Back to resultsValue of Using Pioglitazone in Chronic Myeloid Leukemia Treatment
Primary Purpose
Chronic Myelogenous Leukemia, BCR-ABL Positive, CML, Chronic Phase
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Pioglitazone 15mg
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Myelogenous Leukemia, BCR-ABL Positive
Eligibility Criteria
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
Sites / Locations
- Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Interventional no
Control
Arm Description
Patients treated with both drugs ( imatinib and pioglitazone)
Historical control (treated with imatinib only)
Outcomes
Primary Outcome Measures
Rate of major molecular response(MMR) at 12 months
Percentage of patients obtaining MMR at 12 months
Impact of treatment on the expression levels of stemness genes
Follow up the expression of CITED2 and HIF2a genes pattern
Secondary Outcome Measures
Impact of treatment on the rate of transformation
Progression into accelerated or blastic phases
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04883125
Brief Title
Value of Using Pioglitazone in Chronic Myeloid Leukemia Treatment
Official Title
Potential Utility of Peroxisome Proliferator-activated Receptor Gamma Agonists in the Eradication of Chronic Myeloid Leukemia Stem Cells: Myth or Truth?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
April 15, 2021 (Actual)
Study Completion Date
April 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myelogenous Leukemia, BCR-ABL Positive, CML, Chronic Phase
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional no
Arm Type
Active Comparator
Arm Description
Patients treated with both drugs ( imatinib and pioglitazone)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Historical control (treated with imatinib only)
Intervention Type
Drug
Intervention Name(s)
Pioglitazone 15mg
Other Intervention Name(s)
Imatinib 400mg
Intervention Description
pioglitazone (7.5-30 mg) once daily plus imatinib 400 mg 6 months
Primary Outcome Measure Information:
Title
Rate of major molecular response(MMR) at 12 months
Description
Percentage of patients obtaining MMR at 12 months
Time Frame
1 year
Title
Impact of treatment on the expression levels of stemness genes
Description
Follow up the expression of CITED2 and HIF2a genes pattern
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Impact of treatment on the rate of transformation
Description
Progression into accelerated or blastic phases
Time Frame
1 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed N. Mabed, Professor
Organizational Affiliation
Oncology Center Mansoura University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Value of Using Pioglitazone in Chronic Myeloid Leukemia Treatment
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