Phase II study of alemtuzumab–rituximab therapy in previously untreated patients with chronic lymphocytic leukemia: short- and long-term outcomes

Abstract

We investigated the safety, efficacy, and long-term outcomes of alemtuzumab and rituximab (AR) combination therapy in previously untreated patients with CLL. Thirty patients, ages 28–80 years, 47% older than 60 years, 90% Rai clinical stages II–IV, and 67% without favorable cytogenetics received AR. Based on the NCI-WG 1996 criteria, OR was 100%, with 60% CR. With CT scans OR was 70%, with 23% CR, 47% PR, and 30% SD. Sixty-seven percent of patients showed no evidence of MRD in the bone marrow by 6-color flow cytometry. Median PFS, TFS, and 5-year OS were 24.4, 50.7 months, and 80%, respectively. Grade 3/4 neutropenia and thrombocytopenia were reported in 30% and 7% of patients, respectively. CMV reactivation, asymptomatic in all but one patient, occurred in 8 patients. Immunotherapy with alemtuzumab and rituximab results in robust responses and long asymptomatic therapy-free intervals. It is well tolerated with infrequent, predictable, and easily managed complications.

Keywords::

• CLL
• immunotherapy
• alemtuzumab
• rituximab

Acknowledgements

The authors are grateful to Jennifer Nam and Sara Duffey for their help with data management.

This clinical protocol was supported by research funding from Sanofi US (originally Genzyme).

Potential conflict of interest:

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