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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
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: This phase II trial is studying how well monoclonal antibody therapy, chemotherapy, and peripheral stem cell transplant work in treating patients with relapsed or refractory non-Hodgkin's lymphoma.
OBJECTIVES: * 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.
Age
19 - 70 years
Sex
ALL
Healthy Volunteers
No
UNMC Eppley Cancer Center at University of Nebraska Medical Center
Omaha, Nebraska, United States
Start Date
April 1, 2000
Primary Completion Date
September 1, 2005
Completion Date
December 16, 2014
Last Updated
September 1, 2023
50
ACTUAL participants
carmustine
DRUG
cytarabine
DRUG
etoposide
DRUG
melphalan
DRUG
peripheral blood stem cell transplantation
PROCEDURE
tositumomab and iodine I 131 tositumomab
RADIATION
Lead Sponsor
University of Nebraska
NCT07388563
NCT05139017
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