Fludarabine followed by alemtuzumab consolidation for previously untreated chronic lymphocytic leukemia

Final report of Cancer and Leukemia Group B study 19901

John C. Byrd, Bercedis L. Peterson, Kanti R. Rai, David Hurd, Raymond Hohl, Michael C. Perry, Jon Gockerman, Sreenivasa Nattam, Richard A. Larson

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Abstract

The humanized anti-CD52 monoclonal antibody alemtuzumab is an effective therapy for chronic lymphocytic leukemia (CLL). We examined the impact of alemtuzumab treatment after initial fludarabine treatment for feasibility and safety. Patients (N = 85) with previously untreated symptomatic CLL received fludarabine (25 mg/m2/day) for 5 days every 4 weeks for four cycles followed by 2 months of observation. Patients with stable disease or better response then received alemtuzumab 30 mg three times weekly for 6 weeks either intravenously (IV; cohort 1; N = 39) or subcutaneously (SC; cohort 2; N = 20). Of the 85 evaluable patients enrolled on our study, four (5%) attained a complete response (CR) and 43 (51%) attained a partial response (after fludarabine induction for an overall response rate (ORR) of 55%. Thirty-nine patients received IV alemtuzumab for consolidation with improvement in CR to 27% and ORR to 73%. Twenty patients received SC alemtuzumab consolidation with improvement in CR to 17% and ORR to 69%. Toxicity from IV alemtuzumab included infusion-related reactions and infection. Mild local inflammation was common from SC alemtuzumab but there were virtually no systemic side effects. Nine of 59 (15%) patients had cytomegalovirus (CMV) infections; one patient died. The administration of alemtuzumab as consolidation therapy following an abbreviated fludarabine induction is feasible but requires close monitoring for CMV infection and other infectious events.

Original languageEnglish (US)
Pages (from-to)1589-1596
Number of pages8
JournalLeukemia and Lymphoma
Volume50
Issue number10
DOIs
StatePublished - Nov 11 2009

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B-Cell Chronic Lymphocytic Leukemia
Leukemia
Neoplasms
Cytomegalovirus Infections
alemtuzumab
fludarabine
Therapeutics
Monoclonal Antibodies
Observation
Inflammation
Safety
Infection

All Science Journal Classification (ASJC) codes

  • Hematology
  • Oncology
  • Cancer Research

Cite this

Byrd, John C. ; Peterson, Bercedis L. ; Rai, Kanti R. ; Hurd, David ; Hohl, Raymond ; Perry, Michael C. ; Gockerman, Jon ; Nattam, Sreenivasa ; Larson, Richard A. / Fludarabine followed by alemtuzumab consolidation for previously untreated chronic lymphocytic leukemia : Final report of Cancer and Leukemia Group B study 19901. In: Leukemia and Lymphoma. 2009 ; Vol. 50, No. 10. pp. 1589-1596.
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abstract = "The humanized anti-CD52 monoclonal antibody alemtuzumab is an effective therapy for chronic lymphocytic leukemia (CLL). We examined the impact of alemtuzumab treatment after initial fludarabine treatment for feasibility and safety. Patients (N = 85) with previously untreated symptomatic CLL received fludarabine (25 mg/m2/day) for 5 days every 4 weeks for four cycles followed by 2 months of observation. Patients with stable disease or better response then received alemtuzumab 30 mg three times weekly for 6 weeks either intravenously (IV; cohort 1; N = 39) or subcutaneously (SC; cohort 2; N = 20). Of the 85 evaluable patients enrolled on our study, four (5{\%}) attained a complete response (CR) and 43 (51{\%}) attained a partial response (after fludarabine induction for an overall response rate (ORR) of 55{\%}. Thirty-nine patients received IV alemtuzumab for consolidation with improvement in CR to 27{\%} and ORR to 73{\%}. Twenty patients received SC alemtuzumab consolidation with improvement in CR to 17{\%} and ORR to 69{\%}. Toxicity from IV alemtuzumab included infusion-related reactions and infection. Mild local inflammation was common from SC alemtuzumab but there were virtually no systemic side effects. Nine of 59 (15{\%}) patients had cytomegalovirus (CMV) infections; one patient died. The administration of alemtuzumab as consolidation therapy following an abbreviated fludarabine induction is feasible but requires close monitoring for CMV infection and other infectious events.",
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Fludarabine followed by alemtuzumab consolidation for previously untreated chronic lymphocytic leukemia : Final report of Cancer and Leukemia Group B study 19901. / Byrd, John C.; Peterson, Bercedis L.; Rai, Kanti R.; Hurd, David; Hohl, Raymond; Perry, Michael C.; Gockerman, Jon; Nattam, Sreenivasa; Larson, Richard A.

In: Leukemia and Lymphoma, Vol. 50, No. 10, 11.11.2009, p. 1589-1596.

Research output: Contribution to journalArticle

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