Imatinib Mesylate or Dasatinib in Treating Patients With Previously Untreated Chronic Phase Chronic Myelogenous Leukemia

Phase 2 Active not recruiting 406 enrolled National Cancer Institute (NCI)

RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase IIB trial studies imatinib mesylate at two different doses and dasatinib to see how well they work in treating patients with previously untreated chronic phase chronic myelogenous leukemia. Imatinib mesylate or dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Timeline

Start: 2004-08-15
Primary completion: 2010-11-01
Completion: 2027-03-10

Outcome

Missed primary endpoint

registry analysis (unspecified test); Dasatinib vs Standard Dose Imatinib B; p = 0.31; Fisher Exact NCT00070499 ↗

Publications

Radich JP, Kopecky KJ, Appelbaum FR, Kamel-Reid S, Stock W, Malnassy G, Paietta E, Wadleigh M, Larson RA, Emanuel P, Tallman M, Lipton J, Turner AR, Deininger M, Druker BJ. A randomized trial of dasatinib 100 mg versus imatinib 400 mg in newly diagnosed chronic-phase chronic myeloid leukemia. Blood. 2012 Nov 8;120(19):3898-905. doi: 10.1182/blood-2012-02-410688. Epub 2012 Aug 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Imatinib	Small molecule	400 mg	Oral
Subject	Imatinib	Small molecule	800 mg	Oral
Subject	dasatinib anhydrous	Small molecule	100 mg	Oral