Second STOP After Pioglitazone Priming in CML Patients

Combination Study of Pioglitazone and Tyrosine Kinase Inhibitors (TKIs) in Chronic Myeloid Leukemia Patients After Failure of a First TKIs Discontinuation Attempt in Order to Prepare a New Stop

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02889003

Acronym

PIO2STOP

Enrollment

Registered

2016-09-05

Start date

2016-12-01

Completion date

2028-12-01

Last updated

2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myeloid Leukemia (CML)

Brief summary

Single-center study, prospective, phase II trial. The study objectives are : * To assess safety and pharmacokinetics of the combination of PIO and TKI in CML subjects who experience a loss of MMR following a first TKI discontinuation. * To assess survival without loss of MMR over a 12 months period following a second TKI discontinuation in subjects who achieve or maintain \< MR4.5 with the combination PIO and TKI administered for at least 6 months.

Interventions

DRUGPioglitazone + TKI

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Up to 24 months after inclusion
Treatment free survival after pioglitazone and tyrosine kinase inhibitor discontinuation.	Up to 24 months after inclusion

Countries

France

Contacts

CONTACTSandrine Roux, MC

sroux@ght78sud.fr+33139239777

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026