CAMPATH-1H MONOCLONAL-ANTIBODY IN THERAPY FOR PREVIOUSLY TREATED LOW-GRADE NON-HODGKINS-LYMPHOMAS - A PHASE-II MULTICENTER STUDY

Purpose: CAMPATH-1H is a human immunoglobulin G(1) (IgG(1)) anti-CD52 monoclonal antibody (MAb) that binds to nearly all B-cell and T-cell l ymphomas. We report here the results of a multicenter phase II trial o f CAMPATH-1H in patients with advanced, low-grade non-Hodgkin's lympho ma (NHL) who were previously treated with chemotherapy. Patients and M ethods: Fifty patients who had relapsed (n = 25) alter or were resista nt (n = 25) to chemotherapy were treated with CAMPATH-1H 30 mg adminis tered as a a-hour intravenous (IV) infusion three times weekly for a m aximum period of 12 weeks. Results: Six patients (14%) with B-cell lym phomas achieved a partial remission (PR). Patients with mycosis fungoi des appeared to respond more frequently (50%; four of eight patients, which included two complete remissions [CRs]). Lymphoma cells were rap idly eliminated from blood in 16 of 17 patients (94%). CR in the bone marrow was obtained in 32% of the patients. Lymphoma skin lesions disa ppeared completely in four of 10 patients and partial regression was o btained in three patients. Lymphadenopathy and splenomegaly were norma lized 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 infe ctions were diagnosed in seven patients and nine patients had bacteria l septicemia. Death related to infectious complications occurred in th ree patients. Conclusion: CAMPATH-1H had a significant but limited act ivity in patients with advanced, heavily pretreated NHL. The most pron ounced 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 fo r CAMPATH-1H treatment. (C) 1998 by American Society of Clinical Oncol ogy.