Value of Using Pioglitazone in Chronic Myeloid Leukemia Treatment

Phase 2

Completed

• Conditions: Chronic Myelogenous Leukemia, BCR-ABL Positive; CML, Chronic Phase
• Interventions: Drug: Pioglitazone 15mg

• Registration Number: NCT04883125
• Lead Sponsor: Mansoura University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2021-04-15
• Study Completion: 2021-04-15
• Status Verified: 2021-05
• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-11
• Last Update Submitted: 2021-05-11
• Study First Posted: 2021-05-12
• Last Update Posted: 2021-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• CML cases (BCR-ABL1 positive)

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional no	Pioglitazone 15mg	Patients treated with both drugs ( imatinib and pioglitazone)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Impact of treatment on the rate of transformation	1 years	Progression into accelerated or blastic phases

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Mansoura, Dakahlia, Egypt