Value of Using Pioglitazone in Chronic Myeloid Leukemia Treatment

CML, Chronic Phase Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04883125
• Other study ID #: MD/17.12.30
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2018
• Est. completion date: April 15, 2021

Study information

• Verified date: May 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 15, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• CML, Chronic Phase
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase

Intervention

Drug:
• Pioglitazone 15mg
pioglitazone (7.5-30 mg) once daily plus imatinib 400 mg 6 months

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of major molecular response(MMR) at 12 months	Percentage of patients obtaining MMR at 12 months	1 year
Primary	Impact of treatment on the expression levels of stemness genes	Follow up the expression of CITED2 and HIF2a genes pattern	6 months
Secondary	Impact of treatment on the rate of transformation	Progression into accelerated or blastic phases	1 years