Comparison of Imatinib Versus Dasatinib in Patients With Newly-diagnosed Chronic Phase Chronic Myeloid Leukaemia

Launched by NEWCASTLE UNIVERSITY · Oct 26, 2011

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Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female patients 18 years or over.
• 2. Patients must have all of the following:
• • be enrolled within 3 months of initial diagnosis of CML-CP (date of initial diagnosis is the date of first cytogenetic analysis)
• • cytogenetic confirmation of the Philadelphia chromosome or variants of (9;22) translocations
• • patients may have secondary chromosomal abnormalities in addition to the Philadelphia chromosome.
• • \< 15% blasts in peripheral blood and bone marrow;
• • \< 30% blasts plus promyelocytes in peripheral blood and bone marrow;
• • \< 20% basophils in peripheral blood,
• • 100 x 109/L platelets or greater
• • no evidence of extramedullary leukaemic involvement, with the exception of the hepatosplenomegaly.
• • 3. Written voluntary informed consent.
• Exclusion Criteria:
• • 1. Patients with Ph-negative, BCR-ABL-positive, disease are NOT eligible for the study.
• • 2. Any prior treatment for CML with: any tyrosine kinase inhibitor (eg imatinib, dasatinib); busulphan; interferon-alpha; homoharringtonine; cytosine arabinoside; any other investigational agents (hydroxycarbamide and anagrelide are the only drugs permitted). NB patients will be ineligible for the study if they have received ANY prior therapy with interferon-alpha or imatinib. NO exceptions.
• • 3. Patients who received prior chemotherapy, including regimens used in peripheral blood progenitor cells (PBPCs) mobilisation for haematopoietic progenitor-cell transplantation. (It is allowable to collect unmobilised PBPCs at diagnosis.)
• • 4. Patient who have had any form of prior haemopoietic stem cell transplant, either autograft or allograft.
• • 5. Patients with an ECOG Performance Status Score of 2 or less.
• • 6. Patients with serum bilirubin, SGOT/AST, SGPT/ALT, or creatinine concentrations \> 2.0 x the institutional upper limit of the normal range (IULN).
• • 7. Patients with International normalized ratio (INR) or partial thromboplastin time (PTT) \> 1.5 x IULN, with the exception of patients on treatment with oral anticoagulants.
• • 8. Patients with uncontrolled medical disease such as diabetes mellitus, thyroid dysfunction, neuropsychiatric disorders, infection, angina, or Grade 3/4 cardiac problems as defined by the New York Heart Association Criteria.
• • 9. Patients with known positivity for human immunodeficiency virus (HIV); baseline testing for HIV is not required.
• • 10. Patients who have undergone major surgery within 4 weeks of Study Day 1, or who have not recovered from prior major surgery.
• 11. Patients who are:
• • pregnant,
• • breast feeding,
• • of childbearing potential without a negative pregnancy test prior to Study Day 1, and
• • male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).
• • 12. Patients with a history of another malignancy either currently or within the past five years, with the exception of basal cell skin carcinoma or cervical carcinoma in situ.
• • 13. Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable.