Could a diabetes drug help leukemia patients stay off cancer pills?

NCT ID NCT02889003

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 26 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2016

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

chronic myelogenous leukemia, BCR-ABL1 positive Leukemia, Myelogenous, Chronic, BCR-ABL Positive

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.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • CHU Lyon

    RECRUITING

    Lyon, France

  • CHU de Nantes

    WITHDRAWN

    Nantes, 44093, France

  • CHU de Rennes

    WITHDRAWN

    Rennes, 35033, France

  • Centre Hospitalier de Versailles

    RECRUITING

    Le Chesnay, 78150, France

  • Hôpital Bicêtre

    WITHDRAWN

    Le Kremlin-Bicêtre, 94275, France

  • IUCT

    RECRUITING

    Toulouse, France

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