Clinical trial · Interventional
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
NCT03699475CI-TRIAL-00070079THRIVEterminatedPhase 2 / Phase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding, portfolio re-prioritization
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| haplo-HSCT | Procedure | — | UNRESOLVED |
| rimiducid | Drug | — | UNRESOLVED |
| rivogenlecleucel | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- single-arm Phase II: 3 x 10E6 BPX-501 cell/kg
- description
- Determining the safety of maximum allowable Dose for BPX-501 starting at 3 x 10E6 cells/kg Rimiducid will be administered to inactivate rivogenlecleucel in the event of GVHD not responsive to standard of care treatment
- interventionNames
- Biological: rivogenlecleucel
- Drug: rimiducid
- Procedure: haplo-HSCT
- type
- EXPERIMENTAL
- label
- phase 3 Arm A: Dose Determined in phase 2 group (never completed)
- description
- αβ T cell and CD19+ B cell-depleted, related haploidentical hematopoietic stem cell transplantation (haplo-HSCT) plus rivogenlecleucel
- interventionNames
- Biological: rivogenlecleucel
- Drug: rimiducid
- Procedure: haplo-HSCT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: Signed informed consent Meeting institutional criteria to undergo allogenic HSCT Age 18-70 y/o (12-70 y/o in US only) Patients with AML or MDS as defined below: AML Patients Patients with intermediate to adverse AML as defined by ELN (Dohner, 2017). * AML in first complete remission (CR1) with high-risk features defined as \> 1 cycle of induction therapy required to achieve remission OR preceding MDS or myeloproliferative disease * AML in CR1 with intermediate-risk features * AML in second or subsequent complete response * AML with myelodysplasia-related changes (AML-MRC) * Therapy related AML in first or subsequent complete remission * De novo AML in second or subsequent complete remission MDS Patients * High or very-high risk MDS by IPSS-R classification * Intermediate risk or higher MDS patients who failed a hypomethylating agent Lack of suitable conventional donor (i.e. HLA 10/10 related or unrelated donor) At least a 5/10 genotypic identical haplotype match The donor and recipient must be identical, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-C, HLA-DRB1, and HLA-DQB1 Patients with adequate organ function Eastern Cooperative Oncology Group (ECOG) performance status: 0-2 Exclusion Criteria: * HLA 10/10 allele matched (HLA-A,-B,-C,-DRBl, and DQB1) related donor or unrelated donor * Autologous hematopoietic stem cell transplant ≤ 3 months before enrollment * Prior allogeneic transplantation * Active CNS involvement by malignant cells (less than 2 months from the conditioning) * Current uncontrolled clinically active bacterial, viral or fungal infection * Positive HIV serology or viral RNA * Pregnancy (positive serum or urine βHCG test) or breast-feeding * Fertile men or women unwilling to use effective forms of birth control or abstinence for a year after transplantation * Radiographic, histologic, or known history of cirrhosis * Overlapping MDS and myeloproliferative neoplasms (MPN) disease * Patients with acute promyelocytic leukemia (APL) * Known hypersensitivity to dimethyl sulfoxide (DMSO)
References
Publications (0)
Data not yet available
No reference posted for this study.