Phase I/II Trial of IDEC-Y2B8 Radioimmunotherapy for Treatment of Relapsed or Refractory CD20+B-Cell Non-Hodgkin's Lymphoma
- 1 December 1999
- journal article
- clinical trial
- Published by American Society of Clinical Oncology (ASCO) in Journal of Clinical Oncology
- Vol. 17 (12), 3793-3803
- https://doi.org/10.1200/jco.1999.17.12.3793
Abstract
PURPOSE: Yttrium-90 ibritumomab tiuxetan (IDEC-Y2B8) is a murine immunoglobulin G1 kappa monoclonal antibody that covalently binds MX-DTPA (tiuxetan), which chelates the radioisotope yttrium-90. The antibody targets CD20, a B-lymphocyte antigen. A multicenter phase I/II trial was conducted to compare two doses of unlabeled rituximab given before radiolabeled antibody, to determine the maximum-tolerated single dose of IDEC-Y2B8 that could be administered without stem-cell support, and to evaluate safety and efficacy. PATIENTS AND METHODS: Eligible patients had relapsed or refractory (two prior regimens or anthracycline if low-grade disease) CD20+ B-cell low-grade, intermediate-grade, or mantle-cell non-Hodgkin's lymphoma (NHL). There was no limit on bulky disease, and 59% had at least one mass ≥ 5 cm. RESULTS: The maximum-tolerated dose was 0.4 mCi/kg IDEC-Y2B8 (0.3 mCi/kg for patients with baseline platelet counts 100 to 149,000/μL). The overall response rate for the intent-to-treat population (n = 51) was 67% (26% complete response [CR]; 41% partial response [PR]); for low-grade disease (n = 34), 82% (26% CR; 56% PR); for intermediate-grade disease (n = 14), 43%; and for mantle-cell disease (n = 3), 0%. Responses occurred in patients with bulky disease (≥ 7 cm; 41%) and splenomegaly (50%). Kaplan-Meier estimate of time to disease progression in responders and duration of response is 12.9+ months and 11.7+ months, respectively. Adverse events were primarily hematologic and correlated with baseline extent of marrow involvement with NHL and baseline platelet count. One patient (2%) developed an anti-antibody response (human antichimeric antibody/human antimouse antibody). CONCLUSION: These phase I/II data demonstrate that IDEC-Y2B8 radioimmunotherapy is a safe and effective alternative for outpatient therapy of patients with relapsed or refractory NHL. A phase III study is ongoing.Keywords
This publication has 16 references indexed in Scilit:
- 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.Journal of Clinical Oncology, 1998
- Follow-up of relapsed B-cell lymphoma patients treated with iodine-131-labeled anti-CD20 antibody and autologous stem-cell rescue.Journal of Clinical Oncology, 1998
- Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program.Journal of Clinical Oncology, 1998
- IDEC-C2B8: results of a phase I multiple-dose trial in patients with relapsed non-Hodgkin's lymphoma.Journal of Clinical Oncology, 1997
- Radioimmunotherapy of B-Cell Lymphoma with [131I]Anti-B1 (Anti-CD20) AntibodyNew England Journal of Medicine, 1993
- TREATMENT OF B-CELL LYMPHOMA WITH I-131 LABELED MURINE MONOCLONAL ANTIBODIES.Clinical Nuclear Medicine, 1987
- ANTI-B1 MONOCLONAL ANTIBODY AND COMPLEMENT TREATMENT IN AUTOLOGOUS BONE-MARROW TRANSPLANTATION FOR RELAPSED B-CELL NON-HODGKIN'S LYMPHOMAThe Lancet, 1984
- Treatment of B-Cell Lymphoma with Monoclonal Anti-Idiotype AntibodyNew England Journal of Medicine, 1982
- Modulation of human acute lymphoblastic leukemia antigen induced by monoclonal antibody in vitro.The Journal of Immunology, 1980
- Characterization of a human B lymphocyte-specific antigen.The Journal of Immunology, 1980