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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT03842696
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Acute Leukemia in Remission
  • Chronic Myelogenous Leukemia - Chronic Phase
  • Chronic Myelogenous Leukemia, Accelerated Phase
  • Chronic Myelogenous Leukemia, Blastic Phase
  • Diffuse Large B Cell Lymphoma
  • Follicular Lymphoma
  • Graft Vs Host Disease
  • Graft-versus-host-disease
  • Hematologic Diseases
  • Mantle Cell Lymphoma
  • Myelodysplastic Syndromes
  • Non Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
3 Years - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • Vorinostat — DRUG
    * 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
  • Blood and Marrow Transplant (BMT) — PROCEDURE
    Undergo allogeneic BMT according to local site institutional practice.
  • Tacrolimus (or cyclosporine) — DRUG
    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.
  • Methotrexate — DRUG
    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.
  • Mycophenolate Mofetil (MMF) — DRUG
    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.
  • Cyclophosphamide — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 4, 2020
Status verified
Jan 2026
Primary completion
Jul 30, 2025
Completion
Apr 1, 2026

Study Design

Enrollment
43 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Vorinostat

Primary Outcome Measure

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). [ Time Frame: At day +100 ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of ColoradoAuroraColorado80045-
Emory UniversityAtlantaGeorgia30322-
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202-
University of Michigan Health SystemAnn ArborMichigan48109-
Henry Ford HospitalDetroitMichigan48202-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Aurora, CO

By research site
University of Colorado· Aurora, COEmory University· Atlanta, GAIndiana University Melvin and Bren Simon Comprehensive Cancer Center· Indianapolis, INUniversity of Michigan Health System· Ann Arbor, MIHenry Ford Hospital· Detroit, MIVanderbilt-Ingram Cancer Center· Nashville, TN

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