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Completed

NCT Number: NCT04883125

Value of Using Pioglitazone in Chronic Myeloid Leukemia Treatment

Assessment of patients response and expression levels of CITED2 and HIF2a genes on adding pioglitazone to imatinib therapy.

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Key information

Conditions

Chronic Myelogenous Leukemia, BCR-ABL Positive Bone Marrow Diseases CML, Chronic Phase Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine

Al Mansurah, Dakahlia Governorate, 35511, Egypt

About this study

Eligible denovo CML patients will be treated by combination drug therapy of imatinib 400 mg plus pioglitazone (15 - 30mg).They will be on follow up for their complete blood count (CBC), chemistry profile and random blood sugar every 2 weeks. After 3, 6 and 12 months of treatment the patients response will be evaluated and compared with the obtained responses of a historical control group. Assessment of the hypoxia induced factor 2 alpha (HIF2a) gene and CBP/p300-interacting transactivator with glutamic acid (E) and aspartic acid (D)-rich tail 2 (CITED2) gene expression levels before and after 6 months of treatment will be additionally evaluated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • CML cases (BCR-ABL1 positive)

Exclusion criteria

  • Accelerated or blastic crisis
  • Atypical CML (BCR-ABL1 negative)
  • Chronic myelomonocytic leukemia (CMML)
  • Pregnant or breastfeeding females.
  • Patients with severe organ dysfunction

Treatment and study plan

Pioglitazone 15mg

Drug

pioglitazone (7.5-30 mg) once daily plus imatinib 400 mg 6 months

Other names: Imatinib 400mg

Primary outcomes

  1. Rate of major molecular response(MMR) at 12 months

    Time frame: 1 year

    Percentage of patients obtaining MMR at 12 months

  2. Impact of treatment on the expression levels of stemness genes

    Time frame: 6 months

    Follow up the expression of CITED2 and HIF2a genes pattern

Secondary outcomes

  1. Impact of treatment on the rate of transformation

    Time frame: 1 years

    Progression into accelerated or blastic phases

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Potential Utility of Peroxisome Proliferator-activated Receptor Gamma Agonists in the Eradication of Chronic Myeloid Leukemia Stem Cells: Myth or Truth?

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 12, 2021
Registry last updated
May 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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