CML V - chronic phase Chronic Myeloid Leukaemia
- Conditions
- eukaemiaCancerMyeloid leukaemia
- Registration Number
- ISRCTN68784584
- Lead Sponsor
- niversity of Oxford (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 800
1. Newly diagnosed, previously untreated CML in chronic phase (therapeutic or back up leucapheresis does not preclude entry to the trial. Patients may be started on hydroxyurea for up to 4 weeks before randomisation)
2. The presence of the Ph chromosome or molecular evidence of Breakpoint Cluster Region (BCR)/Abelson (ABL) re-arrangement
3. World Health Organisation (WHO) performance status is 0./1, or 2 4. There is informed consent in accordance with MRC requirements and that of local ethics committees
5. Adequate hepatic and renal functions defined by bilirubin and creatinine levels below twice the upper limit. The possibility of allogeneic Bone Marrow Transplant (BMT) does not preclude entry to the trial
1. Received previous treatment for CML
2. WHO performance status 3 or 4
3. Accelerated phase or established blast crisis; severe concurrent hepatic, renal or cardio-vascular problems or a history of severe depression in the past
4. Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Overall survival<br>2. Frequency of haematologic and cytogenetic response<br>3. Duration of chronic phase and overall survival<br>4. Toxicity profiles<br>5. Side effects<br>6. Performance status<br>7. Quality of life
- Secondary Outcome Measures
Name Time Method ot provided at time of registration