A Study of Obinutuzumab Evaluating Efficacy, Safety and Cost of Disease Management in Participants With Chronic Lymphocytic Leukemia and Comorbidities

Roche

Status: Completed

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: Chlorambucil; Drug: Obinutuzumab

Study type: Observational

Funder types: Industry

Identifiers

NCT02915224

ML30133

Details and patient eligibility

About

This multicenter, single arm, non-interventional, observational study will evaluate the efficacy and safety of obinutuzumab in daily clinical practice in participants with chronic lymphocytic leukemia (CLL). The study will also assess cost of disease management. The total length of the study is 42 months.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with untreated CLL and comorbidities, for which the physician has already decided to use obinutuzumab in association with chlorambucil

Exclusion criteria

• Participation in another clinical trial during the study

Trial design

50 participants in 1 patient group

Obinutuzumab

Description:

Participants will receive obinutuzumab as per Summary of Product Characteristics in daily practice along with chlorambucil for 24 months.

Treatment:

Drug: Obinutuzumab

Drug: Chlorambucil