Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
A Pilot Trial of Vorinostat Plus Tacrolimus and Methotrexate to Prevent Graft Versus Host Disease Following Unrelated Donor Hematopoietic Stem Cell Transplantation
This pilot phase II trial studies how well giving vorinostat, tacrolimus, and methotrexate works in preventing graft-versus-host disease (GVHD) after stem cell transplant in patients with hematological malignancies. Vorinostat, tacrolimus, and methotrexate may be an effective treatment for GVHD caused by a bone marrow transplant.
PRIMARY OBJECTIVES:
I. To assess the safety and the feasibility of the addition of vorinostat to tacrolimus and
methotrexate GVHD prophylaxis.
SECONDARY OBJECTIVES:
I. To determine day 100 grades 2-4 acute GVHD. II. To determine 1-year overall survival and
relapse-free survival. III. To correlate plasma concentrations of inflammatory markers of
acute GVHD. IV. To correlate protein acetylation in peripheral blood mononuclear cells before
and after administration of vorinostat.
OUTLINE:
Patients receive vorinostat orally (PO) twice daily (BID) on days -10 to 100. Beginning on
day -3, patients receive tacrolimus intravenously (IV) continuously or PO BID (or
cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on
days 100-180.Patients also receive methotrexate IV once daily (QD) on days 1, 3, 6, and 11.
After completion of study treatment, patients are followed up periodically for 1 year.
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