Rivogenlecleucel Donor Lymphocyte Immunotherapy in Treating Patients With Recurrent Blood Cancers… (NCT03807063) | Clinical Trial Compass
WithdrawnPhase 1
Rivogenlecleucel Donor Lymphocyte Immunotherapy in Treating Patients With Recurrent Blood Cancers After Stem Cell Transplant
Stopped: Insufficient funding
United States0Started 2020-01-02
Plain-language summary
This phase I trial studies the side effects and best dose of rivogenlecleucel, and how well it works, in treating patients with blood cancer that has come back (recurrent) after stem cell transplant. Donor T-cell therapy (rivogenlecleucel) may help control transplant-related infections after stem cell transplant.
Who can participate
Age range12 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Original HCT donor: The most recent transplant was from a related or unrelated donor with an allele-level match to the recipient at HLA-A, HLA-B, HLA-C, HLA-DRB1, HLA-DQB1 (10/10) or with a single antigen or allele mismatch (9/10), or with one or two umbilical cord blood units that are individually antigen-level matched to the recipient in at least 4 of 6 HLA loci (HLA-A, -B, -DRB1).
* Graft source: The most recent transplant (and any previous allotransplant) was from mobilized peripheral blood stem cells and/or bone marrow and/or umbilical cord blood.
* Transplant number: The relapse occurred after a 1st, 2nd or 3rd allogeneic HCT.
* Diseases: The subject relapsed or progressed with the same or related disease which prompted the previous allogeneic HCT.
* Leukemia (acute myeloid leukemia \[AML\], acute lymphoblastic leukemia \[ALL\], chronic myelogenous leukemia \[CML\], chronic lymphocytic leukemia \[CLL\], chronic myelomonocytic leukemia \[CMML\], blastic plasmacytoid dendritic cell, biphenotypic, bilineage)
* Myelodysplasia
* Myeloproliferative neoplasm
* Myelodysplasia/myeloproliferative neoplasms (including "unclassified").
* For subjects with persistent or relapsed acute B-cell lymphoblastic leukemia, the subject must have previously received a chimeric antigen receptor (CAR) T cell product and blinatumomab at any point (not necessarily to treat the current relapse or after the current allogeneic transplant), unless the subject is inelig…
What they're measuring
1
Global incidence of grade II-IV acute graft versus host disease (GVHD) requiring rimiducid treatment
Timeframe: 1 year after last rivogenlecleucel infusion
2
Dose-limiting toxicity (DLT) of BPX-501
Timeframe: 56 days after last rivogenlecleucel or rimiducid infusion (whichever is later)