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

Primary Purpose

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pioglitazone
imatinib mesylate
Sponsored by
Meng Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Myelogenous, Chronic, BCR-ABL Positive focused on measuring Pioglitazone, Chronic Myeloid Leukemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    pioglitazone

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    the rate of complete molecular response after the treatment of pioglitazone in combination with imatinib mesylate

    Secondary Outcome Measures

    the time for patients to complete molecular response from the beginning of adding pioglitazone
    the incidence rate of severe side effect or complication

    Full Information

    First Posted
    January 27, 2016
    Last Updated
    February 16, 2016
    Sponsor
    Meng Li
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02687425
    Brief Title
    Safety and Efficiency Study of Pioglitazone in Combination With Imatinib Mesylate to Treat Chronic Myelogenous Leukemia
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2016 (undefined)
    Primary Completion Date
    November 2016 (Anticipated)
    Study Completion Date
    June 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Meng Li

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Leukemia, Myelogenous, Chronic, BCR-ABL Positive
    Keywords
    Pioglitazone, Chronic Myeloid Leukemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    pioglitazone
    Arm Type
    Experimental
    Arm Description
    The patients under the long-term treatment of imatinib mesylate acquire pioglitazone additionally.
    Intervention Type
    Drug
    Intervention Name(s)
    Pioglitazone
    Other Intervention Name(s)
    Actos
    Intervention Description
    15mg/day,po
    Intervention Type
    Drug
    Intervention Name(s)
    imatinib mesylate
    Other Intervention Name(s)
    tyrosine kinase inhibitors
    Intervention Description
    400mg/day,po
    Primary Outcome Measure Information:
    Title
    the rate of complete molecular response after the treatment of pioglitazone in combination with imatinib mesylate
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    the time for patients to complete molecular response from the beginning of adding pioglitazone
    Time Frame
    one year
    Title
    the incidence rate of severe side effect or complication
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Li Meng
    Phone
    13396070793
    Email
    mengli19@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Li Meng
    Organizational Affiliation
    department of hematology, Wuhan Tongji Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    26331539
    Citation
    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.
    Results Reference
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    Safety and Efficiency Study of Pioglitazone in Combination With Imatinib Mesylate to Treat Chronic Myelogenous Leukemia

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