chronic phase chronic myelogenous leukaemia (CP-CML) patients in major molecular response.
Conditions
Interventions
Trade Name: ACTOS 15 mg
Product Name: PIOGLITAZONE HYDROCHLORIDE
Pharmaceutical Form: Tablet
Sponsors
CH-Versailles
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, 2. Participation in another clinical trial with any investigative drug within 30 days prior to study enrolment, 3. Prior history of hématopoietic stem cell transplantation (autologous or allogenic) 4. Patient requiring anti-diabetic medication 5. Cardiovascular disease: • Stage I to IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA) classification system for heart failure. Note: patients with NYHA • Myocardial infarction within the previous 6 months • Symptomatic cardiac arrhythmia requiring treatment 6. Grade III or IV fluid retention 7. Known osteoporosis with therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of pioglitazone therapy in combination with imatinib in CML patients with residual molecular disease after imatinib monotherapy.;Secondary Objective: A. To determine the safety of pioglitazone therapy in combination with imatinib B. To assess the biological activity of the combination in vivo C. To investigate the relationship between biological activity and efficacy of the combination D. To determine the duration of effect in term of molecular response E. To document the rate of progression free survival and overall survival. F. To discontinue therapy in patients in complete molecular response for 2 years after the initiation of pioglitazone. ;Primary end point(s): The rate of patients achieving a complete molecular response (Sensitivity 10-5 or Bcr-Abl/Abl ratio < 0.001 %) 24 weeks after the initiation of pioglitazone, confirmed on by a second determination 2 months later. | — |
Countries
France
Outcome results
None listed