EUCTR2009-011675-79-FR
Active, not recruiting
Phase 1
A PHASE II STUDY TO ASSESS EFFICACY AND SAFETY OF PIOGLITAZONE (ACTOS®) AS ADD-ON THERAPY TO IMATINIB MESYLATE (GLEEVEC®) IN CHRONIC PHASE CHRONIC MYELOGENOUS LEUKAEMIA (CP-CML) PATIENTS IN MAJOR MOLECULAR RESPONSE (MMR). - ACTIM
CH-Versailles0 sites50 target enrollmentApril 30, 2009
Conditionschronic phase chronic myelogenous leukaemia (CP-CML) patients in major molecular response.
DrugsACTOS 15 mg
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- chronic phase chronic myelogenous leukaemia (CP-CML) patients in major molecular response.
- Sponsor
- CH-Versailles
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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