A Study Evaluating Escalating Doses of 131I-BC8 (Anti-CD45) Antibody Followed by Autologous Stem Cell Transplantation for Relapsed or Refractory Lymphoid Malignancies
I. To estimate the maximally tolerated dose of 131I-BC8 (anti-cluster of differentiation
[CD]45) (iodine I 131 monoclonal antibody BC8) that can be delivered prior to autologous
stem cell transplantation (ASCT) for patients with relapsed/refractory B-non-Hodgkin
lymphoma (NHL), T-NHL, or HL.
I. To optimize the protein dose (Ab) to deliver a favorable biodistribution in the majority
II. To assess the radiation dose delivered to tumor sites and normal organs by the above
III. To evaluate the dose-response relationship of radiation-dose to tumor and clinical
IV. To estimate the overall and progression-free survival of the above regimen in such
V. To evaluate the toxicity and tolerability of the above therapy. VI. To evaluate the
feasibility of delivering high-dose 131I-BC8 and ASCT to B-Cell NHL, T-NHL, and HL patients.
VII. To evaluate the ability to reduce infusion reactions via unlabeled BC8 preinfusion.
OUTLINE: This is a dose-escalation study of iodine I 131 monoclonal antibody BC8.
Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 intravenously
(IV) on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive
up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately
1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0.
After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months and
then annually thereafter.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Estimation of the maximum tolerated dose of I-131-BC8 that can be delivered prior to transplant
Dose escalation/de-escalation will be conducted by the "two-stage" approach introduced by Storer. Escalation will continue until a dose-limiting toxicity (DLT) occurs. A DLT will be defined as a therapy-related grade III or IV Bearman (transplant) toxicity.
Within 30 days post-transplant
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|