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 range

12 Months

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Global incidence of grade II-IV acute graft versus host disease (GVHD) requiring rimiducid treatment

Timeframe: 1 year after last rivogenlecleucel infusion

Dose-limiting toxicity (DLT) of BPX-501

Timeframe: 56 days after last rivogenlecleucel or rimiducid infusion (whichever is later)

Trial details

NCT IDNCT03807063

SponsorFred Hutchinson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-31

View on ClinicalTrials.gov More Acute Bilineal Leukemia trials