Refractory B-Cell Non-Hodgkin Lymphoma Clinical Trial
Official title:
A Study Evaluating Escalating Doses of 131I-BC8 (Anti-CD45) Antibody Followed by Autologous Stem Cell Transplantation for Relapsed or Refractory Lymphoid Malignancies
This phase I trial studies the side effects and best dose of iodine I 131 monoclonal antibody BC8 when given before autologous stem cell transplant in treating patients with Hodgkin lymphoma or non-Hodgkin lymphoma that has returned after a period of improvement or does not respond to treatment. Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving iodine I 131 monoclonal antibody BC8 before an autologous stem cell transplant may kill more cancer cells.
PRIMARY OBJECTIVES:
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 for patients with relapsed/refractory B-non-Hodgkin lymphoma (NHL),
T-NHL, or Hodgkin lymphoma (HL).
SECONDARY OBJECTIVES:
I. To optimize the protein dose (antibody [Ab]) to deliver a favorable biodistribution in the
majority of patients.
II. To assess the radiation dose delivered to tumor sites and normal organs by the above
therapy.
III. To evaluate the dose-response relationship of radiation-dose to tumor and clinical
response.
IV. To estimate the overall and progression-free survival of the above regimen in such
patients.
V. To evaluate the toxicity and tolerability of the above therapy.
VI. To evaluate the feasibility of delivering high-dose 131I-BC8 and autologous stem cell
transplantation (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.
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.
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