Vorinostat Plus Tacrolimus & Methotrexate to Prevent Graft vs Host Disease Following Unrelated Stem Cell Transplant
Status:
Completed
Trial end date:
2017-10-31
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
University of Michigan Cancer Center University of Michigan Rogel Cancer Center