This is an Open-Label Phase II Study to Investigate the Safety and Efficacy of Rituximab Plus Chlorambucil in Previously Untreated Patients with CD20-Positive B-Cell Chronic Lymphocytic Leukaemia (CLL), conducted in the UK and presented at ASH 2009. First author Peter Hillmen.
A planned interim analysis based on the first 50 patients out of the total 100 patients from 12 centres shows the median age to be 70.5 years (range 48–86), 62% were male and 52% had Binet stage C CLL. The most common adverse events were gastrointestinal disorders. There were 25 serious adverse events reported in 17 patients. The most common were infections. Additionally there were 3 episodes of febrile neutropenia – grade 3 or 4 neutropenia was reported in 40% of patients. Overall response rate on an intent-to-treat analysis was 84%. When compared with the well matched subset of Chlorambucil-treated patients from the UK LRF CLL4 study, the overall response rate was 17.3% higher (95% CI 4.7% - 30.0%), indicating that the Chl-R patients have improved responses. Based on this planned interim analysis, the addition of R to Chl is a feasible combination with no unexpected adverse events. The combination of R and Chl was effective for untreated patients with CLL. It is important to note that the median age of patients in this study was considerably greater than the median age of patients in the UK LRF CLL4 and other large trials in CLL, and more representative of the typical age of patients presenting with CLL in the clinic. The combination of R and Chl was well-tolerated and effective for untreated patients with CLL who cannot tolerate a more intensive regimen, and suggest investigation in a Phase III study is warranted.
This is a trial that I have been pushing for some years and I am glad to say that some of the patients that I was dealing with when I was still practising have been entered into it.