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ACTIVE NOT RECRUITING
NCT03842696
PHASE1/PHASE2

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

Sponsor: 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.

Official title: 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

Key Details

Gender

All

Age Range

3 Years - 39 Years

Study Type

INTERVENTIONAL

Enrollment

43

Start Date

2020-02-04

Completion Date

2026-04-01

Last Updated

2026-01-27

Healthy Volunteers

No

Interventions

DRUG

Vorinostat

* HLA-matched BMT recipients: Vorinostat 30, 45 or 60 mg/m2 BID (100 mg/m2 BID maximum) PO from 10 days prior to transplant (day -10), until day +30 post-transplant. * Haploidentical BMT recipients: Vorinostat 30, 45 or 60 mg/m2 BID (100 mg/m2 BID maximum) PO from 5 days after transplant (day +5), until day +30 post-transplant

PROCEDURE

Blood and Marrow Transplant (BMT)

Undergo allogeneic BMT according to local site institutional practice.

DRUG

Tacrolimus (or cyclosporine)

Tacrolimus (or cyclosporine if tacrolimus becomes in shortage during the study period) will begin on day -3. Intravenous or oral dosing is permitted.In the absence of GVHD, it is recommended that tacrolimus or cyclosporine tapering begin on day +100 post-transplant as per local site BMT program clinical practice guidelines. In the presence of GVHD, it is recommended that tacrolimus or cyclosporine be continued at therapeutic dosing.

DRUG

Methotrexate

HLA-matched BMT recipients: Methotrexate will be used in combination with tacrolimus (or cyclosporine) for standard GVHD prophylaxis. It will be given at a dose of 5 mg/m2/dose once daily intravenously on days +1, +3, +6, and +11. Standard criteria for administration will be followed per local site institutional BMT program clinical practice guidelines.

DRUG

Mycophenolate Mofetil (MMF)

Haploidentical BMT recipients: MMF will be used in combination with post-transplant cyclophosphamide and tacrolimus (or cyclosporine) for standard GVHD prophylaxis. MMF will start on day +5 and discontinue after the last dose on day +35 or may be continued if active GVHD is present. Given intravenously (preferred) or orally at a dose of 15 mg/kg/dose three times a day (based upon adjusted body weight) with the maximum total daily dose not to exceed 3 grams.

DRUG

Cyclophosphamide

Haploidentical BMT recipients: Post-transplant cyclophosphamide (PT-Cy) will be used in combination with MMF and tacrolimus (or cyclosporine) for standard GVHD prophylaxis. PT-Cy (50 mg/kg/dose) given for two days, Days +3 and +4 after transplantation.

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