CHAIROS Study A Study of MabThera/Rituxan (Rituximab) Maintenance Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Naive to Chemotherapy

Roche

Status and phase: Completed; Phase 2

Conditions: Lymphocytic Leukemia, Chronic

Treatments: Drug: rituximab [MabThera/Rituxan]; Drug: cyclophosphamide; Drug: fludarabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02013817

ML18434

Details and patient eligibility

About

This study will evaluate the efficacy and safety of intense combination treatment including MabThera/Rituxan (rituximab), followed by MabThera/Rituxan maintenance therapy in patients with B-cell CLL who are naive to chemotherapy. The anticipated time on study treatment is 2.5 years.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >/= 18 years of age
• B-cell CLL
• No previous chemotherapy, radiotherapy, or immunotherapy

Exclusion criteria

• Reduced organ function, or bone marrow dysfunction not due to CLL
• Patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer
• Patients with a history of severe cardiac disease.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

MabThera/Rituxan

Experimental group

Treatment:

Drug: rituximab [MabThera/Rituxan]

Drug: cyclophosphamide

Drug: fludarabine