A Study of Dasatinib vs. High-Dose Imatinib (600 mg) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML) Who Failed to Achieve Complete Cytogenetic Response After 3-18 Months of Imatinib Therapy

Stopped early · Phase 3

Conditions studied: Leukemia

In brief

The purpose of this clinical research study is to compare the rate of complete cytogenetic response of dasatinib to imatinib therapy at 6 months after randomization in chronic phase CML patients. The safety of this treatment will also be studied.

Key facts

Study ID

NCT00362466

Run by

Bristol-Myers Squibb

People needed

3

Starts

2007-04-01

Expected to finish

2008-06-01

Last updated by the study team

2009-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women ≥18 years diagnosed with Chronic Phase Philadelphia chromosome positive (CP Ph+) CML who have failed to achieve CCyR after 3-18 months of therapy with imatinib 400 mg
• Treatment initiation with imatinib 400 mg within 6 months of initial CML diagnosis
• Able to tolerate chronic administration of imatinib at the highest dose (400-600 mg) the subject has received in the past
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2
• Adequate hepatic and renal function

You may not qualify if…

• Eligible and willing to undergo immediate autologous/allogeneic stem cell transplant
• Previous diagnosis of accelerated/blast crisis CML
• Subjects with clonal evolution in Ph+ cells observed in ≥2 metaphases
• Previous documentation of T315I mutation
• Uncontrolled or significant cardiovascular disease
• Serious uncontrolled medical disorder/active infection
• History of significant bleeding disorder unrelated to CML
• Intolerance to imatinib ≥400 mg
• Concurrent malignancies other than CML

Where it is running

• Dr. Marshall Schreeder — Huntsville, Alabama, United States
• Local Institution — Little Rock, Arkansas, United States
• Local Institution — Alhambra, California, United States
• Local Institution — Anaheim, California, United States
• Local Institution — Beverly Hills, California, United States
• Local Institution — Fullerton, California, United States
• Local Institution — La Jolla, California, United States
• Local Institution — La Verne, California, United States
• Local Institution — Long Beach, California, United States
• Local Institution — Los Angeles, California, United States
• Local Institution — Los Angeles, California, United States
• Local Institution — Los Angeles, California, United States
• Local Institution — Northridge, California, United States
• Local Institution — Oxnard, California, United States
• Local Institution — Redondo Beach, California, United States
• Local Institution — San Francisco, California, United States
• Local Institution — Santa Maria, California, United States
• Local Institution — Stanford, California, United States
• Local Institution — Aurora, Colorado, United States
• Local Institution — Jacksonville, Florida, United States
• Local Institution — Jacksonville, Florida, United States
• M.D. Anderson Cancer Center Orlando — Orlando, Florida, United States
• Local Institution — Pembroke Pines, Florida, United States
• Local Institution — Chicago, Illinois, United States
• Local Institution — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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