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

Bristol-Myers Squibb (BMS)

Status and phase

Terminated

Phase 3

Conditions

Leukemia

Treatments

Drug: Dasatinib

Drug: Imatinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00362466

CA180-044

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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