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

Chronic Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03228303
• Other study ID #: Jgmaxwell
• Status: Not yet recruiting
• Phase: Early Phase 1
• First received: July 16, 2017
• Last updated: October 7, 2017
• Start date: December 1, 2017
• Est. completion date: August 1, 2020

Study information

• Verified date: October 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Nilotinib vs imatinib in patients with newly diagnosed CML-CP

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 1, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Drug:
• Nilotinib 150 MG [Tasigna]
Nilotinib vs imatinib in patients with newly diagnosed CML-CP
• Imatinib 400mg
Nilotinib vs imatinib in patients with newly diagnosed CML-CP

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Overall survival rate in years	Overall survival rate in years	3 years cutoff
Primary	Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Cholesterol level in mg	cholesterol level in mg	3 years cutoff
Primary	Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Heart state by assessment by ECG	heart state by assessment by ECG	3 years cutoff
Primary	Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Free survival rate in years	free survival rate in years	3 years cutoff