drugset / Trial / NCT00844298

Nilotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

NCT00844298

Phase 2 Completed 91 enrolled Asan Medical Center
NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving nilotinib together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving nilotinib together with combination chemotherapy works in treating patients with newly diagnosed acute lymphoblastic leukemia.

Timeline

Start
2009-01
Primary completion
2012-06
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Nilotinib Small molecule 400 mg Oral
Background Cytarabine Small molecule 2000 mg/m2 Intravenous
Background Daunorubicin Small molecule 45 mg/m2 Intravenous
Background Daunorubicin Small molecule 90 mg/m2 Intravenous
Background Etoposide Small molecule 150 mg/m2 Intravenous
Background Leucovorin Small molecule 50 mg/m2 Intravenous
Background Methotrexate Small molecule 60 mg/m2 Intravenous
Background Prednisolone Other / unclassified 60 mg/m2 Oral
Background Vincristine Small molecule 2 mg Intravenous

Indications