Pioglitazone for Chronic myeloid leukemia (chronic phase)

Inclusion criteria

• {"criterion_text":"- CML in any phase, patient in MR4.5"}
• {"criterion_text":"- Loss of MMR following a first or subsequent TKI discontinuation trial."}
• {"criterion_text":"- Patient prior treated with imatinib, dasatinib, nilotinib, or bosutinib for more than 2 years from the last discontinuation"}
• {"criterion_text":"- Age >18 years."}
• {"criterion_text":"- Serum bilirubin <1.5 x upper limit of normal values"}
• {"criterion_text":"- AST (SGOT)/ALT (SGPT) <2.5x upper limit of normal values."}
• {"criterion_text":"- Females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period. Women of child bearing potential must have a negative urine pregnancy test at the time of enrollment. Acceptable methods of birth control include oral contraceptive, intrauterine device, transdermal/implanted or injected contraceptives and abstinence."}
• {"criterion_text":"- Males must agree to abstain from sexual activity or agree to utilize a medically-approved contraception method during and for 3 months after the treatment period."}
• {"criterion_text":"- Signed informed consent"}
• {"criterion_text":"- Be able and willing to comply with study visits and procedures."}

Exclusion criteria

• {"criterion_text":"- Participation in another clinical trial with any investigative drug within 30 days prior to study enrolment."}
• {"criterion_text":"- Prior allogeneic hematopoietic stem cell transplantation."}
• {"criterion_text":"- Patient requiring anti-diabetic medications to manage hyperglycemia."}
• {"criterion_text":"- Cardiovascular disease: history of congestive heart failure, myocardial infarction within the 6 months of study entry, symptomatic cardiac arrhythmia requiring treatment."}
• {"criterion_text":"- Hepatic insufficiency"}
• {"criterion_text":"- History of bladder cancer."}
• {"criterion_text":"- Diagnosed hematuria."}
• {"criterion_text":"- Known osteoporosis with curative therapy (prophylactic therapy is not an exclusion criteria)"}
• {"criterion_text":"- Known history of macular edema."}
• {"criterion_text":"- Use of TZD within 28 days prior to enrollment."}
• {"criterion_text":"- Known history of ABL1-domain mutation associated with resistance to the discontinued TKI."}
• {"criterion_text":"- Known allergy to PIO."}
• {"criterion_text":"- Pregnant or breastfeeding."}
• {"criterion_text":"- Significant gastrointestinal condition that could potentially impair the absorption or disposition of the drug."}
• {"criterion_text":"- Uncontrolled peripheral edema (grade 2+ or more) of any etiology."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"AEs graded according to CTCAE v4.03 through scheduled assessments and subject-reported diary. Pharmacokinetics: evaluate PK parameters of pioglitazone and TKIs (no further PK detail provided)."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Maintenance of MMR assessed by blood qRT-PCR for BCR-ABL1: monthly for first 6 months, every 3 months for the following 6 months, and every 6 months in the second year (then per center practice). Primary efficacy proportion is proportion of subjects maintaining MMR over 12 months after discontinuation."}

France

Latest Decision Or Authorization Date

10-10-2024

Number Of Sites

3

Number Of Participants

24

Primary sponsor

Full Name

Centre Hospitalier De Versailles

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France