Value of Using Pioglitazone in Chronic Myeloid Leukemia Treatment

NCT04883125 | Completed Phase 2 DMC

• 1 other identifier: MD/17.12.30
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Rate of major molecular response(MMR) at 12 months

  Percentage of patients obtaining MMR at 12 months

  1 year

• Impact of treatment on the expression levels of stemness genes

  Follow up the expression of CITED2 and HIF2a genes pattern

  6 months

Secondary Outcomes (1)

• Impact of treatment on the rate of transformation

  1 years

Study Arms (2)

Interventional no

ACTIVE COMPARATOR

Patients treated with both drugs ( imatinib and pioglitazone)

Drug: Pioglitazone 15mg

Control

NO INTERVENTION

Historical control (treated with imatinib only)

Interventions

Pioglitazone 15mg DRUG

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

Also known as: Imatinib 400mg

Interventional no

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• CML cases (BCR-ABL1 positive)

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Medicine

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase

Interventions

Pioglitazone; Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Pyrimidines

Study Officials

• Mohamed N. Mabed, Professor

  Oncology Center Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Hematology (Internal medicine department)

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 12, 2021
• Study Start: January 1, 2018
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: May 12, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)