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

February 16, 2016 updated by: Meng Li

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pioglitazone
The patients under the long-term treatment of imatinib mesylate acquire pioglitazone additionally.
Drug: Pioglitazone
15mg/day,po
Other Names:
  • Actos
Drug: imatinib mesylate
400mg/day,po
Other Names:
  • tyrosine kinase inhibitors

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meng Li

Investigators

  • Study Chair: Li Meng, department of hematology, Wuhan Tongji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

January 27, 2016

First Submitted That Met QC Criteria

February 16, 2016

First Posted (Estimate)

February 22, 2016

Study Record Updates

Last Update Posted (Estimate)

February 22, 2016

Last Update Submitted That Met QC Criteria

February 16, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CML-201602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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