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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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Area under the curve (AUC) of Vorinostat

Clearance (CL) of Vorinostat

GVHD-free relapse-free Survival

+10 more

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

2013

Completed Phase 4

~3800

Cyclophosphamide

1995

Completed Phase 3

~3770

Vorinostat

2014

Completed Phase 3

~1600

Mycophenolate Mofetil (MMF)

2000

Completed Phase 4

~710

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Sciences (NCATS)NIH

321 Previous Clinical Trials

401,700 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,697 Previous Clinical Trials

6,952,765 Total Patients Enrolled

University of Michigan Rogel Cancer CenterLead Sponsor

293 Previous Clinical Trials

24,048 Total Patients Enrolled

Media Library

Vorinostat (Histone Deacetylase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03842696 — Phase 1 & 2

Graft-versus-Host Disease Research Study Groups: Vorinostat

Graft-versus-Host Disease 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does your research assessment include those aged 55 and over?

"According to the requirements for enrollment, individuals aged 3 and up to 39 years old are eligible participants in this trial."

Answered by AI

What conditions are typically remedied with Blood and Marrow Transplantation (BMT)?

"ctage1 protein, human is generally treated using Blood and Marrow Transplant (BMT). This same treatment may be effective for managing psoriasis, hodgkin disease, and lymphocytic lymphomas."

Answered by AI

Who is eligible to volunteer for this trial?

"Eligible patients must be aged between 3 and 39, with a diagnosis of myelodysplastic syndromes. This trial aims to recruit up to 49 participants in total."

Answered by AI

How many participants is this clinical trial recruiting?

"That is correct. Based on the data hosted by clinicaltrials.gov, this medical trial which was initially created on February 4th 2020 is actively seeking enrolment at this time. Specifically, they are searching for 49 patients from a single centre."

Answered by AI

Could you enumerate the various investigations that have been performed in regard to Blood and Marrow Transplant (BMT)?

"Currently, 1,129 studies on Blood and Marrow Transplant (BMT) are underway with 217 in the third stage. Philadelphia, Pennsylvania is hosting most of these tests but there are 31,535 locations across the world conducting research for Blood and Marrow Transplant (BMT)."

Answered by AI

Are there vacancies available for participants of this research endeavor?

"Affirmative. Records found on clinicaltrials.gov suggest that this medical research is currently seeking volunteers; the investigation was first posted in February of 2020 and recently updated in December 2021, with a goal to recruit 49 patients from one healthcare facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vorinostat for Graft vs Host Disease Prevention in Children, Adolescents and Young Adults Undergoing Allogeneic Blood and Marrow Transplantation

2020. "Vorinostat for Graft vs Host Disease Prevention in Children, Adolescents and Young Adults Undergoing Allogeneic Blood and Marrow Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03842696.

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