Imatinib Mesylate or Dasatinib in Treating Patients With Previously Untreated Chronic Phase Chronic Myelogenous Leukemia
Condition: Chronic Myeloid Leukemia, BCR-ABL1 Positive
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Intervention: Dasatinib; Imatinib Mesylate; Laboratory Biomarker Analysis
Intervention description: Given PO; Given PO; Correlative studies
Intervention MeSH terms: Imatinib Mesylate; Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 406.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have CML in chronic phase based on bone marrow aspiration and biopsy and
             peripheral blood counts obtained within 28 days before registration

          -  Patients must be registered on this study within 180 days after the date of first
             being diagnosed with CML, based on a cytogenetic or molecular analysis of peripheral
             blood or bone marrow, demonstrating the presence of the Philadelphia chromosome or
             variants of the (9;22) translocation or testing positive for Bcr-Abl by real
             time-polymerase chain reaction (RT-PCR); patients may have secondary chromosomal
             abnormalities in addition to the Philadelphia chromosome and remain eligible

          -  Patients must have Zubrod performance status 0-2

          -  Patients must not have received prior treatment for CML with the exception of
             hydroxyurea and/or anagrelide

          -  Patients must not have received any prior chemotherapy regimen for peripheral blood
             stem cell mobilization; (prior collection of unmobilized peripheral blood stem cells
             is permitted)

          -  Serum bilirubin =< 2.0 x the institutional upper limit of the normal (IULN)

          -  Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) or
             serum glutamate pyruvate transaminase (SGPT)/alanine transaminase (ALT) =< 2.0 x the
             IULN

          -  Patients (Southwestern Oncology Group [SWOG] institutions only) must be registered on
             SWOG-9007, "Cytogenetic Studies in Leukemia Patients;" collection of the pretreatment
             bone marrow specimen must be completed within 28 days prior to registration; the
             pretreatment bone marrow specimen must be submitted to an approved Southwest Oncology
             Group Cytogenetics Laboratory for cytogenetic analysis as described, and an aliquot of
             the bone marrow (or peripheral blood if the marrow aspiration is a dry tap) must be
             submitted for fluorescent in situ hybridization (FISH) analysis; note that protocol
             SWOG-9007 also requires submission of bone marrow specimens at the time of progression
             to the accelerated or blastic phase of CML or the loss of complete hematologic
             response and every six months while the patient is on this study

          -  Patients (SWOG institutions only) must be registered on S9910, "Leukemia Centralized
             Reference Laboratories and Tissue Repositories, Ancillary;" specimens of peripheral
             blood and bone marrow must be submitted to the Southwest Oncology Group Lymphoid
             Leukemia and CML Centralized Laboratory in Seattle, Washington; collection of
             pretreatment blood and marrow specimens must be completed within 28 days prior to
             registration; note that this study also requires submission of peripheral blood and
             bone marrow specimens at various times after entry into the study

          -  Patients must not have undergone major surgery within 28 days before registration, and
             must have fully recovered from any other prior major surgery

          -  Patients must not be pregnant or nursing; women/men of reproductive potential must
             have agreed to use an effective contraceptive method

          -  No other prior malignancy is allowed except for the following: adequately treated
             basal cell or squamous cell skin cancer, cervical carcinoma in situ, adequately
             treated stage I or II cancer from which the patient is currently in complete
             remission, or any other cancer from which the patient has been disease-free for five
             years

          -  Patients must have an electrocardiogram (ECG) within 42 days prior to registration,
             and must not have any of the following cardiac symptoms prior to entry on study:

               -  Uncontrolled angina, congestive heart failure or myocardial infarction (MI)
                  within 6 months of study entry

               -  Diagnosed or suspected congenital long QT syndrome

               -  Any history of clinically significant ventricular arrhythmias (such as
                  ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)

               -  Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (> 450 msec)

               -  Uncontrolled hypertension

          -  Patients must not have a history of significant bleeding disorder unrelated to cancer,
             including:

               -  Congenital bleeding disorders (e.g., von Willebrand's disease)

               -  Acquired bleeding disorder within one year (e.g., acquired anti-factor VIII
                  antibodies)

          -  All patients must be informed of the investigational nature of this study and must
             sign and give written informed consent in accordance with institutional and federal
             guidelines

          -  At the time of patient registration, the treating institution's name and
             identification (ID) number must be provided to the Data Operations Center in Seattle
             in order to ensure that the current (within 365 days) date of institutional review
             board approval for this study has been entered into the data base