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

Assiut University

Status and phase: Unknown; Early Phase 1

Conditions: Chronic Myeloid Leukemia

Treatments: Drug: Nilotinib 150 MG [Tasigna]; Drug: Imatinib 400mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03228303

Jgmaxwell

Details and patient eligibility

About

Nilotinib vs imatinib in patients with newly diagnosed CML-CP

Full description

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups

Chronic phase CML treated by nilotinib

Active Comparator group

Description:

Newly diagnosed

Treatment:

Drug: Nilotinib 150 MG [Tasigna]

Chronic phase CML treated by imatinib

Active Comparator group

Description:

Newly diagnosed

Treatment:

Drug: Imatinib 400mg