Clinical trial NCT02687425: Safety and Efficiency Study of Pioglitazone in Combination With Imatinib Mesylate to Treat Chronic Myelogenous Leukemia
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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Keywords: Pioglitazone
Chronic Myeloid Leukemia
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2016-02-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the rate of complete molecular response after the treatment of pioglitazone in combination with imatinib mesylate
timeFrame: one year
Secondary outcomes:
measure: the time for patients to complete molecular response from the beginning of adding pioglitazone
timeFrame: one year
measure: the incidence rate of severe side effect or complication
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: department of hematology, Wuhan Tongji Hospital
name: Li Meng
role: STUDY_CHAIR
References:
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.