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Histone Deacetylase Inhibitor

Vorinostat for Graft-versus-Host Disease Prevention

Phase 1 & 2
Recruiting
Led By Sung W Choi, MD, MS
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a drug to see if it can help prevent GVHD in kids who've had a blood or marrow transplant.

Who is the study for?
This trial is for children, adolescents, and young adults aged 3 to 39 who are undergoing allogeneic BMT for various blood cancers and diseases. They must have a matched donor, be able to take oral medication, use contraception if of reproductive age, understand consent forms in English (if participating in cognitive assessments), have a performance score of at least 70%, and expect to live more than six months.
What is being tested?
The study tests whether Vorinostat can prevent Graft vs Host Disease when added to standard prevention treatments after an allogeneic BMT. The goal is also to find the safest dose of Vorinostat for phase 2 trials in these patients.
What are the potential side effects?
Vorinostat may cause side effects like fatigue, digestive issues, changes in blood counts leading to increased infection risk or bleeding problems. Other drugs used alongside may also contribute similar side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1 portion: Determine the recommended phase 2 dose (RP2D) of the drug Vorinostat in children, adolescents, and young adults following allogeneic blood or marrow transplant (BMT).
Phase 2 portion: Incidence of grade 2-4 acute GVHD within 100 days after transplant
Secondary study objectives
Incidence of Grade 3-4 acute GVHD within 100 days after transplant
Incidence of relapse
Maximum concentration (Cmax) of Vorinostat
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: VorinostatExperimental Treatment6 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methotrexate
2019
Completed Phase 4
~4400
Cyclophosphamide
2010
Completed Phase 4
~2310
Vorinostat
2014
Completed Phase 3
~1600
Mycophenolate Mofetil (MMF)
2000
Completed Phase 4
~710

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Sciences (NCATS)NIH
377 Previous Clinical Trials
412,978 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,840 Previous Clinical Trials
8,172,574 Total Patients Enrolled
University of Michigan Rogel Cancer CenterLead Sponsor
300 Previous Clinical Trials
21,186 Total Patients Enrolled
Sung W Choi, MD, MSPrincipal InvestigatorUniversity of Michigan

Media Library

Vorinostat (Histone Deacetylase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03842696 — Phase 1 & 2
Blood Diseases Research Study Groups: Vorinostat
Blood Diseases Clinical Trial 2023: Vorinostat Highlights & Side Effects. Trial Name: NCT03842696 — Phase 1 & 2
Vorinostat (Histone Deacetylase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03842696 — Phase 1 & 2
~5 spots leftby Jun 2025
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