CHRONIC PHASE CHRONIC MYELOGENOUS LEUKAEMIA
Conditions
Brief summary
Safety: To describe adverse events (AE) in subjects receiving the combination of PIO and TKI. AEs will be graded ac cording to the Common Terminology Criteria for Adverse Events (CTCAE) v.4.03 assessed through scheduled assessment and subject reported diary. To evaluate the pharmacokinetic parameters of pioglitazone and TKIs., Efficacy : To determine the proportion of subjects who maintain MMR over a 12 months period following discontinuation of PIO and TKI using blood qRT-PCR for BCR-ABL1 obtained monthly for the first 6 months, quarterly following 6 months, and bi-annually the second year, thereafter , in accordance of the center policy.
Interventions
Sponsors
Centre Hospitalier De Versailles, Centre Hospitalier De Versailles
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: To describe adverse events (AE) in subjects receiving the combination of PIO and TKI. AEs will be graded ac cording to the Common Terminology Criteria for Adverse Events (CTCAE) v.4.03 assessed through scheduled assessment and subject reported diary. To evaluate the pharmacokinetic parameters of pioglitazone and TKIs., Efficacy : To determine the proportion of subjects who maintain MMR over a 12 months period following discontinuation of PIO and TKI using blood qRT-PCR for BCR-ABL1 obtained monthly for the first 6 months, quarterly following 6 months, and bi-annually the second year, thereafter , in accordance of the center policy. | — |
Countries
France
Outcome results
None listed