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

Leukemia, Myelogenous, Chronic, BCR-ABL Positive Clinical Trial

— SESPI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02687425
• Other study ID #: CML-201602
• Status: Not yet recruiting
• Phase: Phase 2
• First received: January 27, 2016
• Last updated: February 16, 2016
• Start date: February 2016
• Est. completion date: June 2017

Study information

• Verified date: February 2016
• Source: Tongji Hospital
• Contact: Li Meng
• Phone: 13396070793
• Email: mengli19[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Hubei Province
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase

Intervention

Drug:
• Pioglitazone
15mg/day,po
• imatinib mesylate
400mg/day,po

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meng Li

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of complete molecular response after the treatment of pioglitazone in combination with imatinib mesylate		one year	No
Secondary	the time for patients to complete molecular response from the beginning of adding pioglitazone		one year	No
Secondary	the incidence rate of severe side effect or complication		one year	Yes