BEAM + 131Iodine-Anti-B1 Radioimmunotherapy and Autologous Hematopoietic Stem Cell Transplantation for the Treatment of Recurrent Non-Hodgkin's Lymphoma
Thirty patients will be enrolled in this study. There will be two administrations of
131I-anti-B1 given to patients, the "dosimetric dose" and the "radioimmunotherapy dose".
The dosimetric dose will consist of an infusion of unlabeled Anti-B1 (450 mg) immediately
followed by an infusion of Anti-B1 (35 mg) which has been trace labeled with 5mCi of
131I-anti-B1. The total whole body dosimetry dose is then calculated over an approximated
one-week time interval from the radioactive clearance data obtained by the Whole Body
anterior and posterior gamma camera scans. Based upon dosimetric data calculations specific
for each individual patient, a radioimmunotherapy dose will be given consisting of an
infusion of unlabeled Anti-B1 (450 mg)immediately followed by an infusion of 35 mg Anti-B1
including a patient specific dose of 131Iodine-Anti-B1. Calculations will be made such that
in a dose escation study, whole body radiation doses of 30, 45, 60, and 75cGy will result
from the administration of the therapeutic activity of 131I-anti-B1. The amount of the
unlabeled Anti-B1 administered is not calculated on a body surface area basis, but is given
to provide an excess of Anti-B1 independent of tumor burden, splenic uptake, or other
causes.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of 131I-anti-B1 radioimmunotherapy when combined with high-dose BEAM or BEAC chemotherapy & HSCT
During treatment
Yes
Julie M Vose, MD
Principal Investigator
University of Nebraska
United States: Food and Drug Administration
165-96
NCT00574509
March 1996
December 2015
Name | Location |
---|---|
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |