title: A phase II multicenter study of CAMPATH-1H antibody in previously treated patients with nonbulky non-Hodgkin's lymphoma.
abstract: CAMPATH-1H is a humanized antilymphocyte monoclonal antibody (mAb) directed against the CD52 antigen expressed on normal and malignant lymphocytes. We report the results of a multicenter phase II trial using intravenous CAMPATH-1H in previously treated patients with nonbulky non-Hodgkin's lymphoma (NHL) or minimal residual NHL. Sixteen previously treated patients with nonbulky NHL and two patients with minimal residual NHL, were treated with CAMPATH-1H. Changes in peripheral blood lymphocyte subsets were analyzed by multiparameter flow cytometric techniques in eleven patients. The 18 patients enrolled in the studies received CAMPATH-1H for a median duration of 6 weeks (range, 3 to 14 weeks), and a median cumulative dose of 470 mg (range, 180 to 1185 mg). Two of the sixteen patients with nonbulky NHL achieved a complete response (CR) and one patient achieved a partial response (PR). One of the two patients with minimal residual NHL achieved a molecular CR. Infusional complications were seen with the majority of patients but were more common with initial infusions. Significant hematologic toxicity was also observed with grade (3/4) thrombocytopenia (n=10), grade (3/4) neutropenia (n=4) and grade 3 anemia (n=3). Due to excessive infectious complications observed with the patients enrolled, the trials were terminated early. Anti-tumor activity was demonstrated in a small subset of previously treated low-grade lymphoma patients with nonbulky or minimal residual disease. Future studies evaluating the effect of different drug schedules, modes of mAb administration, and concurrent use of prophylactic antibiotics/antiviral/antifungal agents to optimize anti-tumor activity and limit infectious toxicities are planned.
authors.affiliation: Roswell Park Cancer Institute, Buffalo, NY, USA.
authors.forename: A
authors.initials: A
authors.lastname: Khorana
authors.forename: P
authors.initials: P
authors.lastname: Bunn
authors.forename: P
authors.initials: P
authors.lastname: McLaughlin
authors.forename: J
authors.initials: J
authors.lastname: Vose
authors.forename: C
authors.initials: C
authors.lastname: Stewart
authors.forename: M S
authors.initials: MS
authors.lastname: Czuczman
mesh_terms: D000328:Adult; D000368:Aged; D000074323:Alemtuzumab; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000633:toxicity; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm / Q000008:administration & dosage* / Q000633:toxicity; D015703:Antigens, CD / Q000032:analysis / Q000187:drug effects; D000951:Antigens, Neoplasm; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000494:pharmacology / Q000633:toxicity; D001424:Bacterial Infections / Q000209:etiology; D000074301:CD52 Antigen; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005500:Follow-Up Studies; D006023:Glycoproteins / Q000032:analysis / Q000187:drug effects; D006801:Humans; D007116:Immunization, Passive; D016130:Immunophenotyping; D008228:Lymphoma, Non-Hodgkin / Q000150:complications / Q000188:drug therapy*; D008875:Middle Aged; D018365:Neoplasm, Residual / Q000150:complications / Q000188:drug therapy; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm; D015703:Antigens, CD; D000951:Antigens, Neoplasm; D000970:Antineoplastic Agents; D000074301:CD52 Antigen; C000613862:CD52 protein, human; D006023:Glycoproteins; D000074323:Alemtuzumab