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


Authors: Frankfurt, O.; Ma, S.; Gordon, L.; Winter, J. N.; Horowitz, J. M.; Rademaker, A.; Weitner, B. B.; Peterson, L. C.; Altman, J. K.; Tallman, M. S.; Petrich, A.; Rosen, S. T.
Article Title: 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. © 2014 Informa UK, Ltd.
Keywords: adult; clinical article; aged; overall survival; fatigue; neutropenia; cancer growth; diarrhea; drug efficacy; drug safety; rituximab; cancer staging; anorexia; cancer immunotherapy; progression free survival; computer assisted tomography; drug eruption; nephrotoxicity; phase 2 clinical trial; anemia; nausea; thrombocytopenia; drug dose escalation; drug fever; prednisolone; immunotherapy; minimal residual disease; paracetamol; pancytopenia; second cancer; chronic lymphatic leukemia; bacterial infection; cytomegalovirus infection; lymphadenopathy; cytomegalovirus; alemtuzumab; cll; hypocalcemia; virus reactivation; diphenhydramine; hypertransaminasemia; very elderly; human; male; female; priority journal; article
Journal Title: Leukemia and Lymphoma
Volume: 56
Issue: 2
ISSN: 1042-8194
Publisher: Taylor & Francis Group  
Date Published: 2015-02-01
Start Page: 315
End Page: 323
Language: English
DOI: 10.3109/10428194.2014.910654
PROVIDER: scopus
PUBMED: 24707943
DOI/URL:
Notes: Export Date: 2 April 2015 -- Source: Scopus
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  1. Martin Stuart Tallman
    649 Tallman