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
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Keep this study
Lead
Bristol-Myers Squibb
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | 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
