This trial is active, not recruiting.

Condition lymphocytic leukemia, chronic
Treatments cyclophosphamide, fludarabine, rituximab [mabthera/rituxan]
Phase phase 2
Sponsor Hoffmann-La Roche
Start date July 2011
End date July 2017
Trial size 42 participants
Trial identifier NCT01263704, ML25464


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Primary purpose treatment
Masking no masking
150 mg/m2 on Days 1-3 of each 28-day cycle, 6 cycles
12.5 mg/m2 on Days 1-3 of every 28-day cycle, 6 cycles
rituximab [mabthera/rituxan]
375 mg/m2 iv Day 0 of Cycle 1, 500 mg/m2 iv Day 1 of Cycles 2-6

Primary Outcomes

Overall Response Rate (according to National Cancer Institute - Working Group [NCI-WG] guidelines)
time frame: 5 years

Secondary Outcomes

Safety: Incidence of adverse events (especially neutropenic fever, infection rate, number of hospitalization days, thrombocytopenia >/= grade 3, neutropenia >/= grade 3))
time frame: 5 years
Progression-free survival (according to NCI-WG guidelines)
time frame: up to 36 months
Quality of life: Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire
time frame: up to 36 months

Eligibility Criteria

All participants at least 65 years old.

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 CNS involvement of CLL - Impaired renal or hepatic function - HIV positivity, active hepatitis B/C or 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 HBVsAg (either anti-HBS Ab positive or negative) and are positive for HBV-DNA by 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) - ECOG performance status >/= 3

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.