Nilotinib Versus Imatinib in Treatment of Patients With Newly Diagnosed Chronic Myeloid Leukemia

Early Phase 1UnknownNCT03228303

Assiut University100 enrolled

Overview

Nilotinib vs imatinib in patients with newly diagnosed CML-CP

Study size is 100 patients in 2 arms 50 patients in nilotinib ttt 50 patients in imatinib ttt

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Chronic Myeloid Leukemia

Interventions

Nilotinib 150 MG [Tasigna]DRUG

Nilotinib vs imatinib in patients with newly diagnosed CML-CP

Imatinib 400mgDRUG

Nilotinib vs imatinib in patients with newly diagnosed CML-CP

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Overall survival rate in years

Overall survival rate in years

Time frame: 3 years cutoff

Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Cholesterol level in mg

cholesterol level in mg

Time frame: 3 years cutoff

Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Heart state by assessment by ECG

heart state by assessment by ECG

Time frame: 3 years cutoff

Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Free survival rate in years

free survival rate in years

Time frame: 3 years cutoff

Data from ClinicalTrials.gov

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