A Phase Ib study of lenalidomide in combination with imatinib for adult patients with chronic myeloid leukaemia in second molecular remissio
- Conditions
- Chronic Myeloid Leukaemia (CML)Cancer - Leukaemia - Chronic leukaemia
- Registration Number
- ACTRN12615001169538
- Lead Sponsor
- South Australian Health & Medical Research Institute (SAHMRI)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 3
1. Diagnosis of chronic myeloid leukaemia associated with BCR-ABL quantifiable by RQ-PCR at the time of commencing imatinib therapy.
2. Patient experienced molecular recurrence of BCR-ABL during a previous medically supervised period of imatinib withdrawal, resulting in resumption of imatinib treatment, and:
a. MR4.5 at the time of having previously stopped imatinib.
b. No more than two BCR-ABL results above 0.01% in the two year period prior to having stopped imatinib.
c. Willing and able to provide all BCR-ABL RQ-PCR results from the two year period prior to having stopped imatinib, and for the period up to the time of restarting imatinib treatment.
3. Patient regained MR4.5 after restarting imatinib treatment (as detailed in criterion 3) and has maintained MR4.5 on at least 2 tests in the 12 months prior to screening, and:
a. No BCR-ABL result above 0.1% (MMR) in the 12 month period prior to screening.
b. No more than one BCR-ABL result above 0.01% in the 12 month period prior to screening.
c. Willing and able to provide copies of all BCR-ABL RQ-PCR test results from the 12 month period prior to screening.
4. Currently taking imatinib and no other current or planned anti-leukaemia therapies.
5. MR4.5 confirmed at screening.
6. No signs of extramedullary leukaemia.
7. ECOG performance status 0, 1, or 2.
8. Calculated (Cockcroft-Gault) or measured glomerular filtration rate greater than or equal to 30 mL/min
9. Female patients must have a negative pregnancy test within 24 hours before commencing lenalidomide 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.
10. Life expectancy of more than 12 months in the absence of any intervention.
11. Patient has given written, informed consent to participate in the study (which includes consent to obtain samples for the correlative studies).
1. Patient has received another investigational agent for treatment of CML within last 12 months.
2. Atypical BCR-ABL transcript not quantifiable by standard RQ-PCR.
3. Another primary malignant disease, except those which do not currently require treatment (adequately treated conditions, such as excised non-melanoma skin cancer or cervical intra-epithelial neoplasia would not be considered exclusion criteria. If in doubt, please refer to the Principal Investigator).
4. Another severe and/or life-threatening medical disease.
5. Active liver disease (e.g., chronic active hepatitis, cirrhosis).
6. History of deep venous thrombosis (in the case of clearly provoked thrombosis more than 2 years prior, please refer to the Principal Investigator).
7. Known diagnosis of human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
8. History of non-compliance or inability to grant informed consent.
9. Prior allogeneic stem cell transplantation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method