Patients must be considered to be suitable RIC alloHCT candidates at the time of enrollment based on medical history, physical examination, and available laboratory tests. Specific testing for organ function is not required for eligibility but, if available, these tests should be used to judge eligibility.
ELIGIBILITY CRITERIA FOR SCREENING AND MOLECULAR PROFILING (STEP )
REGISTRATION ELIGIBILITY CRITERIA
REGISTRATION ELIGIBILITY CRITERIA:
ELIGIBILITY CRITERIA FOR STEP
ELIGIBILITY CRITERIA FOR STEP
INDUCTION ELIGIBILITY CRITERIA-STEP
POST-INDUCTION THERAPY ELIGIBILITY CRITERIA (PRIOR TO INTENSIFICATION-STEP )
ELIGIBILITY FOR CHEMOTHERAPY COHORT:
ELIGIBILITY FOR NON-CHEMOTHERAPY COHORT:
Patients must have met eligibility criteria for the screening step
ELIGIBILITY CRITERIA FOR PREREGISTRATION (STEP ):
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP ): Patients randomized to Arm may opt to switch to the -drug regimen following disease progression; these patients must be re-registered to the study and meet the eligibility criteria below
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP ): Note: G-CSF and platelet transfusions cannot be used to increase counts to meet eligibility criteria
ELIGIBILITY CRITERIA (STEP )
ELIGIBILITY CRITERIA - PHASE II (ARM D): Patient must not have Burkitts lymphoma/leukemia based on the WHO criteria
ELIGIBILITY FOR SCREENING
CRITERIA FOR DONOR ELIGIBILITY:
ELIGIBILITY CRITERIA FOR ENROLLMENT
Prior eligibility for and on study treatment from an antecedent vemurafenib protocol
ELIGIBILITY CRITERIA AT TIME OF TREATMENT: EBV positive tumor
ELIGIBILITY CRITERIA AT TIME OF TREATMENT: Patients should have been off other investigational therapy for days prior to infusion
MANUFACTURING SJCAR: Meets eligibility criteria to undergo autologous apheresis, or have previously undergone autologous apheresis
Eligibility for Infusion of Investigational Product:\r\n* Subjects will undergo a second evaluation of eligibility on day - or - prior to infusion of anti-CD CAR-T cell product. This eligibility criterion will include the inclusion and exclusion criteria required for enrollment with the following exceptions and additions.\r\n** Inclusion criteria exceptions: Hematologic function parameters will not be included as a pre-infusion eligibility criterion (because lymphodepletive chemotherapy is expected to cause pancytopenia).
Eligibility for Infusion of Investigational Product:\r\n* Subjects will undergo a second evaluation of eligibility on day - or - prior to infusion of anti-CD CAR-T cell product. This eligibility criterion will include the inclusion and exclusion criteria required for enrollment with the following exceptions and additions.\r\n* Exclusion criteria additions:\r\n** Use of corticosteroids within days prior to infusion (with exception of agents used for prevention of emesis during lymphodepletive chemotherapy).\r\n** Neurologic symptoms suggestive of an active central nervous system condition.\r\n** Signs or laboratory markers of active infection or systemic inflammatory response.
Participants must meet appropriate molecular eligibility criteria
ADDITIONAL COHORT ELIGIBILITY CRITERIA
ADDITIONAL COHORT ELIGIBILITY CRITERIA
ELIGIBILITY TO PROCEED WITH PERIPHERAL BLOOD MONONUCLEAR CELL (PBMC) COLLECTION
ELIGIBILITY TO PROCEED WITH RICKHAM PLACEMENT\r\n* Once research participants meet eligibility to proceed with Rickham placement, they will be deemed accrued on to the study
ELIGIBILITY TO PROCEED WITH CAR T CELL INFUSION
ELIGIBILITY CRITERIA FOR ENROLLMENT ON THE RE-TREATMENT STUDY
ELIGIBILITY FOR LYMPHODEPLETION CHEMOTHERAPY AND T CELL INFUSION
STUDY TREATMENT ELIGIBILITY
PRE-ASCT ELIGIBILITY CRITERIA
ELIGIBILITY CRITERIA TO BEGIN CONSOLIDATION THERAPY
CROSS-OVER ELIGIBILITY CRITERIA
Transfusions intended to elevate any parameters below solely for the intent of meeting study eligibility are not permitted
REGISTRATION ELIGIBILITY CRITERIA
Most recent HR and HER receptor testing should be used to determine eligibility.
REGISTRATION ELIGIBILITY
ELIGIBILITY CRITERIA FOR nEGFR TESTING
ELIGIBILITY CRITERIA FOR STUDY THERAPY
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nAll patients must have evaluable disease; biomarker-only disease is not considered evaluable; eligibility of breast cancer with bone only disease is a principal investigator (PI) decision on an individual patient basis
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nAbsolute neutrophil count >= ,/mcL
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nPlatelets >= ,/mcL
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nPatients who were treated with both olaparib and cediranib, either in combination or sequentially
ELIGIBILITY CRITERIA- ENROLLMENT AND HARVEST
ELIGIBILITY CRITERIA- HARVEST
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Autologous transduced peripheral blood T-cells with >= % expression of ga.zeta
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: ECOG performance score of or less
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Absolute neutrophil count > mcL
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Platelet > , mcL
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Serum AST < x institutional upper limit of normal (IULN)
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Total bilirubin < x IULN
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Serum creatinine < x IULN
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Must not be currently receiving any investigational drugs
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Must not have a tumor potentially causing airway obstruction
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Must not have received a tumor vaccine within previous six weeks
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Must not have a known hypersensitivity to rat monoclonal antibodies
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Must not have had a coma or long or multiple seizures within days after a dose of DTP or Tdap unless a cause other than the vaccine was indicated
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Must not have evidence of previous or current infection with hepatitis B virus
DONOR ELIGIBILITY CRITERIA:
Hemoglobin > . g/dL; may transfuse to meet eligibility
ELIGIBILITY CRITERIA FOR T-CELL PRODUCT INFUSION: Normal serum sodium levels without need for supplementation
ELIGIBILITY CRITERIA FOR T-CELL PRODUCT INFUSION: ALT (SGPT): =< x ULN
ELIGIBILITY TO PROCEED WITH PERIPHERAL BLOOD MONONUCLEAR CELL (PBMC) COLLECTION
ELIGIBILITY TO PROCEED WITH RICKHAM PLACEMENT
ELIGIBILITY FOR ENROLLMENT AND TO PROCEED WITH CAR T CELL INFUSION
ELIGIBILITY TO PROCEED WITH PERIPHERAL BLOOD MONONUCLEAR CELL (PBMC) COLLECTION
ELIGIBILITY TO UNDERGO LYMPHODEPLETION:
(ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS): Research participant has completed prescribed lymphodepletion
(ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS): Not requiring pressor support, not having symptomatic cardiac arrhythmias
(ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS): Preservation of renal function, serum creatinine did NOT increase by more than fold above the normal range
(ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS): Total bilirubin =< . mg/dL
ELIGIBILITY TO PROCEED WITH PBMC COLLECTION
ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED T CELLS:\r\n* Please note that none of these criteria are applicable of the research participant's donor is undergoing leukapheresis
ELIGIBILITY CRITERIA TO UNDERGO OPTIONAL T CELL ABLATION:\r\n* Please note that none of these criteria are applicable of the research participant's donor is undergoing leukapheresis
All subjects meeting eligibility criteria irrespective of gender, minority or other underrepresented status will be eligible for enrollment into the study
The protocol chairman will determine the eligibility of patients related to hepatic abnormalities
If total bilirubin is =< , fractionation is not required for eligibility determination
Eligibility criteria cannot be waived
ELIGIBILITY CRITERIA FOR REGISTRATION: ECOG performance status =<
TREATMENT ELIGIBILITY:
TREATMENT ELIGIBILITY:
Positive Ga-PSMA-R PET/CT scan for central eligibility assessment. Patients who receive Ga-PSMA-R as part of separate clinical protocol are eligible (must meet all study eligibility criteria)
Subjects with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met: transplant was > days prior to study enrolment; no active infection(s); subjects meets the remainder of the eligibility criteria outlined in this protocol.
ADDITIONAL INDUCTION ELIGIBILITY CRITERIA:
GENERAL ELIGIBILITY CRITERIA
ELIGIBILITY CRITERIA TO INITIATE TREATMENT (FOR SECONDARY REGISTRATION - COHORT PARTICIPANTS ONLY):
ELIGIBILITY CRITERIA: TREATMENT PROTOCOL
ELIGIBILITY CRITERIA PRIOR TO FIRST VACCINATION
SECONDARY ELIGIBILITY CRITERIA FOR GENE-MODIFIED HSPC INFUSION
ELIGIBILITY CRITERIA FOR HSPC TRANSPLANTATION
ELIGIBILITY TO RECEIVE T CELL INFUSION:
ELIGIBILITY CRITERIA FOR SECOND CELL INFUSION:
Subjects must meet all the initial eligibility criteria except for the requirement regarding previous anti-GD-CAR therapy
Eligibility for pre-selected salvage chemotherapy, according to the Investigator's assessment.
Have had chemotherapy or investigational therapy, with the exception of hydroxyurea, within weeks of study entry; previous treatment at any time with either ruxolitinib or decitabine as single agents will not exclude eligibility; previous stem cell transplant will also not exclude eligibility as long as other inclusion/exclusion criteria have been met
Once all other eligibility criteria are confirmed, must have an apheresis product of non-mobilized cells received and accepted by the manufacturing site. Note: Apheresis product will not be shipped to or assessed for acceptance by the manufacturing site until documented confirmation of all other eligibility criteria is received.
PROSPECTIVE SCREENING ELIGIBILITY CRITERIA:
REGISTRATION (POST-SURGERY) ELIGIBILITY CRITERIA
ALT < ULN NOTE: Laboratory results obtained during screening should be used to determine eligibility criteria. In situations where laboratory results are outside the permitted range, the investigator may retest the subject and the subsequent within range screening result may be used to determine the subject's eligibility.
REGISTRATION ELIGIBILITY CRITERIA
Patient meets the eligibility criteria outlined above
CONSOLIDATION ELIGIBILITY:
Any individual that does not meet the eligibility criteria for transplantation or donor eligibility will not be a part of this trial
Persistence of clinically relevant therapy related toxicity from previous chemotherapy and/or radiotherapy; this does not include hemoglobin or other hematologic or laboratory criteria, as long as eligibility criteria are met as outlined above
Patients may have had enucleation of one eye, as long as the remaining eye meets the eligibility criteria
ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS:
Exceptions to eligibility will not be granted for this study
REGISTRATION ELIGIBILITY CRITERIA
PHASE I PORTION ELIGIBILITY CRITERIA
ELIGIBILITY TO PROCEED TO OVA:
FURTHER ELIGIBILITY DETAILS FOR PATIENTS WITH OPERABLE DISEASE (COHORT ):
REGISTRATION ELIGIBILITY
ELIGIBILITY PRIOR TO CELL COLLECTIONS FOR DENDRITIC CELL GENERATION:
RANDOMIZATION ELIGIBILITY CRITERIA
In the event of significant BM involvement, the above hematologic criteria will not be required for enrollment eligibility
The patient currently does not meet the protocols eligibility/enrollment criteria for any reason
Patient must meet eligibility criteria for allogeneic transplantation
ELIGIBILITY CRITERIA FOR HISTORICAL CONTROL POPULATION
PRIMARY ELIGIBILITY (PRE-OPERATIVE [OP])
General Eligibility Criteria (All Parts)
Subjects must meet general eligibility criteria. The specific eligibility criteria listed here will apply to subjects enrolling to different cohorts of Part B.
Specific Eligibility Criteria, Part C - Subjects must meet general eligibility criteria.
Specific Eligibility Criteria, Part D - Subjects must meet general eligibility criteria
Patients may not have clinically symptomatic hypothyroidism; testing is not required for eligibility
ELIGIBILITY PRIOR TO INITIATING CT-:
STEP ELIGIBILITY CRITERIA
STEP ELIGIBILITY CRITERIA
Patients who had prior lung resection are eligible provided they fulfill the rest of the eligibility criteria
REGISTRATION/RANDOMIZATION ELIGIBILITY CRITERIA
Centers that standardly use positron emission tomography (PET) or magnetic resonance spectroscopy (MRS) to determine a diagnosis of radionecrosis are permitted to use these modalities to assist in their patient selection; however the criteria described for conventional MR and/or DSC should also be met for study eligibility; both PET and MRS are not mandatory for study eligibility
Central imaging real-time review ( hour turn around) to confirm eligibility (for institutions that opt to utilize central imaging review to confirm eligibility)
Patient eligibility criteria for entry into the project include:
FCG eligibility criteria include:
PATIENT ELIGIBILITY CRITERIA
FCG has been invited to participate in the trial with a patient who meets eligibility criteria
ELIGIBILITY CRITERIA FOR BOTH SURVIVORS AND CO-SURVIVORS:
The patient is enrolled on a COG trial that uses criteria for unrelated donor HSCT, which conflict with our eligibility criteria
PATIENTS ELIGIBILITY CRITERIA
FOCUS GROUP (PHASE ) ELIGIBILITY CRITERIA:
USER/USABILITY TESTING (PHASE ) ELIGIBILITY CRITERIA:
PATIENTS ELIGIBILITY CRITERIA:
PATIENT PARTICIPANT ELIGIBILITY CRITERIA (PHASE & )
CLINICIAN PARTICIPANT ELIGIBILITY CRITERIA
STAKEHOLDER PARTICIPANT ELIGIBILITY CRITERIA
PATIENT ELIGIBILITY REQUIREMENTS:
Eligibility will not be restricted by race or sex
Participants must have already met one or more eligibility criteria and have a reasonable expectation of meeting any remaining eligibility criteria for the therapeutic clinical trial
PATIENT REGISTRATION ELIGIBILITY CRITERIA:
ELIGIBILITY FOR THE OPTIONAL SUB-STUDY
ELIGIBILITY FOR THE -YEAR EXTENSION
GENERAL ELIGIBILITY (ALL PATIENTS):
ELIGIBILITY FOR REDUCED INTENSITY CONDITIONING:
Completed all eligibility questions
Subjects with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met: transplant was > days prior to study enrolment, no active infection; subject meets the remainder of the eligibility criteria outlined in the study protocol.
ELIGIBILITY CRITERIA FOR NORMAL-WEIGHT WOMEN IN PILOT STUDY
A pregnancy test will be used to determine eligibility in appropriate patients
STEP : ELIGIBILITY CRITERIA PRIOR TO TREATMENT OR OBSERVATION
Required patient clinical data is not available for evaluation of eligibility criteria
PRIMARY ELIGIBILITY (PRE-OPERATIVE [OP])
PART A ELIGIBILITY CRITERIA
PART B ELIGIBILITY CRITERIA
REGISTRATION ELIGIBILITY CRITERIA