Chronic Myelogenous Leukemia, BCR-ABL PositivePhase 2NCT04883125
Value of Using Pioglitazone in Chronic Myeloid Leukemia Treatment
A Phase 2 study testing Pioglitazone 15mg in people with Chronic Myelogenous Leukemia, BCR-ABL Positive and CML, Chronic Phase, run by Mansoura University at 1 site in Egypt.
Trial summary
Assessment of patients response and expression levels of CITED2 and HIF2a genes on adding pioglitazone to imatinib therapy. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Chronic Myelogenous Leukemia, BCR-ABL Positive, CML, Chronic Phase
- What is being tested?
- Pioglitazone 15mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 15 Apr 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- CML cases (BCR-ABL1 positive)
Who cannot join
- Accelerated or blastic crisis
- Atypical CML (BCR-ABL1 negative)
- Chronic myelomonocytic leukemia (CMML)
- Pregnant or breastfeeding females.
- Patients with severe organ dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Potential Utility of Peroxisome Proliferator-activated Receptor Gamma Agonists in the Eradication of Chronic Myeloid Leukemia Stem Cells: Myth or Truth?
Assessment of patients response and expression levels of CITED2 and HIF2a genes on adding pioglitazone to imatinib therapy.
Read the 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.
- Being tested
- Pioglitazone 15mg
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pioglitazone 15mgDrug
Also called Imatinib 400mg
pioglitazone (7.5-30 mg) once daily plus imatinib 400 mg 6 months
| Study group | Role | What they receive |
|---|---|---|
| Interventional no | Active comparator | Patients treated with both drugs ( imatinib and pioglitazone) Receives: Drug: Pioglitazone 15mg |
| Control | No intervention | Historical control (treated with imatinib only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of major molecular response(MMR) at 12 months
Percentage of patients obtaining MMR at 12 months
Measured: 1 year
Impact of treatment on the expression levels of stemness genes
Follow up the expression of CITED2 and HIF2a genes pattern
Measured: 6 months
Secondary outcomes (1)
Impact of treatment on the rate of transformation
Progression into accelerated or blastic phases
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start1 Jan 2018
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Myelogenous Leukemia, BCR-ABL PositiveStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Atef, Mansoura University
- Investigators
- Mohamed N. Mabed, Professor, Study director, Oncology Center Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883125
- Sponsor's protocol ID
- MD/17.12.30
- Status last verified
- May 2021
- First submitted
- 11 May 2021
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Atef B, El-Ashwah S, Saleh LM, Gawish H, Mabed M. Potential utility of PPARgamma agonists in targeting chronic myeloid leukemia stem cells. Ann Hematol. 2026 Feb 25;105(4):136. doi: 10.1007/s00277-026-06795-7.
PubMed 41735647
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Utility of Peroxisome Proliferator-activated Receptor Gamma Agonists in the Eradication of Chronic Myeloid Leukemia Stem Cells: Myth or Truth?
- ClinicalTrials.gov ID
- NCT04883125
- Acronym / sponsor ID
- MD/17.12.30
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional no | Active comparator | Drug: Pioglitazone 15mgPatients treated with both drugs ( imatinib and pioglitazone) |
| Control | No intervention | –Historical control (treated with imatinib only) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- CML cases (BCR-ABL1 positive)
Key exclusion criteria (5 listed)
- Accelerated or blastic crisis
- Atypical CML (BCR-ABL1 negative)
- Chronic myelomonocytic leukemia (CMML)
- Pregnant or breastfeeding females.
- Patients with severe organ dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pioglitazone 15mgAlso: Imatinib 400mgpioglitazone (7.5-30 mg) once daily plus imatinib 400 mg 6 months | Drug | Interventional no |
Primary outcome
Rate of major molecular response(MMR) at 12 months
Time frame: 1 year
Percentage of patients obtaining MMR at 12 months
Impact of treatment on the expression levels of stemness genes
Time frame: 6 months
Follow up the expression of CITED2 and HIF2a genes pattern
1 secondary outcome
Impact of treatment on the rate of transformation
Time frame: 1 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- Derived from this study: PubMed 41735647Atef B, El-Ashwah S, Saleh LM, Gawish H, Mabed M. Potential utility of PPARgamma agonists in targeting chronic myeloid leukemia stem cells. Ann Hematol. 2026 Feb 25;105(4):136. doi: 10.1007/s00277-026-06795-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed N. Mabed, Professor study director
Oncology Center Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pioglitazone 15mg in people with Chronic Myelogenous Leukemia, BCR-ABL Positive and CML, Chronic Phase, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of major molecular response(MMR) at 12 months (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04883125, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021.