Value of Using Pioglitazone in Chronic Myeloid Leukemia Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-04-15

Brief Summary

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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interventional no

Patients treated with both drugs ( imatinib and pioglitazone)

Group Type ACTIVE_COMPARATOR

Pioglitazone 15mg

Intervention Type DRUG

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

Control

Historical control (treated with imatinib only)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pioglitazone 15mg

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

Intervention Type DRUG

Other Intervention Names

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Imatinib 400mg

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No