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

Phase 1

• Conditions: chronic phase chronic myelogenous leukaemia (CP-CML) patients in major molecular response.

• Registration Number: EUCTR2009-011675-79-FR
• Lead Sponsor: CH-Versailles

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-30
• Last Update Posted: 10 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified