Expanded Access Study of Iodine-131 Anti-B1 Antibody for Relapsed/Refractory Low-Grade and Transformed Low-Grade Non-Hodgkin's Lymphoma
OBJECTIVES: I. Determine the efficacy and safety of iodine I 131 monoclonal antibody anti-B1
in patients with relapsed or refractory, low grade or transformed low grade B-cell
non-Hodgkin's lymphoma.
OUTLINE: On day 1, patients receive unlabeled monoclonal antibody anti-B1 (MOAB anti-B1) IV
over 1 hour followed by a tracer dose of iodine I 131 MOAB anti-B1 IV over 30 minutes to
determine biodistribution and a therapeutic dose of iodine I 131 MOAB anti-B1. Patients
receive unlabeled MOAB anti-B1 IV over 1 hour followed by a therapeutic dose of iodine I 131
MOAB anti-B1 IV over 30 minutes on day 8. Patients are followed at weeks 13 and 25 and then
every 6 months for up to 2 years.
PROJECTED ACCRUAL: Expanded Access Trial, no maximum accrual
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Expanded Access
The primary objective of this stud is to make Iodin-131 Anti-B1 Antibody more broadly available to patients
Study completion
No
Julie M. Vose, MD
Study Chair
University of Nebraska
United States: Federal Government
259-98
NCT00004874
November 1998
November 2012
Name | Location |
---|---|
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |