An Observational Study Examining the Effect of Added MabThera Therapy in Patients With Untreated Chronic Lymphocytic Leukemia

Roche

Status: Completed

Conditions: Chronic Lymphocytic Leukemia

Study type: Observational

Funder types: Industry

Identifiers

NCT02080884

ML29201

Details and patient eligibility

About

This study will examine the effectiveness of MabThera therapy added to a standard chemotherapy regimen for the treatment of previously untreated chronic lymphocytic leukemia (CLL). Patients who have received a single prior MabThera plus chemotherapy treatment are eligible. The overall response rate of patients treated for approximately 5 months (as per current label guidelines) will be analysed according to various factors (i.e., age, concurrent treatment, and chromosomal abnormalities).

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with first-line CLL having received only 1 cycle of MabThera chemotherapy
• aged >/= 18 years

Exclusion criteria

• Pregnant or breast-feeding
• Receipt of an investigational drug within 30 days prior to entering the study

Trial design

150 participants in 1 patient group

CLL patients on Mabthera (rituximab)