Journal of immunotherapy (Hagerstown, Md. : 1997) · 2001
Phase I trial of anti-B4-blocked ricin in pediatric patients with leukemia and lymphoma.
Клиническое исследованиеКлиническое исследование I фазыСтатьяМногоцентровое исследованиеПоддержка службы здравоохранения СШАНазвание и аннотация: Перевод пока не подготовлен
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Dinndorf P, Krailo M, Liu-Mares W, Frierdich S, Sondel P, Reaman G
Аннотация
Monoclonal antibodies, specific for antigens expressed on lymphoid malignancies, which have been conjugated to toxins such as ricin, hold promise in the therapy of childhood leukemia and lymphoma. Anti-B4-blocked ricin (anti-B4-bR) is such an agent, and a phase I study of this agent was conducted in children with relapsed or refractory B-lineage leukemia and lymphoma. Anti-B4-bR was given as two 7-day continuous infusions separated by 7 days. Twenty patients were enrolled and 19 received the drug. Two dosage levels (30 and 40 microg/kg per day) were evaluated. Forty micrograms per kilogram per day was the maximally tolerated dose. Dose-limiting toxicity was capillary leak syndrome. Grade 3 reversible elevation in transaminases was also encountered. Human antimouse antibodies or human antiricin antibodies were detected in five patients. No complete remissions or partial remissions were seen.