A Phase I Study of Bexxar® (Tositumomab and 131I-Tositumomab) Radioimmunotherapy in Patients With Relapsed or Residual CD20 Antigen-Expressing B-Cell Lymphomas Following Autologous Hematopoietic Stem Cell Transplantation
High-dose chemotherapy followed by autologous stem cell transplantation (ASCT) has become
the standard of care for relapsed/refractory chemotherapy-sensitive non-Hodgkin's lymphomas
(NHL). However, one-half to two-thirds of such patients will relapse after ASCT, with
subsequent poor prognosis, and new therapies are urgently needed for this patient
population. Radioimmunotherapy (RIT) as a single agent therapy in patients with CD20
antigen-expressing relapsed or refractory low-grade, follicular, or transformed NHL has
demonstrated overall response rates of 60-80% and has been approved by the FDA for use in
this setting. While RIT is currently under investigation as a component of conditioning
regimens for ASCT, the safety and efficacy of RIT after ASCT has not yet been well
described. We will conduct a single-center Phase I dose-escalation trial of Bexxar
(Tositumomab and 131I Tositumomab) for treatment of relapsed or residual CD20
antigen-expressing B-cell lymphomas following ASCT. Our primary aim will be to determine
the safety, dose-limiting toxicity, and maximum tolerated dose of Bexxar in this post-ASCT
patient population. Our secondary aim will be to describe the overall response rate,
progression-free survival, time to treatment failure, and overall survival. Should Bexxar
prove to be safe in this population, subsequent trials will be designed to investigate
further the efficacy of RIT in the post-transplant setting.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
dose-limiting toxicity
Week 7 after Bexxar
Yes
Stephen J. Schuster, MD
Principal Investigator
Abramson Cancer Center, University of Pennsylvania
United States: Institutional Review Board
UPCC 18406
NCT00434629
February 2007
Name | Location |
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Abramson Cancer Center, University of Pennsylvania | Philadelphia, Pennsylvania 19104 |