A Study of MabThera/Rituxan (Rituximab) in Combination With Fludarabine And Cyclophosphamide as Primary Therapy in Elderly Patients With Chronic Lymphocytic Leukemia

Roche

Status and phase: Completed; Phase 2

Conditions: Lymphocytic Leukemia, Chronic

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01263704

ML25464

Details and patient eligibility

About

This single arm, open-label study will assess the safety and efficacy of low dose fludarabine and cyclophosphamide in combination with standard dose MabThera/Rituxan (rituximab) as primary therapy in elderly patients (>/= 65 years) with chronic lymphocytic leukemia. Patients will receive six 28-day cycles of treatment with Mabthera/Rituxan (375 mg/m2 intravenously [iv] Day 0 of cycle 1, 500 mg/m2 iv Day 1 of cycles 2-6), fludarabine (12.5 mg/m2/d iv Days 1-3, cycles 1-6) and cyclophosphamide (150 mg/m2/d iv Days 1-3, cycles 1-6). Anticipated time on study treatment is 6 months, with a 30-month follow-up period.

Enrollment: 42 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >/= 65 years of age
• Previously untreated B-cell chronic lymphocytic leukemia (CLL)
• Binet stage C or active Binet stage A and B disease

Exclusion criteria

• Prior treatment for CLL
• CLL with transformation (Richter's syndrome)
• Suspected or known central nervous system (CNS) involvement of CLL
• Impaired renal or hepatic function
• Human Immunodeficiency Virus (HIV) positivity, active hepatitis B/C or Hepatitis B Virus (HBV) surface antigen positive, or any active or uncontrolled infections
• Patients with anti-HBV core antibodies (past infection with HBV) but who are negative for Hepatitis B Virus Surface Antigen (HBVsAg) (either anti-HBS Ab positive or negative) and are positive for HBV- Deoxyribonucleic acid (DNA) by Polymerase chain reaction (PCR) analysis
• Concomitant diseases requiring chronic steroid administration
• Active second malignancy within the 2 years prior to study (except for non-melanoma skin cancer and in situ cervix or breast or prostate carcinoma)
• Eastern Cooperative Oncology Group (ECOG) performance status >/= 3

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Rituximab plus Fludarabine and Cyclophosphamide

Experimental group

Description:

Elderly participants with chronic lymphocytic leukemia (CLL) will receive combination treatment with low-dose fludarabine and cyclophosphamide combined with standard-dose of rituximab for 6 months. Treatment is followed by a follow up period of 36 months.

Treatment:

Drug: Rituximab

Drug: Fludarabine

Drug: Cyclophosphamide