Trials / Terminated
TerminatedNCT03699475
Study of Haplo-HSCT + Rivogenlecleucel vs Haplo-HSCT + Post Transplant Cyclophosphamide in Patients With AML or MDS
A Randomized Phase II/III Study of αβ T Cell-Depleted, Related, Haploidentical Hematopoietic Stem Cell Transplant (Haplo-HSCT) Plus Rivogenlecleucel vs. Haplo-HSCT Plus Post-Transplant Cyclophosphamide (PTCy) in Patients With AML or MDS
- Status
- Terminated
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Bellicum Pharmaceuticals · Industry
- Sex
- All
- Age
- 12 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This study compares the safety and effectiveness of giving rivogenlecleucel (BPX-501 T cells) to patients with AML or MDS post haploidentical hematopoietic stem cell transplant compared to post-transplant cyclophosphamide.
Detailed description
In the Phase 2 portion, participants will undergo αβ T cell and CD19+ B cell depleted haploidentical HSCT followed by an infusion of a fixed dose of rivogenlecleucel (BPX-501 T cells) per kg. These participants will be evaluated for prespecified dose limiting toxicities (DLTs) for a 100-day dose limiting toxicity window. Following completion of the Phase 2 portion, participants will be enrolled and randomized to one of two treatment arms in the Phase 3 portion. * Arm A:αβ T-cell and CD19+ B-cell-depleted haplo-HSCT plus treatment with rivogenlecleucel * Arm B: haplo-HSCT plus post transplant cyclophosphamide Pediatric patients ages 12-17 will also be included in US only.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | rivogenlecleucel | Biological: T cells transduced with caspase 9 safety switch |
| DRUG | rimiducid | administered to inactivate rivogenlecleucel in the event of GVHD |
| DRUG | Cyclophosphamide | GVHD prophylaxis |
| PROCEDURE | haplo-HSCT | treatment for disease |
Timeline
- Start date
- 2018-12-27
- Primary completion
- 2019-07-23
- Completion
- 2019-07-23
- First posted
- 2018-10-09
- Last updated
- 2023-09-29
- Results posted
- 2023-09-01
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03699475. Inclusion in this directory is not an endorsement.