BEAM Plus Iodine-131 Anti-B1 Antibody and Autologous Hematopoietic Stem Cell Transplantation for Treatment of Recurrent Diffuse Large B-Cell Non-Hodgkin's Lymphoma
- Compare the response rates and time to treatment failure in patients with relapsed or
refractory non-Hodgkin's lymphoma treated with iodine I 131 monoclonal antibody
anti-B1, followed by high-dose carmustine, etoposide, cytarabine, and melphalan (BEAM),
and autologous peripheral blood stem cell transplantation (APBSCT) vs historical
control patients treated with high-dose BEAM or carmustine, etoposide, cytarabine, and
cyclophosphamide and APBSCT.
- Determine the safety of this regimen in these patients.
OUTLINE: Autologous peripheral blood stem cells (PBSC) are harvested and selected for CD34+
cells or granulocyte macrophage colony-forming units. On day -19, patients receive unlabeled
monoclonal antibody anti-B1 (MOAB anti-B1) IV followed by a dosimetric dose of iodine I 131
MOAB anti-B1 IV over 20 minutes. On day -12, patients receive unlabeled MOAB anti-B1 IV
followed by a therapeutic dose of iodine I 131 MOAB anti-B1 IV over 20 minutes. Patients
then receive high-dose chemotherapy comprising carmustine IV on day -6, etoposide IV and
cytarabine IV twice daily on days -5 to -2, and melphalan IV on day -1. Patients undergo
autologous PBSC transplantation on day 0.
Patients are followed at days 30 and 100, at 6 months, and then annually thereafter.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 5 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
event free survival rate
100 days post transpat and at yearly intervals
Julie M. Vose, MD
University of Nebraska
United States: Food and Drug Administration
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center||Omaha, Nebraska 68198-7680|