Could a diabetes drug help leukemia patients stay off cancer pills?
NCT ID NCT02889003
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This study tests whether adding pioglitazone (a diabetes drug) to standard tyrosine kinase inhibitors (TKIs) can help people with chronic myeloid leukemia (CML) who lost remission after stopping TKI therapy. Participants take the combination for at least six months, then stop all treatment to see if they can maintain remission for a year. The goal is to find a way for more patients to safely discontinue long-term TKI use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pioglitazone plus a tyrosine kinase inhibitor (TKI)
- What this could lead to
- If successful, this combination may allow some CML patients to safely stop TKI therapy again and remain in remission without continuous medication.
- What could go wrong
- This is a small, early-phase study (26 participants). The combination may cause side effects or fail to prevent relapse, and results may not apply to all CML patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2016
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU Lyon
RECRUITINGLyon, France
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CHU de Nantes
WITHDRAWNNantes, 44093, France
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CHU de Rennes
WITHDRAWNRennes, 35033, France
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Centre Hospitalier de Versailles
RECRUITINGLe Chesnay, 78150, France
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Hôpital Bicêtre
WITHDRAWNLe Kremlin-Bicêtre, 94275, France
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IUCT
RECRUITINGToulouse, France
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