A Study of Rituximab in Combination With Fludarabine and Cyclophosphamide in Participants With Chronic Lymphocytic Leukemia and Favorable Somatic Status

Roche

Status and phase: Terminated; Phase 4

Conditions: Lymphocytic Leukemia, Chronic

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01271010

ML25136

Details and patient eligibility

About

This multi-center, single-arm study evaluated the efficacy and safety of rituximab in combination with fludarabine and cyclophosphamide in participants with B-cell chronic lymphocytic leukemia (CLL) and favorable somatic status.

Enrollment: 89 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of previously untreated B-cell CLL confirmed immunophenotypically
• For participants, age 60-70 years: Cumulative Illness Rating Scale (CIRS) comorbidity score less than or equal to (</=) 6
• Binet stage B, C or A with progression
• Life expectancy greater than or equal to (>/=) 12 months
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
• Women of child bearing potential and men should agree to use highly reliable contraceptive method throughout the treatment period and within 12 months after treatment completion

Exclusion criteria

• Participants with small-cell lymphoma
• Participants with auto-immune hemolytic anemia
• Concomitant malignant disease during enrollment, except basal cell carcinoma of the skin
• Chemotherapy for concomitant malignant disease given within 12 months prior to study enrollment
• Participants with Richter's Syndrome
• Participants with symptomatic Hepatitis B infection
• Any clinically significant infection that could not be cured prior to enrollment, including Human Immunodeficiency Virus (HIV) infection
• Creatinine clearance less than (<) 30 milliliters per minute (mL/min)
• Participants with congestive heart failure (CHF) New York Heart Association (NYHA) III-IV
• Participants with liver failure and acute hepatitis of any etiology
• Any other medical or mental condition which may preclude from receiving the entire course of protocol specified treatment or signing the informed consent
• History of an anaphylactic reaction to murine antibodies, proteins, or any other ingredient of rituximab
• Pregnancy and breast-feeding women

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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89 participants in 1 patient group

Rituximab + Fludarabine + Cyclophosphamide

Experimental group

Description:

Participants received rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m\^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m\^2 IV or 40 mg/m\^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m\^2 IV or 250 mg/m\^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each.

Treatment:

Drug: Cyclophosphamide

Drug: Fludarabine

Drug: Rituximab