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

• Status: Terminated
• Trial end date: 2016-05-04
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Rituximab; Vidarabine

Criteria

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 (
• 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