A Phase I Study Evaluating Escalating Doses of 90Y-BC8-DOTA (Anti-CD45) Antibody Followed by Autologous Stem Cell Transplantation for Relapsed or Refractory Lymphoid Malignancies
I. To estimate the maximally tolerated dose (MTD) of 90Y-BC8-DOTA (anti-cluster of
differentiation [CD]45) (yttrium-90 anti-CD45 monoclonal antibody BC8) that can be delivered
prior to autologous stem cell transplantation for patients with relapsed/refractory B-cell
non-Hodgkin lymphoma (B-NHL), T-cell NHL (T-NHL), and Hodgkin lymphoma (HL).
I. To optimize the protein dose (antibody [Ab]) to deliver a favorable biodistribution in
the majority of patients.
II. To describe the impact of rituximab concentrations, B-cell depletion, and disease burden
on CD20 and CD45 targeting.
III. To describe response rates and remission durations in relapsed B-NHL, T-NHL, and HL
following administration of myeloablative doses of 90Y-BC8-DOTA prior to autologous stem
cell transplant (ASCT).
IV. To assess the correlation of lymphoma biomarkers with outcomes.
OUTLINE: This is a dose-escalation study of yttrium-90 anti-CD45 monoclonal antibody BC8.
Patients receive indium-111 anti-CD45 monoclonal antibody BC8 intravenously (IV) on day -28
and (if necessary) day -21 to evaluate the antibody's biodistribution. Patients then receive
yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -14. Patients then undergo autologous
peripheral blood stem cell transplantation on day 0.
After completion of study treatment, patients are followed up at 3, 6, and 12 months and
then annually thereafter.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD of yttrium-90 anti-CD45 monoclonal antibody BC8 before stem cell transplant defined as dose-limiting toxicity rate of 25% graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
Up to 30 days after receiving study drug
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|