drugset / Trial / NCT01132573

Entinostat and Clofarabine in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Poor-Risk Acute Lymphoblastic Leukemia or Bilineage/Biphenotypic Leukemia

NCT01132573

Phase 1 Completed 27 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

This phase I trial studies the side effects and best dose of entinostat when given together with clofarabine in treating patients with newly diagnosed, relapsed, or refractory poor-risk acute lymphoblastic leukemia or bilineage/biphenotypic leukemia. Entinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving entinostat with clofarabine may kill more cancer cells.

Timeline

Start
2010-04
Primary completion
2014-06
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Clofarabine Other / unclassified 10 mg/m2 Intravenous
Subject Entinostat Small molecule 4 mg Oral
Subject Entinostat Small molecule 6 mg Oral
Subject Entinostat Small molecule 8 mg Oral