Second STOP After Pioglitazone Priming in CML Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, prospective phase II trial evaluating safety and how the drug combo behaves in the body when pioglitazone is added to a TKI in CML patients who lost MMR after stopping a TKI. Participants have received prior TKIs (imatinib, dasatinib, nilotinib, or bosutinib) and are over 18 years old. The study follows patients for at least 6 months of combination therapy and then up to 12 months after a second TKI discontinuation to see if MMR is preserved. Primary aims focus on safety and pharmacokinetics, with a secondary goal of seeing whether MMR is maintained without relapse over the 12-month period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. CML in any phase. patient in MR4
2. Loss of MMR following a first or subsequent TKI discontinuation trial.
3. Patient prior treated with imatinib, dasatinib, nilotinib, or bosutinib
4. Age \>18 years.
5. Serum bilirubin \<1.5 x upper limit of normal values.
6. AST (SGOT)/ALT (SGPT) \<2.5x upper limit of normal values.
7. 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.
8. 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.
9. Signed informed consent.
10. Be able and willing to comply with study visits and procedures

Exclusion Criteria:

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

Where it's running

• Centre Hospitalier de Versailles
  Le Chesnay, France Recruiting
• CHU Lyon
  Lyon, France Recruiting
• Iuct
  Toulouse, France Recruiting
• Hôpital Bicêtre
  Le Kremlin-Bicêtre, France Withdrawn
• CHU de Nantes
  Nantes, France Withdrawn
• CHU de Rennes
  Rennes, France Withdrawn

Study contacts

• Study coordinator: Sandrine Roux, MC
• Email: sroux@ght78sud.fr
• Phone: +33139239777

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.