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

NCT ID: NCT02687425

Last Updated: 2016-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-06-30

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.

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

pioglitazone

The patients under the long-term treatment of imatinib mesylate acquire pioglitazone additionally.

Group Type: EXPERIMENTAL

Pioglitazone

Intervention Type: DRUG

15mg/day,po

imatinib mesylate

Intervention Type: DRUG

400mg/day,po

Interventions

Pioglitazone

15mg/day,po

Intervention Type: DRUG

imatinib mesylate

400mg/day,po

Intervention Type: DRUG

Other Intervention Names

Actos; tyrosine kinase inhibitors

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meng Li

OTHER

Sponsor Role: lead

Responsible Party

Meng Li

professor, department of hematology, Wuhan Tongji Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Li Meng

Role: STUDY_CHAIR

department of hematology, Wuhan Tongji Hospital

Central Contacts

Li Meng

Role: CONTACT

mengli19@hotmail.com

13396070793

References

Prost S, Relouzat F, Spentchian M, Ouzegdouh Y, Saliba J, Massonnet G, Beressi JP, Verhoeyen E, Raggueneau V, Maneglier B, Castaigne S, Chomienne C, Chretien S, Rousselot P, Leboulch P. Erosion of the chronic myeloid leukaemia stem cell pool by PPARgamma agonists. Nature. 2015 Sep 17;525(7569):380-3. doi: 10.1038/nature15248. Epub 2015 Sep 2.

Reference Type: BACKGROUND

PMID: 26331539 (View on PubMed)

Other Identifiers

CML-201602

Identifier Type: -

Identifier Source: org_study_id