drugset / Trial / NCT02083250

Fludarabine Phosphate, Clofarabine, and Busulfan With Vorinostat in Treating Patients With Acute Leukemia in Remission or Relapse Undergoing Donor Stem Cell Transplant

NCT02083250

NaSingle-groupOpen-labelTreatment

Summary

This phase I trial studies the side effects and best dose of vorinostat when given together with fludarabine phosphate, clofarabine, and busulfan in treating patients with acute leukemia that is under control (remission) or has returned (relapse) undergoing donor stem cell transplant. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine phosphate, clofarabine, and busulfan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving vorinostat together with fludarabine phosphate, clofarabine, and busulfan before a donor stem cell transplant may be a better treatment for patients with acute leukemia.

Timeline

Start
2014-03-06
Primary completion
2021-11-12
Completion
2021-11-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Vorinostat Small molecule Oral
Background ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) Protein / enzyme biologic Intravenous
Background Busulfan Small molecule Intravenous
Background Clofarabine Other / unclassified Intravenous
Background Fludarabine Small molecule Intravenous