Status:
COMPLETED
Comparison of Imatinib Versus Dasatinib in Patients With Newly-diagnosed Chronic Phase Chronic Myeloid Leukaemia
Lead Sponsor:
Newcastle University
Collaborating Sponsors:
Newcastle-upon-Tyne Hospitals NHS Trust
Bristol-Myers Squibb
Conditions:
Myeloid Leukemia, Chronic, Chronic Phase
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Imatinib 400mg daily is the current NICE-approved standard treatment for newly diagnosed Chronic Myeloid Leukaemia (CML). 5 yr follow up of CML patients treated in this way indicates an 89% probabilit...
Eligibility Criteria
Inclusion
- Male or female patients 18 years or over.
- 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.
- Written voluntary informed consent.
Exclusion
- Patients with Ph-negative, BCR-ABL-positive, disease are NOT eligible for the study.
- 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.
- 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.)
- Patient who have had any form of prior haemopoietic stem cell transplant, either autograft or allograft.
- Patients with an ECOG Performance Status Score of 2 or less.
- Patients with serum bilirubin, SGOT/AST, SGPT/ALT, or creatinine concentrations \> 2.0 x the institutional upper limit of the normal range (IULN).
- 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.
- 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.
- Patients with known positivity for human immunodeficiency virus (HIV); baseline testing for HIV is not required.
- Patients who have undergone major surgery within 4 weeks of Study Day 1, or who have not recovered from prior major surgery.
- 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).
- 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.
- Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2018
Estimated Enrollment :
814 Patients enrolled
Trial Details
Trial ID
NCT01460693
Start Date
August 1 2008
End Date
March 7 2018
Last Update
April 24 2018
Active Locations (1)
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1
Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE7 7DN