Value of Using Pioglitazone in Chronic Myeloid Leukemia Treatment

May 11, 2021 updated by: Basma Atef, Mansoura University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

90

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 Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35511
        • Faculty of medicine

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

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Interventional no
Patients treated with both drugs ( imatinib and pioglitazone)
Drug: Pioglitazone 15mg
pioglitazone (7.5-30 mg) once daily plus imatinib 400 mg 6 months
Other Names:
  • Imatinib 400mg
NO_INTERVENTION: Control
Historical control (treated with imatinib only)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of major molecular response(MMR) at 12 months
Time Frame: 1 year
Percentage of patients obtaining MMR at 12 months
1 year
Impact of treatment on the expression levels of stemness genes
Time Frame: 6 months
Follow up the expression of CITED2 and HIF2a genes pattern
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of treatment on the rate of transformation
Time Frame: 1 years
Progression into accelerated or blastic phases
1 years

Collaborators and Investigators

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

Sponsor

Mansoura University

Investigators

  • Study Director: Mohamed N. Mabed, Professor, Oncology center Mansoura University

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 (ACTUAL)

January 1, 2018

Primary Completion (ACTUAL)

April 15, 2021

Study Completion (ACTUAL)

April 15, 2021

Study Registration Dates

First Submitted

May 11, 2021

First Submitted That Met QC Criteria

May 11, 2021

First Posted (ACTUAL)

May 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 12, 2021

Last Update Submitted That Met QC Criteria

May 11, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD/17.12.30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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