drugset
drugset / Trial / NCT01789255

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

NCT01789255 ↗

Phase 2 Completed 12 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelSupportive care

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.

Timeline

Start
2013-06
Primary completion
2014-03
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Vorinostat Small molecule — Oral
Background Cyclosporine Peptide — Intravenous
Background Methotrexate Small molecule — Intravenous
Background Tacrolimus Small molecule — Intravenous

Indications

Burkitt lymphoma Hodgkins lymphoma MALT lymphoma Waldenstrom macroglobulinemia acute myeloid leukemia with 11q23 abnormalities acute myeloid leukemia with t(8;21)(q22;q22) translocation acute myeloid leukemia, del(5q31-q32) acute myeloid leukemia, inv(16)(p13.1;q22) acute myeloid leukemia, t(15;17)(q24;q21) acute myeloid leukemia, t(16;16)(p13.1;q22) central nervous system non-hodgkin lymphoma chronic lymphocytic leukemia/small lymphocytic lymphoma chronic myelomonocytic leukemia grade III lymphomatoid granulomatosis graft versus host disease intraocular lymphoma large-cell immunoblastic lymphoma leukemia, myeloid, accelerated-phase mantle cell lymphoma myelodysplastic syndrome associated with isolated del(5q) myelodysplastic syndrome with excess blasts myelodysplastic syndrome with multilineage dysplasia myelodysplastic syndrome with ring sideroblasts myeloproliferative neoplasm, unclassifiable nodal marginal zone B-cell lymphoma post-transplant lymphoproliferative disease primary cutaneous B-cell lymphoma refractory hairy cell leukemia small intestine lymphoma splenic marginal zone lymphoma testicular lymphoma