Trials / Completed

CompletedNCT01789255

Vorinostat, Tacrolimus, and Methotrexate in Preventing GVHD After Stem Cell Transplant in Patients With Hematological Malignancies

A Pilot Trial of Vorinostat Plus Tacrolimus and Methotrexate to Prevent Graft Versus Host Disease Following Unrelated Donor Hematopoietic Stem Cell Transplantation

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 12 (actual)

Sponsor: National Cancer Institute (NCI) · NIH
Sex: All
Age: 18 Years – 75 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

Type	Name	Description
DRUG	vorinostat	Given PO
DRUG	tacrolimus	Given IV or PO
DRUG	cyclosporine	Given IV or PO
DRUG	methotrexate	Given IV
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies

Timeline

Start date: 2013-06-01
Primary completion: 2014-03-01
Completion: 2014-03-01
First posted: 2013-02-12
Last updated: 2018-07-24
Results posted: 2015-11-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01789255. Inclusion in this directory is not an endorsement.