Previously untreated CLL (CLL8)
Proven to drive better outcomes in first-line chronic lymphocytic leukemia (CLL), as shown in a large Phase III trial1
CLL8 TRIAL DESIGN: RITUXAN+FC ×6 cycles vs FC ×6 cycles1–3
- *Binet stage A patients requiring therapy were initially permitted to enter the study but were excluded following the first protocol amendment.2
- FC=fludarabine, dosed at 25 mg/m2/day, and cyclophosphamide, at 250 mg/m2/day, on Days 1 through 3 in both treatment arms. Prior to the first CLL8 protocol amendment, randomization was stratified by site; afterward, randomization was stratified by country and disease stage.3
- NCI-WG=National Cancer Institute-sponsored Working Group; ECOG=Eastern Cooperative Oncology Group; PFS=progression-free survival; R=RITUXAN.
CLL8 Trial of First-Line CLL: Baseline Patient Characteristics2,3†
|Baseline patient characteristics||R-FC (n=408)||FC (n=409)|
|Age range (years)||30-78||36-81|
|Binet stage||A‡ B C||
|ECOG performance status||0 1 2||
- †These patient characteristics are an abbreviated listing of those found in the CLL8 clinical study report.
- ‡Binet stage A patients requiring therapy were initially permitted to enter the study but were excluded following the first protocol amendment.2
The CLL8 trial was not designed or powered to detect a significant difference in PFS by age category. However, exploratory analysis defined by age suggests no observed benefit with the addition of RITUXAN to FC chemotherapy in previously untreated CLL patients 70 years of age or older.
CLL8 Trial—RITUXAN+FC prolonged PFS in first-line CLL1,2
RITUXAN+FC Significantly Improved Median PFS (N=817)1,2
- CI=confidence interval.
- RITUXAN+FC provided a median PFS of 3.3 years in first-line CLL (p<0.01)1
- CR=complete response; ORR=overall response rate.
RITUXAN in combination with FC for previously untreated CLL
- In the CLL8 study of patients with previously untreated CLL, detailed safety data collection was limited to Grade 3 and 4 adverse reactions and serious adverse reactions
- Grade 3 or 4 adverse reactions that occurred more frequently in patients treated with R-FC vs. FC were infusion reactions (9% in the R-FC arm), neutropenia (30% vs. 19%), febrile neutropenia (9% vs. 6%), leukopenia (23% vs. 12%), and pancytopenia (3% vs. 1%)
- The frequency of prolonged neutropenia for patients who received R-FC vs. FC was 8.5% and 5.8% respectively. For patients who did not have prolonged neutropenia, the frequency of late-onset neutropenia for patients who received R-FC vs. FC was 14.8% and 4.3%, respectively
- Grade 3 or 4 adverse reactions that occurred more frequently in R-FC-treated patients ≥70 years of age compared to younger patients were neutropenia (44% vs. 31%), febrile neutropenia (16% vs. 6%), pancytopenia (7% vs. 2%), and anemia (5% vs. 2%)
- RITUXAN® (Rituximab) full prescribing information, Genentech, Inc., 2013.
- Data on file, Genentech, Inc.
- Hallek M, Fischer K, Fingerle-Rowson G, et al. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. Lancet. 2010;376:1164-1174.