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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02687425
Acronym
SESPI
Enrollment
20
Registered
2016-02-22
Start date
2016-02-29
Completion date
2017-06-30
Last updated
2016-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Keywords

Pioglitazone, Chronic Myeloid Leukemia

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.

Interventions

DRUGPioglitazone

15mg/day,po

DRUGimatinib mesylate

400mg/day,po

Sponsors

Meng Li
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
the rate of complete molecular response after the treatment of pioglitazone in combination with imatinib mesylateone year

Secondary

MeasureTime frame
the time for patients to complete molecular response from the beginning of adding pioglitazoneone year
the incidence rate of severe side effect or complicationone year

Contacts

Primary ContactLi Meng
mengli19@hotmail.com13396070793

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026