NCT01263704

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

A Phase II, Multicenter, Single Arm Study to Determine the Efficacy and Safety of Low Dose Fludarabine and Cyclophosphamide Combined With Standard Dose Rituximab as Primary Therapy in Elderly Untreated Patients (>/=65 Years Old) With Chronic Lymphocytic Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Lymphocytic Leukemia, Chronic

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	150 milligrams per square meter (mg/m\^2) intravenously (IV) on Days 1-3 of each 28-day cycle for 6 cycles
DRUG	Fludarabine	12.5 mg/m\^2 IV on Days 1-3 of every 28-day cycle for 6 cycles
DRUG	Rituximab	375 mg/m\^2 IV Day 0 of Cycle 1, 500 mg/m\^2 IV Day 1 of Cycles 2-6. Each cycle was 28 days.

Timeline

• Start date: 2011-07-17
• Primary completion: 2017-04-03
• Completion: 2017-04-03
• First posted: 2010-12-21
• Last updated: 2018-04-23
• Results posted: 2018-04-23

Locations

12 sites across 1 country: Israel

Regulatory

• FDA-regulated drug study