Chronic Myeloid Leukemia
Conditions
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
Interventions
DRUGNilotinib 150 MG [Tasigna]
Nilotinib vs imatinib in patients with newly diagnosed CML-CP
DRUGImatinib 400mg
Nilotinib vs imatinib in patients with newly diagnosed CML-CP
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* chronic phase CML not received treatment * Pts with no heart disease * Pts with no abnormal cholesterol level
Exclusion criteria
* Any pts treated before with diff. Treatment * Pts. With past history of heart problems * Pts. With abnormal cholesterol level
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Overall survival rate in years | 3 years cutoff | Overall 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: 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 |
Outcome results
None listed