Second STOP After Pioglitazone Priming in CML Patients

Ki vehet részt

• CML in any phase. patient in MR4
• Loss of MMR following a first or subsequent TKI discontinuation trial
• Patient prior treated with imatinib, dasatinib, nilotinib, or bosutinib
• Age >18 years
• Serum bilirubin <1.5 x upper limit of normal values
• AST (SGOT)/ALT (SGPT) <2.5x upper limit of normal values
• 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
• 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
• Signed informed consent
• Be able and willing to comply with study visits and procedures

Ki nem vehet részt

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