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 rec...

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Bibliographic Details
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
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Summary: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.
ISSN:1042-8194
1029-2403
DOI:10.3109/10428194.2014.910654