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Rivogenlecleucel vs PTCy in Haplo-HSCT for AML/MDS
NCT03699475Phase 3
Key facts
- Status
- Terminated
- Start
- Dec 2018
- Primary completion
- Jul 2019
- Countries
- 1
- Modality
- Cell Therapies
- Drugs
- rivogenlecleucel
- Conditions
- acute myeloid leukemia (AML)myelodysplastic syndrome (MDS)
01
Overview
Phase 3, randomised, open-label trial of rivogenlecleucel in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) (3 arms), sponsored by Bellicum Pharmaceuticals, Inc. Primary endpoint: Dose Limiting Toxicities at 100 days. Started Dec 2018; status: terminated.
02
Design
3 arms- Study design
- RandomizedOpen-label
Phase 2: BPX-501
Single arm safety run-in with BPX-501.
Phase 3 Arm A: BPX-501
Experimental arm with rivogenlecleucel.
Phase 3 Arm B: PTCy
Active comparator arm with post-transplant cyclophosphamide.
03
Who it enrols
Patients with intermediate to adverse AML in CR1/CR2+ or high-risk MDS lacking a matched donor.
04
Endpoints
Primary
Dose Limiting Toxicities
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