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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year
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 moreAwards & 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
369 Previous Clinical Trials
412,815 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,817 Previous Clinical Trials
8,161,710 Total Patients Enrolled
University of Michigan Rogel Cancer CenterLead Sponsor
300 Previous Clinical Trials
24,316 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have any serious illnesses or social situations that would stop me from following the study's requirements.I am not pregnant or breastfeeding, and will not become pregnant during the study.I am HIV positive or have HTLV1/HTLV2.I have a history of prolonged QTc syndrome.I haven't taken drugs like vorinostat in the last 30 days.I have tested positive for Hepatitis B or C.I am a candidate for a bone marrow transplant from a donor for my blood cancer.My brain-related disease is currently in remission.My donor and I are a complete or half HLA match.I am not eligible for a bone marrow transplant according to my hospital's guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Vorinostat
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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