Nilotinib Versus Imatinib in Treatment of Patients With Newly Diagnosed Chronic Myeloid Leukemia
Early Phase 1
- Conditions
- Chronic Myeloid Leukemia
- Interventions
- Registration Number
- NCT03228303
- Lead Sponsor
- Assiut University
- Brief Summary
Nilotinib vs imatinib in patients with newly diagnosed CML-CP
- Detailed Description
Study size is 100 patients in 2 arms 50 patients in nilotinib ttt 50 patients in imatinib ttt
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- chronic phase CML not received treatment
- Pts with no heart disease
- Pts with no abnormal cholesterol level
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Exclusion Criteria
- Any pts treated before with diff. Treatment
- Pts. With past history of heart problems
- Pts. With abnormal cholesterol level
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chronic phase CML treated by nilotinib Nilotinib 150 MG [Tasigna] Newly diagnosed Chronic phase CML treated by imatinib Imatinib 400mg Newly diagnosed
- Primary Outcome Measures
Name Time Method Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Heart state by assessment by ECG 3 years cutoff heart state by assessment by ECG
Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Free survival rate in years 3 years cutoff free survival rate in years
Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Cholesterol level in mg 3 years cutoff cholesterol level in mg
Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Overall survival rate in years 3 years cutoff Overall survival rate in years
- Secondary Outcome Measures
Name Time Method