A Study of Rituximab (MabThera) in Combination With Chemotherapy in Participants With CD20-Positive B-Cell Chronic Lymphocytic Leukemia (CaLLypso)

Roche

Status: Completed

Conditions: Lymphocytic Leukemia, Chronic

Treatments: Drug: Rituximab

Study type: Observational

Funder types: Industry

Identifiers

NCT01609023

ML22235

Details and patient eligibility

About

This observational study will evaluate the safety and efficacy of rituximab in combination with chemotherapy in first- and second-line treatment of participants with cluster of differentiation 20 (CD20)-positive B-cell chronic lymphocytic leukemia. Data will be collected from eligible participants receiving rituximab according to the Summary of Product Characteristics (SPC) during 6 months of treatment.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with CD20-positive B-cell chronic lymphocytic leukemia eligible for first-line or second-line therapy according to the approved SPC

Exclusion criteria

• Contraindications to rituximab therapy according to the approved SPC

Trial design

67 participants in 1 patient group

Rituximab

Description:

Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to SPC and routine clinical practice will be observed for 24 months.

Treatment:

Drug: Rituximab