Leukemia, Myeloid, Chronic-PhasePhase 2ACTIMNCT02888964
Pioglityazone and Imatinib for CML Patients
A Phase 2 study testing Add-on therapy in people with Leukemia, Myeloid, Chronic-Phase, run by Versailles Hospital at 9 sites in France.
Trial summary
This project is a Phase II clinical trial that aims at evaluating efficacy and tolerance of the combination of pioglitazone (Actos®) and imatinib mesylate (STI571, CGP57148, Gleevec®) in patients with Chronic Myelogenous Leukemia (CML) in stable major molecular response (i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid, Chronic-Phase
- What is being tested?
- Add-on therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 9 sitesFrance
- Study dates
- Dec 2009to Feb 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18y or more
- Signed informed consent
- Patient with Philadelphia chromosome positive chronic phase CML and M BCR-ABL transcript positivity
- Treatment with imatinib for more than 2 years
- No dose modification of imatinib within the last 3 months
- Complete cytogenetic response on the last cytogenetic analysis within the last 12 months
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- Major molecular remission without complete molecular remission
- ECOG grade 0 to 2
- SGOT et SGPT ≤ 2.5 N
- Bilirubin in serum ≤ 1.5 N
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception
Who cannot join
- Participation in another clinical trial with any investigative drug within 30 days prior to study enrollment
- Prior history of hematopoietic stem cell transplantation (autologous or allogenic)
- Patient requiring anti-diabetic medication
- 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
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- Symptomatic cardiac arrhythmia requiring treatment
- Grade III or IV fluid retention
- Known osteoporosis with therapy
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CHR Annecy
Annecy
Institut Bergonié
Bordeaux
CH Versailles
Le Chesnay
CHU Lille
Lille
IPC
Marseille
CHU archet 1
Nice
St Louis
Paris
CHU Poitiers
Poitiers
CHU Purpan
Toulouse
About this study
Official title: A Study to Assess Efficacy and Safety of Pioglitazone as Add-On Therapy to Imatinib Mesylate in CP-CML Patients in Major Molecular Response
This project is a Phase II clinical trial that aims at evaluating efficacy and tolerance of the combination of pioglitazone (Actos®) and imatinib mesylate (STI571, CGP57148, Gleevec®) in patients with Chronic Myelogenous Leukemia (CML) in stable major molecular response (i.e. a BCRABL/ABL ratio assessed by RTQ-PCR equal to or lower than 0.1% according to the European Leukemia Net recommendations) after at least 2 years of therapy with imatinib.
Imatinib mesylate (Gleevec®) is the gold standard for the treatment of CML in chronic phase (O Brian et al. 2003, Druker et al. 2006). Despite a high efficacy of the drug, CML is not eradicated by imatinib alone in almost any of the patients.
Read more
Treatment discontinuation in patients treated by imatinib and in complete molecular remission for more than 2 years yield molecular relapses within 6 months in half of the patients,indicating the persistence of CML progenitor cells. STAT5 expression is required for CML stem cell engraftment and expansion in mouse models. STAT5 is the target of the dysregulated activity of BCR-ABL in CML.
Recently, Stephane Prost et al. demonstrated that PPAR-γ is a negative regulator of STAT5A and STAT5B gene expression. Data obtained suggest that PPAR-γ agonists may have potential therapeutic value in reversing myeloproliferative disorders. On the basis of our preclinical studies, we went ahead and administered pioglitazone to one patient who suffered from both diabetes type II and CML with residual disease after continuous treatment with Gleevec. The amount of BCR-ABL transcript detected by QPCR decreased dramatically during the first 3 months of combined (Gleevec + ACTOS) therapy to become undetectable thereafter until 9 months post-treatment, the latest time point assessed. This striking anecdotal result now forms the rationale for filing this formal Phase II clinical trial application.
- Conditions
- Leukemia, Myeloid, Chronic-Phase
- Being tested
- Add-on therapy
- Medical subject headings
- Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Add-on therapyDrug
Pioglitazone therapy
| Study group | Role | What they receive |
|---|---|---|
| ACTOS treatment | Experimental | Imatinib mesylate at the same daily dose and pioglitazone as add-on therapy at 30 mg/d during 2 months and then 45 mg/d in the absence of serious adverse events Receives: Drug: Add-on therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of patients achieving a complete molecular response (Sensitivity 10-5 or Bcr Abl/Abl ratio < 0.001 %) 24 weeks after the initiation of pioglitazone, confirmed on by a second determination 2 months later.
Measured: 26 weeks
Secondary outcomes (5)
Adverse events
Measured: 5 years
Duration of the complete molecular response
Measured: 5 years
The rate of patients achieving a complete molecular response (Sensitivity 10-5 or Bcr-Abl/Abl ratio < 0.001 %)
Measured: 14 months
Survival
Measured: 5 years
Progression free survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startDec 2009
- Primary completionFeb 2012
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leukemia, Myeloid, Chronic-PhaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe ROUSSELOT, Versailles Hospital
- Investigators
- Rousselot Philippe, MD, Principal investigator, CH Versailles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888964
- Sponsor's protocol ID
- 09/37_ACTIM
- Acronym
- ACTIM
- Status last verified
- Jul 2026
- First submitted
- 19 Aug 2016
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Rousselot P, Prost S, Guilhot J, Roy L, Etienne G, Legros L, Charbonnier A, Coiteux V, Cony-Makhoul P, Huguet F, Cayssials E, Cayuela JM, Relouzat F, Delord M, Bruzzoni-Giovanelli H, Morisset L, Mahon FX, Guilhot F, Leboulch P; French CML Group. Pioglitazone together with imatinib in chronic myeloid leukemia: A proof of concept study. Cancer. 2017 May 15;123(10):1791-1799. doi: 10.1002/cncr.30490. Epub 2016 Dec 27.
PubMed 28026860
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess Efficacy and Safety of Pioglitazone as Add-On Therapy to Imatinib Mesylate in CP-CML Patients in Major Molecular Response
- ClinicalTrials.gov ID
- NCT02888964
- Acronym / sponsor ID
- ACTIM / 09/37_ACTIM
- Conditions
- Leukemia, Myeloid, Chronic-Phase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 5 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is a Phase II clinical trial that aims at evaluating efficacy and tolerance of the combination of pioglitazone (Actos®) and imatinib mesylate (STI571, CGP57148, Gleevec®) in patients with Chronic Myelogenous Leukemia (CML) in stable major molecular response (i.e. a BCRABL/ABL ratio assessed by RTQ-PCR equal to or lower than 0.1% according to the European Leukemia Net recommendations) after at least 2 years of therapy with imatinib.
Imatinib mesylate (Gleevec®) is the gold standard for the treatment of CML in chronic phase (O Brian et al. 2003, Druker et al. 2006). Despite a high efficacy of the drug, CML is not eradicated by imatinib alone in almost any of the patients.
Treatment discontinuation in patients treated by imatinib and in complete molecular remission for more than 2 years yield molecular relapses within 6 months in half of the patients,indicating the persistence of CML progenitor cells. STAT5 expression is required for CML stem cell engraftment and expansion in mouse models. STAT5 is the target of the dysregulated activity of BCR-ABL in CML.
Recently, Stephane Prost et al. demonstrated that PPAR-γ is a negative regulator of STAT5A and STAT5B gene expression. Data obtained suggest that PPAR-γ agonists may have potential therapeutic value in reversing myeloproliferative disorders. On the basis of our preclinical studies, we went ahead and administered pioglitazone to one patient who suffered from both diabetes type II and CML with residual disease after continuous treatment with Gleevec. The amount of BCR-ABL transcript detected by QPCR decreased dramatically during the first 3 months of combined (Gleevec + ACTOS) therapy to become undetectable thereafter until 9 months post-treatment, the latest time point assessed. This striking anecdotal result now forms the rationale for filing this formal Phase II clinical trial application.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACTOS treatment | Experimental | Drug: Add-on therapyImatinib mesylate at the same daily dose and pioglitazone as add-on therapy at 30 mg/d during 2 months and then 45 mg/d in the absence of serious adverse events |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient aged 18y or more
- Signed informed consent
- Patient with Philadelphia chromosome positive chronic phase CML and M BCR-ABL transcript positivity
- Treatment with imatinib for more than 2 years
- No dose modification of imatinib within the last 3 months
Key exclusion criteria (9 listed)
- Participation in another clinical trial with any investigative drug within 30 days prior to study enrollment
- Prior history of hematopoietic stem cell transplantation (autologous or allogenic)
- Patient requiring anti-diabetic medication
- Cardiovascular disease:
- Grade III or IV fluid retention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Add-on therapyPioglitazone therapy | Drug | ACTOS treatment |
Primary outcome
The rate of patients achieving a complete molecular response (Sensitivity 10-5 or Bcr Abl/Abl ratio < 0.001 %) 24 weeks after the initiation of pioglitazone, confirmed on by a second determination 2 months later.
Time frame: 26 weeks
5 secondary outcomes
Adverse events
Time frame: 5 years
Duration of the complete molecular response
Time frame: 5 years
The rate of patients achieving a complete molecular response (Sensitivity 10-5 or Bcr-Abl/Abl ratio < 0.001 %)
Time frame: 14 months
Survival
Time frame: 5 years
Progression free survival
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Results publication: PubMed 28026860Rousselot P, Prost S, Guilhot J, Roy L, Etienne G, Legros L, Charbonnier A, Coiteux V, Cony-Makhoul P, Huguet F, Cayssials E, Cayuela JM, Relouzat F, Delord M, Bruzzoni-Giovanelli H, Morisset L, Mahon FX, Guilhot F, Leboulch P; French CML Group. Pioglitazone together with imatinib in chronic myeloid leukemia: A proof of concept study. Cancer. 2017 May 15;123(10):1791-1799. doi: 10.1002/cncr.30490. Epub 2016 Dec 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rousselot Philippe, MD principal investigator
CH Versailles
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Add-on therapy in people with Leukemia, Myeloid, Chronic-Phase, run by Versailles Hospital at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of patients achieving a complete molecular response (Sensitivity 10-5 or Bcr Abl/Abl ratio < 0.001 %) 24 weeks after the initiation of pioglitazone, confirmed on by a second determination 2 months later. (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02888964, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.