A Study to Compare Mabthera (Rituximab), Fludarabine and Cyclophosphamide to Mabthera and Chlorambucil in Participants With Chronic Lymphocytic Leukemia and Unfavorable Somatic Status

Roche

Status and phase: Terminated; Phase 4

Conditions: Lymphocytic Leukemia, Chronic

Treatments: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Chlorambucil; Drug: Fludarabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01283386

ML25137

Details and patient eligibility

About

This multi-center, randomized study compared the efficacy and safety of MabThera (rituximab) in combination with either fludarabine and cyclophosphamide or with chlorambucil in participants with previously untreated B-cell chronic lymphocytic leukemia and unfavorable somatic status. Participants were randomized to receive Mabthera (375 mg/m2 intravenously [IV] Day 1 of Cycle 1, 500 mg/m2 IV Day 1 Cycles 2-6) with either fludarabine (20 mg/m2 IV or 32 mg/m2 orally Days 1-3) and cyclophosphamide (150 mg/m2 IV or orally Days 1-3) or with chlorambucil (10 mg/m2 orally Days 1-7) for 6 cycles of 28 days. Anticipated time on study treatment was 24 weeks.

Enrollment: 26 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, 60-70 or >70 years of age
• Cumulative Illness Rating Scale (CIRS) comorbidity score >/=7 if patient is 60-70 years old
• Previously untreated B-cell chronic lymphocytic leukemia
• Binet stage B, C or A with progression
• ECOG performance status 0-2

Exclusion criteria

• Small-cell lymphoma
• Autoimmune hemolytic anemia
• Concomitant malignant disease during enrollment, except for basal cell carcinoma of the skin
• Chemotherapy for concomitant malignant disease within 12 months prior to study enrollment
• Richter's syndrome

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

FCR-lite

Experimental group

Description:

Rituximab, fludarabine, and cyclophosphamide

Treatment:

Drug: Fludarabine

Drug: Rituximab

Drug: Cyclophosphamide

LR Therapy

Active Comparator group

Description:

Rituximab and chlorambucile

Treatment:

Drug: Chlorambucil

Drug: Rituximab