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A Phase I Study of ⁹⁰Yttrium-Ibritumomab-Tiuxetan in Children and Adolescents with Relapsed/Refractory CD20-Positive Non–Hodgkin's Lymphoma: A Children's Oncology Group Study

Authors' Affiliations: ¹ Columbia University, New York, New York; ² Keck School of Medicine, University of Southern California, Los Angeles, California; ³ Children's Medical Center, Washington, District of Columbia; ⁴ Mayo Clinic, Rochester, Minnesota; ⁵ Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; and ⁶ University of Utah, Health Sciences Center, Salt Lake City, Utah

Requests for reprints: Mitchell S. Cairo, Division of Pediatric Hematology and Blood and Marrow Transplantation, Medicine and Pathology, Columbia University, 3959 Broadway CHN 10-03, New York, NY 10032. Phone: 212-305-8316; Fax: 212-305-8428; E-mail: mc1310{at}columbia.edu.

Purpose: The prognosis for children with recurrent CD20⁺ non–Hodgkin's lymphoma is dismal. A radiolabeled anti-CD20 antibody, ⁹⁰yttrium-ibritumomab-tiuxetan (⁹⁰Y-IT), is Food and Drug Administration approved for adults with recurrent indolent CD20⁺ B cell–non–Hodgkin's lymphoma. There is no data on the safety and feasibility of ⁹⁰Y-IT in refractory childhood CD20⁺ lymphoma.

Experimental Design: Children and adolescents with refractory/relapsed CD20⁺ lymphoma were eligible for this phase I radioimmunotherapy study. Patients (n = 5) received rituximab (250 mg/m² i.v.) on days 0 and 7 and indium-111 ibritumomab-tiuxetan (5 mCi i.v.) on day 0. Dosimetry studies were done on days 0, 1, 3, and 6. Immediately after rituximab on day 7, patients received ⁹⁰Y-IT if dosimetry studies showed <2000 cGy exposure to all solid organs and <300 cGy to marrow, as well as 0.4 mCi/kg in patients with good marrow reserve (n = 3) and 0.1 mCi/kg in patients with poor marrow reserve (after bone marrow transplant; n = 2).

Results: No patients experienced nonhematologic or hematologic dose-limiting toxicity. Human antimurine antibody/human antichimeric antibody incidence was 0%. One patient experienced grade II infusion–related chills associated with rituximab. The following are the means of organ radiation exposure (cGy): kidneys 341 (112-515), liver 345 (83-798), lungs 309 (155-519), marrow 46 (20-78), spleen 565 (161-816), and total body 42 (14-68).

Conclusions: Based on these findings, an expanded investigator-initiated limited institutional phase II study has been designed to further evaluate the safety, tolerability, and response rate with ⁹⁰Y-IT dose stratification based on marrow reserve.