| Title | Epratuzumab, a humanized anti-CD22 antibody, in aggressive non-Hodgkin's lymphoma: phase I/II clinical trial results. |
| Publication Type | Journal Article |
| Year of Publication | 2004 |
| Authors | Leonard JP, Coleman M, Ketas JC, Chadburn A, Furman R, Schuster MW, Feldman EJ, Ashe M, Schuster SJ, Wegener WA, Hansen HJ, Ziccardi H, Eschenberg M, Gayko U, Fields SZ, Cesano A, Goldenberg DM |
| Journal | Clin Cancer Res |
| Volume | 10 |
| Issue | 16 |
| Pagination | 5327-34 |
| Date Published | 2004 Aug 15 |
| ISSN | 1078-0432 |
| Keywords | Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antigens, CD, Antigens, Differentiation, B-Lymphocyte, Antineoplastic Agents, Cell Adhesion Molecules, Combined Modality Therapy, Dose-Response Relationship, Drug, Female, Follow-Up Studies, Half-Life, Humans, Infusions, Intravenous, Lectins, Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Male, Middle Aged, Neoplasm Staging, Safety, Sialic Acid Binding Ig-like Lectin 2, Time Factors |
| Abstract | PURPOSE: We conducted a single-center, dose-escalation study evaluating the safety, pharmacokinetics, and efficacy of epratuzumab, an anti-CD22 humanized monoclonal antibody, in patients with aggressive non-Hodgkin's lymphoma. EXPERIMENTAL DESIGN: Epratuzumab was administered once weekly for 4 weeks at 120-1000-mg/m2 doses to 56 patients [most (n = 35) with diffuse large B-cell lymphoma]. RESULTS: Patients were heavily pretreated (median, 4 prior therapies), 25% received prior high-dose chemotherapy with stem cell transplant, and 84% had bulky disease (> or =5 cm). Epratuzumab was well tolerated, with no dose-limiting toxicity. Most (95%) infusions were completed within 1 h. The mean serum half-life was 23.9 days. Across all dose levels and histologies, objective responses (ORs) were observed in five patients (10%; 95% confidence interval, 3-21%), including three complete responses. In patients with diffuse large B-cell lymphoma, 15% had ORs. Overall, 11 (20%) patients experienced some tumor mass reduction. Median duration of OR was 26.3 weeks, and median time to progression for responders was 35 weeks. Two responses are ongoing at > or =34 months, including one rituximab-refractory patient. CONCLUSIONS: These data demonstrate that epratuzumab has a good safety profile and exerts antitumor activity in aggressive non-Hodgkin's lymphoma at doses of > or =240 mg/m2, thus warranting further evaluation in this clinical setting. |
| DOI | 10.1158/1078-0432.CCR-04-0294 |
| Alternate Journal | Clin Cancer Res |
| PubMed ID | 15328168 |
| Grant List | K23 RR16814-02 / RR / NCRR NIH HHS / United States |
Related Faculty:
Amy Chadburn, M.D.