance status < 60%
Exclusion criteria for RPFNA
Exclusion criteria for study intervention
DRIVERS EXCLUSION CRITERIA
Exclusion Criteria for 13C-MBT studies:
Exclusion Criteria for 31P-MRS studies
Eligible for donation according to the transplantation center Exclusion Criteria Donor:
A history of miscarriage in the last 6 months, in and of itself, will not be considered an exclusion
Good performance status (as defined in Exclusion Criteria)
There will be no exclusion criteria relating to concomitant medications
EXCLUSION CRITERIA FOR CALYPSO TRANSPONDERS:
EXCLUSION CRITERIA (ALL PATIENTS)
EXCLUSION CRITERIA FOR OPEN-ACCESS: More than 6 MET PET scans within the previous 12 months
EXCLUSION CRITERIA FOR ORAL LESION AND NORMAL TISSUE
EXCLUSION CRITERIA FOR DRY MOUTH STUDY
EXCLUSION CRITERIA FOR GUM STUDY
No other appropriate agent-specific exclusion criteria
CANCER-SPECIFIC EXCLUSION CRITERIA
GENERAL MEDICAL EXCLUSION CRITERIA
STEP 1: EXCLUSION CRITERIA FOR TUMOR COLLECTION
Subject Exclusion Criteria for Optional Contrast MRIs –Cohort 1 Only:
Common exclusion criterion
EXCLUSION CRITERIA - FOR MALE COHORT
EXCLUSION CRITERIA - FOR NORMAL HEALTHY FEMALE COHORT: Chronic therapy with any drugs, except oral contraceptives
EXCLUSION CRITERIA - FOR NORMAL HEALTHY FEMALE COHORT: Hospitalization for any reason up to 8 weeks before enrollment
EXCLUSION CRITERIA - FOR NORMAL HEALTHY FEMALE COHORT: Pregnancy, labor or miscarriage within 12 weeks before admission predicted date
HEALTHY VOLUNTEER EXCLUSION CRITERIA:
SITE EXCLUSION CRITERIA:
PATIENT EXCLUSION CRITERIA:
PATIENT PARTICIPANTS EXCLUSION CRITERIA:
DRIVER EXCLUSION:
TRIAL EXCLUSION:
PATIENT EXCLUSION:
PROSPECTIVE STUDY POPULATION EXCLUSION
CHART AUDIT EXCLUSION CRITERIA:
There are no specific exclusion criteria for this study.
No exclusion criteria for this study
Other Exclusion Criteria
Subjects must be otherwise healthy except for the diagnosis of cancer, as per the exclusion criteria listed below.