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Assessment of patients response and expression levels of CITED2 and HIF2a genes on adding pioglitazone to imatinib therapy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional no | Active Comparator | Patients treated with both drugs ( imatinib and pioglitazone) |
|
| Control | No Intervention | Historical control (treated with imatinib only) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone 15mg | Drug | pioglitazone (7.5-30 mg) once daily plus imatinib 400 mg 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of treatment on the rate of transformation | Progression into accelerated or blastic phases | 1 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed N. Mabed, Professor | Oncology Center Mansoura University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine | Al Mansurah | Dakahlia Governorate | 35511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41735647 | Derived | 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. |
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| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| D009196 |
| Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001549 | Benzamides |
| D000577 | Amides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D011743 | Pyrimidines |