Chronic Myelogenous Leukemia, BCR-ABL Positive, CML, Chronic Phase
Conditions
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.
Interventions
pioglitazone (7.5-30 mg) once daily plus imatinib 400 mg 6 months
Sponsors
Mansoura University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of major molecular response(MMR) at 12 months | 1 year | Percentage of patients obtaining MMR at 12 months |
| Impact of treatment on the expression levels of stemness genes | 6 months | Follow up the expression of CITED2 and HIF2a genes pattern |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of treatment on the rate of transformation | 1 years | Progression into accelerated or blastic phases |
Countries
Egypt
Outcome results
None listed