Clinical Trial: NCT03842696
Vorinostat for Graft vs Host Disease Prevention in Children, Adolescents and Young Adults Undergoing Allogeneic Blood and Marrow Transplantation
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 1| Lead Sponsor: | University of Michigan Rogel Cancer Center |
| Information Provided By: | University of Michigan Rogel Cancer Center |
| Last Update Posted: | 2026-01-27 |
Study Overview
Brief Summary
The purpose of this study is to determine the recommended phase 2 dose of the drug Vorinostat in children, adolescents and young adults following allogeneic blood or marrow transplant (BMT) and determine whether the addition of Vorinostat to the standard graft versus host disease (GVHD) prophylaxis will reduce the incidence of GVHD.
Official Title
A Phase 1/2 Multi-Center Trial of Vorinostat for Graft vs Host Disease Prevention in Children, Adolescents and Young Adults Undergoing Allogeneic Blood and Marrow Transplantation
Conditions
Hematologic Diseases, Acute Leukemia in Remission, Chronic Myelogenous Leukemia - Chronic Phase, Chronic Myelogenous Leukemia, Accelerated Phase, Chronic Myelogenous Leukemia, Blastic Phase, Myelodysplastic Syndromes, Mantle Cell Lymphoma, Follicular Lymphoma, Diffuse Large B Cell Lymphoma, Non Hodgkin Lymphoma, Graft Vs Host Disease, Graft-versus-host-disease
Intervention / Treatment
- Drug: Vorinostat
- Procedure: Blood and Marrow Transplant (BMT)
- Drug: Tacrolimus (or cyclosporine)
- Drug: Methotrexate
- Drug: Mycophenolate Mofetil (MMF)
- Drug: Cyclophosphamide
Other Study ID Numbers
- UMCC 2018.081
- HUM00147796
- HUM00186659
- UL1TR002240
Start Date (Actual)
2020-02-04
Primary Completion Date (Actual)
2025-07-30
Study Completion Date (Estimated)
2026-04-01
Enrollment (Actual)
43
Study Type
Interventional
Phase
Phase 1, Phase 2
| Lead Sponsor: | University of Michigan Rogel Cancer Center |
| Information Provided By: | University of Michigan Rogel Cancer Center |
| Last Update Posted: | 2026-01-27 |
Study Overview
Brief Summary
The purpose of this study is to determine the recommended phase 2 dose of the drug Vorinostat in children, adolescents and young adults following allogeneic blood or marrow transplant (BMT) and determine whether the addition of Vorinostat to the standard graft versus host disease (GVHD) prophylaxis will reduce the incidence of GVHD.
Official Title
A Phase 1/2 Multi-Center Trial of Vorinostat for Graft vs Host Disease Prevention in Children, Adolescents and Young Adults Undergoing Allogeneic Blood and Marrow Transplantation
Conditions
Hematologic Diseases, Acute Leukemia in Remission, Chronic Myelogenous Leukemia - Chronic Phase, Chronic Myelogenous Leukemia, Accelerated Phase, Chronic Myelogenous Leukemia, Blastic Phase, Myelodysplastic Syndromes, Mantle Cell Lymphoma, Follicular Lymphoma, Diffuse Large B Cell Lymphoma, Non Hodgkin Lymphoma, Graft Vs Host Disease, Graft-versus-host-disease
Intervention / Treatment
- Drug: Vorinostat
- Procedure: Blood and Marrow Transplant (BMT)
- Drug: Tacrolimus (or cyclosporine)
- Drug: Methotrexate
- Drug: Mycophenolate Mofetil (MMF)
- Drug: Cyclophosphamide
Other Study ID Numbers
- UMCC 2018.081
- HUM00147796
- HUM00186659
- UL1TR002240
Start Date (Actual)
2020-02-04
Primary Completion Date (Actual)
2025-07-30
Study Completion Date (Estimated)
2026-04-01
Enrollment (Actual)
43
Study Type
Interventional
Phase
Phase 1, Phase 2