Value of Using Pioglitazone in Chronic Myeloid Leukemia Treatment

Mansoura University

Status and phase: Completed; Phase 2

Conditions: Chronic Myelogenous Leukemia, BCR-ABL Positive; CML, Chronic Phase

Treatments: Drug: Pioglitazone 15mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04883125

MD/17.12.30

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Interventional no

Active Comparator group

Description:

Patients treated with both drugs ( imatinib and pioglitazone)

Treatment:

Drug: Pioglitazone 15mg

Control

No Intervention group

Description:

Historical control (treated with imatinib only)