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 to participate in group 1 of the pilot study of the AYA-Hears instrument \r\nNote: participants in group 1 will not receive protocol-directed therapy
ELIGIBILITY CRITERIA - PHASE II (ARM D): Patient must not have Burkitt’s 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
Has adequate hematopoietic, coagulation, renal and hepatic function. Subject must remain eligible for continued treatment with tazemetostat according to the eligibility and treatment criteria from the antecedent study.
ELIGIBILITY CRITERIA AT TIME OF TREATMENT: EBV positive tumor
ELIGIBILITY CRITERIA AT TIME OF TREATMENT: Patients should have been off other investigational therapy for 30 days prior to infusion
MANUFACTURING SJCAR19: 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 -2 or -1 prior to infusion of anti-CD19 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 -2 or -1 prior to infusion of anti-CD19 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 7 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 1 ELIGIBILITY CRITERIA
ADDITIONAL COHORT 2 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
History of transfusion is acceptable and transfusions may be given to meet eligibility requirements
REP ELIGIBILITY: Has not had a partial or complete response to nivolumab treatment
REP ELIGIBILITY: Serum creatinine of =< 1.5 x institutional ULN
PRE-SCREENING ELIGIBILITY
STUDY TREATMENT ELIGIBILITY
Any patient not meeting institutional standard guidelines for transplant eligibility
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
Most recent HR and HER2 receptor testing should be used to determine eligibility.
ELIGIBILITY CRITERIA FOR nEGFR TESTING
ELIGIBILITY CRITERIA FOR STUDY THERAPY
Must meet eligibility criteria for initiation of part A with the exception of being allowed to have prior nivolumab in part A of this protocol
Patients receiving cytotoxic agents will be evaluated by the PI or his designee for eligibility suitability
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nAbsolute neutrophil count >= 1,500/mcL
PHASE I STUDY ELIGIBILITY CRITERIA: \r\nWhite blood cell (WBC) >= 3,000/mcL
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nPlatelets >= 100,000/mcL
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nTotal bilirubin =< 1.5 X the normal institutional limits
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 >= 15% expression of 14g2a.zeta
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: ECOG performance score of 2 or less
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Absolute neutrophil count > 500 mcL
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Platelet > 20,000 mcL
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Serum AST < 5 x institutional upper limit of normal (IULN)
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Total bilirubin < 3 x IULN
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Serum creatinine < 2 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 be currently receiving immunosuppressive drugs such as corticosteroids (excluding topical treatment), tacrolimus or cyclosporine
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 a life-threatening allergy to baker’s yeast or other components of the vaccines; no history of allergic reactions to the antibiotics neomycin, streptomycin or polymyxin B
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Must not have had a coma or long or multiple seizures within 7 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:
COHORT A SPECIFIC ELIGIBILITY CRITERIA:
COHORT B SPECIFIC ELIGIBILITY CRITERIA:
Hemoglobin > 8.0 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): =< 5 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): Preservation of renal function, serum creatinine did NOT increase by more than 2 fold above the normal range
(ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS): Total bilirubin =< 2.0 mg/dL
(ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS): No clinical evidence of uncontrolled active infectious process
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 =< 2, fractionation is not required for eligibility determination
Eligibility criteria cannot be waived
TREATMENT ELIGIBILITY:
TREATMENT ELIGIBILITY:
Patients older than 21 will be considered for eligibility at the discretion of the principal investigator (PI)
Positive 68Ga-PSMA-R2 PET/CT scan for central eligibility assessment. Patients who receive 68Ga-PSMA-R2 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 >100 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:
PHASE 1 SPECIFIC ELIGIBILITY CRITERIA
PHASE 2 SPECIFIC ELIGIBILITY CRITERIA
GENERAL ELIGIBILITY CRITERIA
ELIGIBILITY CRITERIA TO INITIATE TREATMENT (FOR SECONDARY REGISTRATION - COHORT 1 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-GD2-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 4 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.
Patients with multifocal or multicentric disease are eligible as long as at least one area meets eligibility criteria
PROSPECTIVE SCREENING ELIGIBILITY CRITERIA:
ALT <3 × 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.
Patient meets the eligibility criteria outlined above
CONSOLIDATION ELIGIBILITY:
Patients are eligible >= 6 weeks after therapeutic 131I-MIBG provided that all other eligibility criteria are met
Any individual that does not meet the eligibility criteria for transplantation or donor eligibility will not be a part of this trial
Subject is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator. Intraoperative Eligibility Criteria:
Note: Transfusions/infusions to meet eligibility criteria are not allowed but if in the opinion of the Principal Investigator, it is beneficial, the patient may be rescreened after receiving one of these procedures.
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
PHASE I PORTION ELIGIBILITY CRITERIA
The patient must - at the time of re-induction - satisfy all the eligibility criteria
ELIGIBILITY TO PROCEED TO OVA:
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 protocol’s eligibility/enrollment criteria for any reason
There is a high likelihood that the patient, in the opinion of the principal investigator (PI) will meet the protocol’s eligibility/enrollment criteria to proceed to transplant after standard therapy is completed
ELIGIBILITY CRITERIA FOR HISTORICAL CONTROL POPULATION
Patients with multicentric or bilateral disease are eligible if the target lesions meet the other eligibility criteria; samples from all available tumors are requested for research purposes
PRIMARY ELIGIBILITY (PRE-OPERATIVE [OP])
SECONDARY ELIGIBILITY
General Eligibility Criteria (All Parts)
Specific Eligibility Criteria, Part A
Subjects must meet general eligibility criteria.
Specific Eligibility Criteria, Part B
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
Patients who had prior lung resection are eligible provided they fulfill the rest of the eligibility criteria
Patients at institutions that elect to confirm eligibility locally may be pre-registered at the same time as they are randomized
Central imaging real-time review (72 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:
NON-RANDOMIZED OBSERVATIONAL COMPONENT ELIGIBILITY:\r\nEnglish-speaking
Patients must meet eligibility criteria for induction of myelosuppressive chemotherapy as defined by clinical standards
Eligibility criteria same as stage I
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 1) ELIGIBILITY CRITERIA:
USER/USABILITY TESTING (PHASE 2) ELIGIBILITY CRITERIA:
RANDOMIZED CONTROL TRIAL (RCT) (PHASE 3) ELIGIBILITY CRITERIA:
PATIENTS ELIGIBILITY CRITERIA:
CAREGIVERS ELIGIBILITY CRITERIA:
PATIENT PARTICIPANT ELIGIBILITY CRITERIA (PHASE 1 & 2)
CLINICIAN PARTICIPANT ELIGIBILITY CRITERIA
STAKEHOLDER PARTICIPANT ELIGIBILITY CRITERIA
PATIENT ELIGIBILITY REQUIREMENTS:
ONCOLOGIST ELIGIBILITY REQUIREMENTS:
Patients may undergo electrolyte repletion therapy to meet 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 ELIGIBILITY (AS PER SELF-REPORT)
ELIGIBILITY FOR THE OPTIONAL SUB-STUDY
ELIGIBILITY FOR THE 2-YEAR EXTENSION
GENERAL ELIGIBILITY (ALL PATIENTS):
ELIGIBILITY FOR REDUCED INTENSITY CONDITIONING:
Completed all eligibility questions
ELIGIBILITY CRITERIA FOR HIGH RISK PATIENTS FOR THE CLINICAL TRIAL
Subjects with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met: transplant was > 100 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
For patients enrolled on the fluorouracil, leucovorin calcium, irinotecan hydrochloride, and oxaliplatin (FOLFIRINOX) trial (HRPO# 201201124), their eligibility would include eligibility from that trial as well as the inclusion criteria outlined above
Subjects must satisfy one of the following conditions pertaining to their eligibility to undergo orthotopic liver transplantation (OLT):\r\n* HCC that is within Milan Criteria, i.e., TACE is indicated as a “bridge” to OLT (Group I); or\r\n* HCC that is outside Milan Criteria, i.e., TACE is indicated as a means of “down-staging” into transplant eligibility (Group II)
Required patient clinical data is not available for evaluation of eligibility criteria
PRIMARY ELIGIBILITY (PRE-OPERATIVE [OP])
SECONDARY ELIGIBILITY
PART A ELIGIBILITY CRITERIA
PART B ELIGIBILITY CRITERIA
Will include all prospective trial participants in this study that come from Twitter in response of our SM recruitment interventions, provided they meet the specific trial's eligibility criteria