Phase II study of alemtuzumab in chronic lymphoproliferative disorders.

Abstract

BACKGROUND:

Pilot studies showed that alemtuzumab is active in lymphoproliferative disorders. The authors conducted a Phase II trial to evaluate the efficacy and safety of alemtuzumab in advanced or refractory chronic lymphoproliferative disorders.

METHODS:

Seventy-eight patients were enrolled. The most common diagnoses were chronic lymphocytic leukemia (n = 42 patients) and T-cell prolymphocytic leukemia (n = 18 patients). Before entering the study, the patients had received multiple therapies (median, three therapies) and the median time from diagnosis was 7 years. Alemtuzumab was given intravenously at doses of 3 mg, 10 mg, and 30 mg on 3 consecutive days, after which 30 mg was administered 3 times a week. Patients were treated for 4-12 weeks depending on disease response. All patients received prophylactic trimethoprim/sulfamethoxazole and valacyclovir.

RESULTS:

The overall response rate was 35%, the complete response (CR) rate was 13%, and the partial response (PR) rate was 22%. The median duration of response was 18 months for patients achieving a CR and 7 months for patients achieving a PR. The median duration of survival was 25 months for patients who had a response and 12 months for the entire population. Normalization of the lymphocyte count was observed in 84% of patients and resolution of bone marrow involvement was observed in 49% of patients. The most common infusion-related adverse events were fever, rigors, skin rash, nausea, and dyspnea. These were most common during the first week of therapy. Hematologic toxicity was comprised of long-lasting lymphocytopenia and transient neutropenia and thrombocytopenia. Thirty-six patients (46%) experienced at least one episode of fever or infection.

CONCLUSIONS:

Alemtuzumab has a high response rate in patients with chronic lymphoproliferative disorders.

• Authors: Alessandra Ferrajoli, Susan M O'Brien, Jorge E Cortes, Francis J Giles, Deborah A Thomas, Stefan Faderl, Razelle Kurzrock, Susan Lerner, Dimitrios P Kontoyiannis, Michael J Keating
• Journal: Cancer (Cancer) Vol. 98 Issue 4 Pg. 773-8 (Aug 15 2003) ISSN: 0008-543X [Print] United States
• PMID: 12910522 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)
• Copyright: Copyright 2003 American Cancer Society.DOI 10.1002/cncr.11551

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Antibodies, Neoplasm
• Antineoplastic Agents
• Alemtuzumab

Topics

• Adult
• Aged
• Aged, 80 and over
• Alemtuzumab
• Antibodies, Monoclonal (adverse effects, therapeutic use)
• Antibodies, Monoclonal, Humanized
• Antibodies, Neoplasm (adverse effects, therapeutic use)
• Antineoplastic Agents (adverse effects, therapeutic use)
• Humans
• Immunocompromised Host
• Infections (immunology)
• Leukemia (drug therapy, immunology, mortality)
• Leukemia, Lymphocytic, Chronic, B-Cell (drug therapy)
• Leukemia, Prolymphocytic (drug therapy)
• Lymphoma (drug therapy, immunology, mortality)
• Middle Aged
• Survival Rate