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This study examined the effect of adding Pioglitazone to Imatinib treatment in patients with chronic myeloid leukemia (CML). It included patients aged 18 and older with Philadelphia chromosome-positive chronic-phase CML who had been on Imatinib for at least 2 years and achieved a major molecular response. It was conducted in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. Patient aged 18y or more 2. Signed informed consent 3. Patient with Philadelphia chromosome positive chronic phase CML and M BCR-ABL transcript positivity 4. Treatment with imatinib for more than 2 years 5. No dose modification of imatinib within the last 3 months 6. Complete cytogenetic response on the last cytogenetic analysis within the last 12 months 7. Major molecular remission without complete molecular remission 8. ECOG grade 0 to 2 9. SGOT et SGPT ≤ 2.5 N 10. Bilirubin in serum ≤ 1.5 N 11. Women of childbearing potential (WOCBP) must be using an adequate method of contraception Exclusion Criteria: 1. Participation in another clinical trial with any investigative drug within 30 days prior to study enrollment 2. Prior history of hematopoietic stem cell transplantation (autologous or allogenic) 3. Patient requiring anti-diabetic medication 4. Cardiovascular disease: * Stage I to IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA) classification system for heart failure * Myocardial infarction within the previous 6 months * Symptomatic cardiac arrhythmia requiring treatment 5. Grade III or IV fluid retention 6. Known osteoporosis with therapy