Non-Hodgkin's Lymphoma Clinical Trial
Official title:
Phase I, Dose-Escalation Study of Iodine-131 Anti-B1 Antibody For Patients With Previously Treated Non-Hodgkin's Lymphoma With More Than 25% Bone Marrow Involvement
The purpose of this study is to determine the proper dose, effectiveness, and safety of using Iodine-131 Anti-B1 Antibody for the treatment of patients with previously treated non-Hodgkin's lymphoma (NHL) who have greater than 25% bone marrow involvement with lymphoma.
The primary endpoint is to determine the maximum tolerated dose of Iodine-131 Anti B-1
Antibody in patients with previously treated NHL having more than 25% bone marrow
involvement with lymphoma. Secondary endpoints include assessment of response rate, duration
of response, relapse-free survival, time to treatment failure, safety, and survival.
The dose escalation will be started at 45cGy and will be escalated in 10cGy increments until
the maximum tolerated dose in reached.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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