Efficacy and Safety Assessment of NIlotinib in CML Patients With Suboptimal Response on Imatinib Therapy — NISRI  

Myeloid Leukemia, Chronic Clinical Trial

Official title: Efficacy and Safety Assessment of NIlotinib in CML Patients With Suboptimal Response on Imatinib Therapy (NISRI)

Status Terminated

Clinical Trial Summary

whether Nilotinib at the two sequential dosage forms will induce quicker and deeper response in those patients, and if FISH on PB (Peripheral blood) would be an effective way to monitor response compared to conventional cytogenetics on bone marrow (BM) sample

Clinical Trial Description

This is a multicenter, open label trial which will be conducted within Kingdom of saudi Arabia for which CML (Chronic Myeloid Leukemia) patients who meet eligibility criteria and showing sub optimal response to Imatinib therapy as per European leukemia Net ELN 2013 guidelines will be recruited and switched to Nilotinib 300 mg twice a day therapy.

Efficacy assessments of hematologic and cytogenetic response and disease progression, will be performed every 6 months at a minimum, including hematologic analysis, bone marrow cytogenetics, and molecular studies to ensure that nilotinib is being provided to patients who were responding and that patients who progressed could discontinue therapy.

Safety assessments include evaluation of adverse events, hematologic assessment, biochemical testing, cardiac enzyme assessment, serial electrocardiogram evaluation, and physical examination. Adverse events are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0. Survival will be dated from start of nilotinib therapy until death from any cause and censored at last follow-up for patients who were alive.

The data will be summarized with respect to demographic and baseline characteristics, efficacy evaluation, and safety observations and measurements. ;

Related Conditions & MeSH terms

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

• NCT number: NCT02086487
• Study type: Interventional
• Source: King Abdullah International Medical Research Center
• Status: Terminated
• Phase: Phase 4
• Start date: March 2013
• Completion date: August 2016