Chronic Myeloid Leukemia, BCR-ABL1 Positive Clinical Trial
Official title:
A Phase IIb Study of Molecular Responses to Imatinib, at Standard or Increased Doses, or Dasatinib (BMS-354825) (NSC-732517) for Previously Untreated Patients With Chronic Myelogenous Leukemia (CML) in Chronic Phase
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.
PRIMARY OBJECTIVES: I. To compare the molecular response rates, as measured by the decrease in breakpoint cluster region-Abelson murine leukemia viral oncogene homolog 1 (BCR-ABL) transcripts after 12 months of treatment, in patients with previously untreated chronic myelogenous leukemia (CML) in chronic phase who are treated with either dasatinib 100 mg/day or imatinib (STI571, Gleevec) (imatinib mesylate) 400 mg/day. II. To test whether increasing the dose of imatinib (STI571, Gleevec®) from 400 mg/day to 800 mg/day increases the rate of molecular response, as measured by the decrease in BCR-ABL transcripts after 12 months of treatment, in patients with previously untreated CML in chronic phase. III. To estimate rates of cytogenetic and hematologic responses to imatinib 400 mg/day, imatinib 800 mg/day, and dasatinib 100 mg/day. IV. To evaluate in a preliminary manner the prognostic effects of derivative (der)(9) and der(22) chromosomal deletions for response in CML patients treated with imatinib and dasatinib. V. To investigate in a preliminary manner changes in gene expression at relapse or progression compared to pre-treatment. VI. To estimate the frequency and severity of toxicities of the three treatment regimens. VII. To evaluate, in a preliminary manner, the overall survival and relapse-free survival of patients treated with these regimens. OUTLINE: Patients are randomized to 1 of 3 treatment arms. ARM I: Patients receive imatinib mesylate orally (PO) once daily (QD). Treatment repeats every 4 weeks for up to 5 years in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive imatinib mesylate PO twice daily (BID). Treatment repeats every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity. ARM III: Patients receive dasatinib PO BID. Treatment repeats every 4 weeks for up to 5 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 15 years. ;