Diabetes drug could help eradicate hidden leukemia cells
NCT ID NCT02888964
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether adding pioglitazone (a diabetes drug) to the standard leukemia medication imatinib can eliminate remaining cancer cells in people with chronic-phase chronic myeloid leukemia (CML). Participants must have been on imatinib for at least two years and have a stable low level of leukemia cells. The goal is to see if the combination can achieve a complete molecular response, meaning no detectable leukemia cells, within 24 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pioglitazone (Actos) added to imatinib mesylate (Gleevec)
- What this could lead to
- If successful, this combination could help more CML patients achieve undetectable levels of leukemia cells, potentially allowing some to stop treatment without relapse.
- What could go wrong
- This is a small early-phase trial with only 27 participants, so results may not apply broadly. Pioglitazone has known side effects including fluid retention and risk of bladder cancer.
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
-
27 people
The number who actually took part.
- Start date
-
Dec 2009
- Finished
-
Feb 2016
- 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
-
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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patient aged 18y or more 2. Signed informed consent 3. Patient with Philadelphia chromosome positive chronic phase CML and M BCR-ABL transcript positivity 4. Treatment with imatinib for more than 2 years 5. No dose modification of imatinib within the last 3 months 6. Complete cytogenetic response on the last cytogenetic analysis within the last 12 months 7. Major molecular remission without complete molecular remission 8. ECOG grade 0 to 2 9. SGOT et SGPT ≤ 2.5 N 10. Bilirubin in serum ≤ 1.5 N 11. Women of childbearing potential (WOCBP) must be using an adequate method of contraception Exclusion Criteria: 1. Participation in another clinical trial with any investigative drug within 30 days prior to study enrollment 2. Prior history of hematopoietic stem cell transplantation (autologous or allogenic) 3. Patient requiring anti-diabetic medication 4. Cardiovascular disease: * Stage I to IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA) classification system for heart failure * Myocardial infarction within the previous 6 months * Symptomatic cardiac arrhythmia requiring treatment 5. Grade III or IV fluid retention 6. Known osteoporosis with therapy
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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.
Contacts and locations
Locations
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CH Versailles
Le Chesnay, France
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CHR Annecy
Annecy, France
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CHU Lille
Lille, France
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CHU Poitiers
Poitiers, France
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CHU Purpan
Toulouse, France
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CHU archet 1
Nice, France
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IPC
Marseille, France
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Institut Bergonié
Bordeaux, France
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St Louis
Paris, France
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