Lymphoma, Follicular Clinical Trial
Official title:
A Multi-Center Study to Examine the Pharmacokinetics, Whole Body and Organ Dosimetry, and Biodistribution of Fission-Derived Iodine I 131 Tositumomab for Patients With Previously Untreated or Relapsed Follicular or Transformed Follicular Non-Hodgkin's Lymphoma
Patients will receive a standard 5 mCi dosimetric dose of fission-derived Iodine I 131
Tositumomab. Pharmacokinetic data for the primary endpoint analysis will be derived from
testing done on blood samples drawn at 12 timepoints over the first 7 days following
administration of the dosimetric dose. Whole body gamma camera images will be obtained on
six days following the dosimetric dose. Organ and tumor dosimetry data will be generated
from gamma camera counts of specific organs and tumor. All scans will be examined by an
independent review panel to evaluate biodistribution of the radionuclide.
Using the dosimetric data from three of the six imaging time points and the patient's
weight, a patient-specific activity (mCi) of Iodine-131 will be calculated to deliver the
desired total body dose of radiation (75 cGy). Patients will receive an infusion of
unlabeled Tositumomab (450 mg) immediately followed by an infusion of the patient specific
dose of tellurium-derived Iodine I 131 Tositumomab (35 mg) to deliver a total body dose
(TBD) of 75 cGy. Patients will be followed closely obtaining safety information during the
post-treatment period, and for response and safety at 3,6,and 12 months during the first
year, annually thereafter up to five years, and annually for additional safety and outcomes
information up to 10 years.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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