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ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

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

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

NCT03842696•University of Michigan Rogel Cancer Center

View on ClinicalTrials.gov

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.

Detailed Description

All subjects will undergo allogeneic blood or marrow transplant (BMT) according to local site institutional practice. The preparative regimen will depend upon the subject's underlying disease, type of transplant, previous therapy and comorbidities. Stem cells can be from donors of bone marrow or peripheral blood stem cells.

Eligibility

Age

3 - 39 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The donor and recipient must have an HLA-match (8/8 HLA-A, -B, -C, and -DRB1) or haploidentical match (per protocol criteria). High resolution typing is required for all alleles.
•Diagnoses to be included:
•1. Acute Leukemia in remission. Remission is defined as the absence of blasts in the peripheral circulation at the time of enrollment, \< 5% blasts in the bone marrow and absence of extramedullary disease including CNS involvement.
•2. Chronic Myeologenous Leukemia (CML) in first or subsequent chronic phase failing to respond (or intolerant) to at least two different tyrosine kinase inhibitors. CML in accelerated or blast phase (CML-AP/BP) are eligible without requirement to fail tyrosine kinase inhibitor therapy, but must be in remission at time of enrollment. Remission is defined as the absence of blasts in the peripheral circulation at the time of enrollment, \<5% blasts in the bone marrow and absence of extramedullary disease including CNS involvement.
•3. Myelodysplastic syndrome (MDS) with intermediate or high-risk IPSS or equivalent IPSSR score with \< 10% blasts in the bone marrow.
•4. Mature B Cell Malignancies (including Mantle Cell Lymphoma, Follicular Lymphoma. Diffuse Large B Cell Lymphoma, Non-Hodgkin Lymphoma not otherwise specified).Subjects should have extinguished standard of care options prior to being considered eligible for this trial
•Subjects aged 3 to 39 years
•Lansky/Karnofsky Performance Scale score of 70% or higher
•Life expectancy of greater than 6 months
•Subjects must have normal organ and marrow function (as defined in protocol)
+4 more criteria

Exclusion Criteria

•Subjects who are not a candidate for an allogeneic BMT based on the current local site institutional BMT program clinical practice guidelines. Organ function criteria will be utilized per the current local site institutional BMT program clinical practice guidelines. There will be no restriction to study entry based on hematological parameters.
•Presence of anti-donor HLA antibodies (per protocol criteria).
•Subjects who are enrolled on another GVHD treatment or prevention trial.
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat.
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Subjects still under therapy for presumed or proven infection are eligible provided there is clear evidence (radiographic findings and/or culture results) that the infection is well-controlled. Subjects under treatment for infection will be enrolled only after clearance from the PI.
•Pregnant women are excluded from this study because vorinostat is a histone deacetylase inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with vorinostat, breastfeeding should be discontinued if the mother is treated with vorinostat. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
•Subjects with evidence of HIV seropositivity and/or positive PCR assay, HTLV1/HTLV2 seropositivity. The safety of allogeneic HSCT is not yet well-established for this population.
•Subjects with evidence of Hepatitis B or Hepatitis C PCR positivity. Hepatitis reactivation following myelosuppressive therapy can lead to fatal complications.
•Subjects with a history of prolonged QTc syndrome.
•Subjects who have had prior treatment with a drug like vorinostat (i.e., valproic acid) within the last 30 days.
+1 more criteria

Locations (7)

University of Colorado

Aurora, Colorado, United States

Emory University

Atlanta, Georgia, United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Key Dates

Start Date

February 4, 2020

Primary Completion Date

July 30, 2025

Completion Date

April 1, 2026

Last Updated

January 27, 2026

Enrollment

ACTUAL participants

Conditions

Hematologic DiseasesAcute Leukemia in RemissionChronic Myelogenous Leukemia - Chronic PhaseChronic Myelogenous Leukemia, Accelerated PhaseChronic Myelogenous Leukemia, Blastic PhaseMyelodysplastic SyndromesMantle Cell LymphomaFollicular LymphomaDiffuse Large B Cell LymphomaNon Hodgkin LymphomaGraft Vs Host DiseaseGraft-versus-host-disease

Interventions

Vorinostat

DRUG

Blood and Marrow Transplant (BMT)

PROCEDURE

Tacrolimus (or cyclosporine)

DRUG

Methotrexate

DRUG

Mycophenolate Mofetil (MMF)

DRUG

Cyclophosphamide

DRUG

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RECRUITING

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Hematologic Diseases

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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