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

• Published in: Leukemia & lymphoma 2015-02, Vol.56 (2), p.315-323
• Main Authors: Frankfurt, Olga, Ma, Shuo, Gordon, Leo, Winter, Jane N., Horowitz, Jeanne M., Rademaker, Alfred, Weitner, Bing Bing, Peterson, LoAnn C., Altman, Jessica K., Tallman, Martin S., Petrich, Adam, Rosen, Steven T.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Alemtuzumab; Anemia - chemically induced; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - adverse effects; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Exanthema - chemically induced; Female; Fever - chemically induced; Humans; Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy; Leukemia, Lymphocytic, Chronic, B-Cell - pathology; Male; Middle Aged; Neoplasm Staging; Neutropenia; Remission Induction; Rituximab - administration & dosage; Rituximab - adverse effects; Survival Analysis; Time Factors; Treatment Outcome
• ISSN: 1042-8194; 1029-2403
• DOI: 10.3109/10428194.2014.910654

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.