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NCT03699475 · ClinicalTrials.gov registry record · Phase 2
Study of Haplo-HSCT + Rivogenlecleucel vs Haplo-HSCT + Post Transplant Cyclophosphamide in Patients With AML or MDS
A Phase 2 study, sponsored by Bellicum Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT03699475: Clinical Trial Phase 2 study, sponsored by Bellicum Pharmaceuticals.
NCT03699475 is a Phase 2 study that was terminated before completion, run by Bellicum Pharmaceuticals. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03699475, a Phase 2 study, was terminated before completion, sponsored by Bellicum Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study 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.
Primary Outcome
If any of the following adverse events that occur within the DLT window they will be considered a DLT: * Grade III or IV acute GVHD attributable to rivogenlecleucel and non-responsive to \> 1 dose of rimiducid treatment (plus standard doses (at least 1 mg/kg) of methylprednisone or dose equivalent of other corticosteroids, and/or calcineurin inhibitor) within 14 days * Grade 3-4 neurologic events attributable to rivogenlecleucel * Death due to any cause other than underlying disease * Any CTCAE
Interventions
- DRUG Cyclophosphamide
- BIOLOGICAL rivogenlecleucel
- DRUG rimiducid
- PROCEDURE haplo-HSCT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2018-12-27 |
| Est. Completion | 2019-07-23 |
| Phase | Phase 2 |
Why NCT03699475 stopped before completion
NCT03699475 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT03699475 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03699475 about?
NCT03699475 is a clinical study titled "Study of Haplo-HSCT + Rivogenlecleucel vs Haplo-HSCT + Post Transplant Cyclophosphamide in Patients With AML or MDS". 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.
What is the current status of trial NCT03699475?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2018-12-27. Estimated completion is 2019-07-23.
What interventions are being tested in trial NCT03699475?
The interventions under investigation include: Cyclophosphamide (DRUG), rivogenlecleucel (BIOLOGICAL), rimiducid (DRUG), haplo-HSCT (PROCEDURE).
Who is sponsoring clinical trial NCT03699475?
This trial is sponsored by Bellicum Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03699475's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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