Safety and Efficiency Study of Pioglitazone in Combination With Imatinib Mesylate to Treat Chronic Myelogenous Leukemia

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and efficiency of adding pioglitazone to chronic phase chronic myelogenous leukemia patients having received imatinib mesylate who have acquired a stable molecular response but not complete molecular response.

Detailed Description
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Although tyrosine-kinase inhibitors have profoundly converted the outcomes of chronic myelogenous leukemia patients ,the most of who could have a complete cytogenetic response, a large majority of patients could not come to a complete molecular response that is undetectable in breakpoint cluster region-Abelson chimeric oncogene transcripts. According to some previous researches, pioglitazone may target leukemia stem cells and induce them into cell cycle making them exit from quiescent undivided states. Subsequently, pioglitazone may gradually erode leukemia stem cells leading to undetectable minimal residual disease. Thus the investigators expect to assess the safety and efficiency of pioglitazone in combination with imatinib mesylate in clinical trials. Maybe the combination therapy induce more patients in a detectable molecular response into a deeper molecular response. Furthermore, pioglitazone may be extensively adapted into the treatment of chronic phase chronic myelogenous leukemia patients as a common protocol.

Official Title
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Phase 2 Study to Assess the Safety and Efficiency of Pioglitazone in Combination With Imatinib Mesylate to Treat Chronic Phase Chronic Myelogenous Leukemia Patients

Conditions
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Intervention / Treatment
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* Drug: Pioglitazone
* Drug: imatinib mesylate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent. Treatment with imatinib mesylate for more than 2 years. Patients with chronic phase chronic myelogenous leukemia having a complete cytogenetic response and a stable molecular response without complete molecular response. Normal important organs such as kidney, liver and heart. Exclusion Criteria: Severe important organs disfunction such as liver and kidney. Cardiovascular disease. Osteoporosis in therapy. Severe fluid retention.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pioglitazone<br>The patients under the long-term treatment of imatinib mesylate acquire pioglitazone additionally. | Drug: Pioglitazone<br>* 15mg/day,po<br>* Other names: Actos;Drug: imatinib mesylate<br>* 400mg/day,po<br>* Other names: tyrosine kinase inhibitors;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of complete molecular response after the treatment of pioglitazone in combination with imatinib mesylate |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time for patients to complete molecular response from the beginning of adding pioglitazone |  | one year | 
| the incidence rate of severe side effect or complication |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pioglitazone, Chronic Myeloid Leukemia