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

Phase 2

• Conditions: Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Interventions: Drug: Pioglitazone; Drug: imatinib mesylate

• Registration Number: NCT02687425
• Lead Sponsor: Meng Li

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-01-27
• Status Verified: 2016-02
• Study Start: 2016-02
• Study First Submitted QC: 2016-02-16
• Last Update Submitted: 2016-02-16
• Study First Posted: 2016-02-22
• Last Update Posted: 2016-02-22
• Primary Completion: 2016-11
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Signed informed consent.
2. Treatment with imatinib mesylate for more than 2 years.
3. Patients with chronic phase chronic myelogenous leukemia having a complete cytogenetic response and a stable molecular response without complete molecular response.
4. Normal important organs such as kidney, liver and heart.

Exclusion Criteria

1. Severe important organs disfunction such as liver and kidney.
2. Cardiovascular disease.
3. Osteoporosis in therapy.
4. Severe fluid retention.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pioglitazone	imatinib mesylate	The patients under the long-term treatment of imatinib mesylate acquire pioglitazone additionally.
pioglitazone	Pioglitazone	The patients under the long-term treatment of imatinib mesylate acquire pioglitazone additionally.

Primary Outcome Measures

Name	Time	Method
the rate of complete molecular response after the treatment of pioglitazone in combination with imatinib mesylate	one year

Secondary Outcome Measures

Name	Time	Method
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