Journal of Clinical Oncology, Vol 16, 3257-3263, Copyright © 1998 by American Society of Clinical Oncology
CAMPATH-1H monoclonal antibody in therapy for previously treated low- grade non-Hodgkin's lymphomas: a phase II multicenter study. European Study Group of CAMPATH-1H Treatment in Low-Grade Non-Hodgkin's Lymphoma
J Lundin, A Osterborg, G Brittinger, D Crowther, H Dombret, A Engert, A Epenetos, C Gisselbrecht, D Huhn, U Jaeger, J Thomas, R Marcus, N Nissen, C Poynton, E Rankin, R Stahel, M Uppenkamp, R Willemze and H Mellstedt
Department of Oncology, Karolinska Hospital, Stockholm, Sweden.
PURPOSE: CAMPATH-1H is a human immunoglobulin G1 (IgG1) anti-CD52
monoclonal antibody (MAb) that binds to nearly all B-cell and T-cell
lymphomas. We report here the results of a multicenter phase II trial of
CAMPATH-1H in patients with advanced, low-grade non-Hodgkin's lymphoma
(NHL) who were previously treated with chemotherapy. PATIENTS AND METHODS:
Fifty patients who had relapsed (n=25) after or were resistant (n = 25) to
chemotherapy were treated with CAMPATH-1H 30 mg administered as a 2-hour
intravenous (i.v.) infusion three times weekly for a maximum period of 12
weeks. RESULTS: Six patients (14%) with B- cell lymphomas achieved a
partial remission (PR). Patients with mycosis fungoides appeared to respond
more frequently (50%; four of eight patients, which included two complete
remissions [CRs]). Lymphoma cells were rapidly eliminated from blood in 16
of 17 patients (94%). CR in the bone marrow was obtained in 32% of the
patients. Lymphoma skin lesions disappeared completely in four of 10
patients and partial regression was obtained in three patients.
Lymphadenopathy and splenomegaly were normalized in only 5% and 15% of
patients, respectively. Lymphopenia (< 0.5 x 10(9)/L) occurred in all
patients. World Health Organization (WHO) grade IV neutropenia occurred in
14 patients (28%). Opportunistic infections were diagnosed in seven
patients and nine patients had bacterial septicemia. Death related to
infectious complications occurred in three patients. CONCLUSION: CAMPATH-1H
had a significant but limited activity in patients with advanced, heavily
pretreated NHL. The most pronounced effects were noted in the blood and
bone marrow and in patients with mycosis fungoides. The risk for serious
infectious complications needs to be considered for severely ill patients
who are evaluated for CAMPATH-1H treatment.
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