Vorinostat for Graft vs Host Disease Prevention in Children, Adolescents and Young Adults Undergoing Allogeneic Blood and Marrow Transplantation
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Myelogenous Leukemia - Chronic Phase
- Acute Leukemia in Remission
- Chronic Myelogenous Leukemia, Accelerated Phase
- Chronic Myelogenous Leukemia, Blastic Phase
- Diffuse Large B Cell Lymphoma
- Follicular Lymphoma
- Graft Vs Host Disease
- Graft -Versus-host-disease
- Non Hodgkin Lymphoma
- "Hematologic Diseases"
- Mantle Cell Lymphoma
- Myelodysplastic Syndromes
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 3 years and 30 years
- Gender
- Both males and females
Description
All subjects will undergo allogeneic blood and marrow transplant (BMT) according to local site institutional practice. The preparative regimen will depend upon the subject's underlying disease, previous therapy, and comorbidities. GVHD prophylaxis will consist of standard post-transplant immunosuppr...
All subjects will undergo allogeneic blood and marrow transplant (BMT) according to local site institutional practice. The preparative regimen will depend upon the subject's underlying disease, previous therapy, and comorbidities. GVHD prophylaxis will consist of standard post-transplant immunosuppression, including tacrolimus (or cyclosporine) and methotrexate. Vorinostat will be administered at 30, 45 or 60 mg/m2 BID (100 mg/m2 BID maximum) PO from 10 days prior to transplant (day -10), until day +100 post-transplant (110 total days of dosing).
Tracking Information
- NCT #
- NCT03842696
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Sung W Choi, MD, MS University of Michigan
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