A phase II study of withdrawal of imatinib therapy in adult patients with chronic phase chronic myeloid leukaemia in stable molecular remissio
- Conditions
- Chronic phase chronic myeloid leukaemia in stable molecular remissionCancer - Leukaemia - Chronic leukaemia
- Registration Number
- ACTRN12606000118505
- Lead Sponsor
- Australasian Leukaemia and Lymphoma Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
1. Diagnosis of chronic myeloid leukaemia associated with BCR-ABL quantifiable by RQ-PCR at the time of commencing imatinib therapy 2. Treatment with imatinib for at least 3 years 3. No other current or planned anti-leukaemia therapies 4. Sustained complete molecular response of leukaemia (assessed by undetectable levels of BCR-ABL by RQ-PCR in blood or marrow, for 2 years or longer, tested on at least 2 occasions per year and confirmed by the central PCR laboratory at IMVS using a technique with sensitivity of at least 4 logs) 5. No signs of extramedullary leukaemia 6. ECOG Performance status 0, 1, or 2 (see Section 6.1.2) 7. Female patients must have a negative pregnancy test within one week before starting imatinib OR have been amenorrhoeic for at least two years. All patients of reproductive potential must agree to birth control for the duration of the study monitoring and re-treatment phases. 8. Life expectancy of more than 12 months in the absence of any intervention 9. Patient has given written, informed consent to participate in the study (which includes consent to obtain samples for the correlative study) and has been given the option to participate in tissue banking.
1. Patient has received another investigational agent within last 2 years.2. Currently receiving imatinib treatment as part of a clinical trial (including Extension Phase of IRIS trial)3. Administration of cytokine therapy (e.g. G-CSF, GM-CSF or SCF) within 4 weeks prior to study entry.4. Atypical BCR-ABL transcript not quantifiable by standard RQ-PCR.5. Another primary malignant disease, except those which do not currently require treatment (adequately treated conditions, such as excised skin cancer or cervical intra-epithelial neoplasia would not be considered exclusion criteria. If in doubt, please refer to the Principal Investigator). 6. Another severe and/or life-threatening medical disease. 7. Active liver disease (e.g., chronic active hepatitis, cirrhosis).8. Known diagnosis of human immunodeficiency virus (HIV) infection. 9. History of non-compliance or inability to grant informed consent.10. Prior allogeneic stem cell transplantation11. Interruption of imatinib therapy for a cumulative period in excess of 14 days in the preceding 3 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess what proportion of CML patients with stable complete molecular response (CMR) on imatinib for at least 2 years remain in complete molecular response (without recurrence of RQ-PCR-detectable BCR-ABL in blood)[For 2 years after ceasing imatinib therapy]
- Secondary Outcome Measures
Name Time Method 1. To assess the proportion of patients who, after ceasing imatinib for up to 2 years, have recurrence of detectable BCR-ABL that is NOT eradicated within 12 months of re-starting imatinib. [];2.To assess the proportion of patients who, after ceasing imatinib for up to 2 years, have recurrence of detectable BCR-ABL but maintain a major molecular response, or regain a major molecular response or complete molecular response within 12 months of restarting imatinib.[];3.To assess the proportion of patients who develop cytogenetic or haematological relapse in the two years after cessation of imatinib[];4.To establish the rate of molecular relapse-free survival after cessation of imatinib treatment (MRFS).[];5.To assess quality of life and resolution of any identified imatinib toxicity during the period of drug withdrawal.[]