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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2016

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.

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • the rate of complete molecular response after the treatment of pioglitazone in combination with imatinib mesylate
    • Time Frame: one year

Secondary Measures

  • the time for patients to complete molecular response from the beginning of adding pioglitazone
    • Time Frame: one year
  • the incidence rate of severe side effect or complication
    • Time Frame: one year

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Meng Li
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Meng Li, professor, department of hematology, Wuhan Tongji Hospital – Tongji Hospital
  • Overall Official(s)
    • Li Meng, Study Chair, department of hematology, Wuhan Tongji Hospital
  • Overall Contact(s)
    • Li Meng, 13396070793, mengli19@hotmail.com

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, Chr├ętien 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.

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