drugset / Trial / NCT00258271

Cladribine, Cytarabine, and Imatinib Mesylate in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Blastic Phase Chronic Myelogenous Leukemia

NCT00258271

Phase 1 Completed 18 enrolled University of Rochester
Treatment

Summary

RATIONALE: Drugs used in chemotherapy, such as cladribine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cladribine and cytarabine together with imatinib mesylate may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate when given together with cladribine and cytarabine in treating patients with refractory or relapsed acute myeloid leukemia or blastic phase chronic myelogenous leukemia.

Timeline

Start
2005-03
Primary completion
2006-10
Completion
2006-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Imatinib Small molecule 400 mg Oral
Subject Imatinib Small molecule 600 mg Oral
Subject Imatinib Small molecule 800 mg Oral
Background Cladribine Small molecule 5 mg/m2 Intravenous
Background Cytarabine Small molecule 2 g Intravenous
Background filgrastim Protein / enzyme biologic 300 ug Subcutaneous

Indications