Observational Study of Ibrutinib Use in CLL

Status Recruiting

Clinical Trial Summary

IB-RU-SCOPE is a "routine-clinical practice" oriented cohort observational study of ibrutinib efficacy and safety in approx. 70 patients with chronic lymphocytic leukemia in the Russian Federation

Clinical Trial Description

Ibrutinib is approved in Russia for treatment of CLL patients both in first line and in relapsed/refractory setting. There is a discrepancy in reported ibrutinib toxicity profile, efficacy and tolerability between registrational clinical trials and observational studies, which to some extent may be explained by patient selection in the former. IB-RU-SCOPE is a first "routine-clinical practice" oriented cohort observational study of ibrutinib in CLL in Russia. The study is designed to include all previously untreated and relapsed/refractory CLL patients older than 18 years with active disease, who have recently started or are about to start ibrutinib (both as monotherapy and in combination), and to follow them to a minimum of 18 and a maximum of 36 months. The study is being conducted in approx. 10 Russian hematological centers and aims to include approx. 70 CLL patients. ;

Study Design

Related Conditions & MeSH terms

Chronic Lymphocytic Leukemia
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid

Clinical Trial Details

NCT number	NCT03633045
Study type	Observational
Source	Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Contact	Andrey Zaritskey, MD, PhD
Phone	0078127023765
Email	ibruscope@ya.ru
Status	Recruiting
Phase
Start date	September 1, 2018
Completion date	April 30, 2022

View Details

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