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

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ClinicalTrials.gov Identifier: NCT02687425
Recruitment Status : Unknown
Verified February 2016 by Meng Li, Tongji Hospital.
Recruitment status was:  Not yet recruiting
First Posted : February 22, 2016
Last Update Posted : February 22, 2016
Sponsor:
Information provided by (Responsible Party):
Meng Li, Tongji Hospital

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.

Condition or disease Intervention/treatment Phase
Leukemia, Myelogenous, Chronic, BCR-ABL Positive Drug: Pioglitazone Drug: imatinib mesylate Phase 2

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2016
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : June 2017


Arm Intervention/treatment
Experimental: pioglitazone
The patients under the long-term treatment of imatinib mesylate acquire pioglitazone additionally.
Drug: Pioglitazone
15mg/day,po
Other Name: Actos

Drug: imatinib mesylate
400mg/day,po
Other Name: tyrosine kinase inhibitors




Primary Outcome Measures :
  1. the rate of complete molecular response after the treatment of pioglitazone in combination with imatinib mesylate [ Time Frame: one year ]

Secondary Outcome Measures :
  1. the time for patients to complete molecular response from the beginning of adding pioglitazone [ Time Frame: one year ]
  2. the incidence rate of severe side effect or complication [ Time Frame: one year ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687425


Contacts
Contact: Li Meng 13396070793 mengli19@hotmail.com

Sponsors and Collaborators
Meng Li
Investigators
Study Chair: Li Meng department of hematology, Wuhan Tongji Hospital

Publications:
Responsible Party: Meng Li, professor, department of hematology, Wuhan Tongji Hospital, Tongji Hospital
ClinicalTrials.gov Identifier: NCT02687425     History of Changes
Other Study ID Numbers: CML-201602
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Meng Li, Tongji Hospital:
Pioglitazone
Chronic Myeloid Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Pioglitazone
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs