Vorinostat Plus Tacrolimus & Methotrexate to Prevent Graft vs Host Disease Following Unrelated Stem Cell Transplant

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT01790568
Phase
PHASE2
Status
Completed

Conditions

  • Graft vs Host Disease
  • Hematologic Neoplasms
  • Non-Neoplastic Hematologic and Lymphocytic Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vorinostat — DRUG
    administered at a dose of 100 mg orally, twice daily starting on day -10 in order to achieve steady-state prior to beginning the conditioning chemotherapy, and continued after transplant (day 0) until day +100.
  • Tacrolimus — DRUG
  • Methotrexate — DRUG

Study Details

This protocol, UMCC 2012.047, was a pilot study initially intended for 12 subjects. After completing enrollment of the planned 12 subjects, we are extending the study to an additional 25 subjects. The trial will examine the safety and efficacy of the addition of vorinostat, the study drug, to standard medications to try to prevent or lower the risk of graft versus-host disease (GVHD) for recipients of unrelated (matched) donor, blood or marrow stem cell transplants. The transplant regimens, chosen according to current institutional policy, will depend upon the recipients underlying disease (their blood cancer or other blood disorder), previous therapy, and current health issues. GVHD prophylaxis (preventive drug intervention) will be the local institutional standard for post-transplant immunosuppression, including tacrolimus and methotrexate, plus vorinostat. Vorinostat will be given twice daily orally beginning 10 days prior to the recipient's transplant and continue for up to 100 days after transplant.

Key Dates

Start date
Dec 31, 2014
Status verified
Jul 2018
Primary completion
Jan 1, 2017
Completion
Oct 31, 2017

Study Design

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

Arms

  • Experimental: Vorinostat
    Vorinostat, in combination with standard of care medications tacrolimus and methotrexate, for GVHD prophylaxis after unrelated donor stem cell transplant.

Primary Outcome Measure

Percentage of Patients That Experience Grade 2-4 GVHD Within 100 Days of Transplant [ Time Frame: 100 Days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Cancer CenterAnn ArborMichigan48109-

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University of Michigan Cancer Center· Ann Arbor, MI

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