CD24Fc for the Prevention of Acute GVHD Following Myeloablative HSCT
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Graft Versus Host Disease
- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia
- Hematopoietic Stem Cell Transplantation
- Myelodysplastic Syndromes
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The study is designed as a randomized, placebo-controlled, double blind, multicenter, phase III trial comparing two acute graft-versus-host disease (aGVHD) prophylaxis regimens: CD24Fc/tacrolimus / methotrexate (CD24Fc/Tac/MTX) versus placebo/tacrolimus / methotrexate (placebo/Tac/MTX) in the settin...
The study is designed as a randomized, placebo-controlled, double blind, multicenter, phase III trial comparing two acute graft-versus-host disease (aGVHD) prophylaxis regimens: CD24Fc/tacrolimus / methotrexate (CD24Fc/Tac/MTX) versus placebo/tacrolimus / methotrexate (placebo/Tac/MTX) in the setting of myeloablative conditioning (MAC), matched unrelated donor (MUD) allogeneic hematopoietic stem cell transplantation in patients with acute leukemia (AML/ALL) or myelodysplastic syndrome (MDS). The study agent, CD24Fc, will be administered through IV infusion on days -1, 14, and 28 at the dose of 480mg, 240 mg and 240mg, respectively. The placebo will be 100 ml normal saline IV solution.
Tracking Information
- NCT #
- NCT04095858
- Collaborators
- Not Provided
- Investigators
- Study Director: Medical Director Merck Sharp & Dohme Corp.
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