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NCT03842696 · ClinicalTrials.gov registry record · Phase 1
Vorinostat for Graft vs Host Disease Prevention in Children, Adolescents and Young Adults Undergoing Allogeneic Blood and Marrow Transplantation
A Phase 1 study of Myelodysplastic Syndromes and Diffuse Large B Cell Lymphoma, sponsored by University of Michigan Rogel Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
- 7
- Study locations
NCT03842696: Active Phase 1 study of Myelodysplastic Syndromes and Diffuse Large B Cell Lymphoma, sponsored by University of Michigan Rogel Cancer Center.
NCT03842696 is a Phase 1 study of Myelodysplastic Syndromes and Diffuse Large B Cell Lymphoma that is active but no longer recruiting, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 43 participants, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (85% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03842696, a Phase 1 study of Myelodysplastic Syndromes and Diffuse Large B Cell Lymphoma, is active but no longer recruiting, sponsored by University of Michigan Rogel Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
Real time assessment of safety (DLTs), and pharmacokinetic (PK) and pharmacodynamics/histone acetylation (PD) analysis in each dose cohort prior to escalation of dose. Dose de/escalation will be determined using the 3+3 up-or-down algorithm.
Conditions Studied
Interventions
- DRUG Vorinostat
- DRUG Methotrexate
- DRUG Mycophenolate Mofetil (MMF)
- PROCEDURE Blood and Marrow Transplant (BMT)
- DRUG Tacrolimus (or cyclosporine)
Study Locations (7)
Michigan
- University of Michigan Health System - Ann Arbor
- Henry Ford Hospital - Detroit
Colorado
- University of Colorado - Aurora
Georgia
- Emory University - Atlanta
Indiana
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center - Indianapolis
Tennessee
- Vanderbilt-Ingram Cancer Center - Nashville
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2020-02-04 |
| Est. Completion | 2026-04-01 |
| Phase | Phase 1 |
What the registry record for NCT03842696 still lists
NCT03842696 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (85% lower).
The record links to 10 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 5 interventions - of which Vorinostat is the first listed.
NCT03842696 lists 7 locations in 6 states (Michigan, Colorado, Georgia).
Frequently Asked Questions
What is clinical trial NCT03842696 about?
NCT03842696 is a clinical study titled "Vorinostat for Graft vs Host Disease Prevention in Children, Adolescents and Young Adults Undergoing Allogeneic Blood and Marrow Transplantation". 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 ...
What is the current status of trial NCT03842696?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2020-02-04. Estimated completion is 2026-04-01.
What conditions does trial NCT03842696 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes, Diffuse Large B Cell Lymphoma, Non-Hodgkin Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma.
What interventions are being tested in trial NCT03842696?
The interventions under investigation include: Vorinostat (DRUG), Methotrexate (DRUG), Mycophenolate Mofetil (MMF) (DRUG), Blood and Marrow Transplant (BMT) (PROCEDURE), Tacrolimus (or cyclosporine) (DRUG).
Who is sponsoring clinical trial NCT03842696?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03842696 being conducted?
This trial has 7 study locations across Colorado, Georgia, Indiana, Michigan, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03842696's enrollment target sits among peer trials
43 97th of 173 higher than 77 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes 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.
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