A Phase II Trial Of BEAM/Rituximab/Autologous Hematopoietic Stem Cell Transplantation (AHSCT) For Patients With CD20 Positive Non-Hodgkin's Lymphoma
- Determine the levels of soluble CD20 antigen (sCD20) in the blood before and after
treatment with rituximab and carmustine, cytarabine, etoposide, and melphalan followed
by autologous hematopoietic stem cell transplantation in patients with CD20-positive
B-cell non-Hodgkin's lymphoma.
- Correlate the effect of changes in levels of sCD20 with clinical outcomes in patients
treated with this regimen.
- Determine the response rate in patients treated with this regimen.
- Determine the event-free survival of patients treated with this regimen.
- Determine the toxicity profile of this regimen in these patients.
OUTLINE: Patients receive rituximab IV over approximately 3-4 hours once weekly for 2 weeks
followed 1 week later by hematopoietic stem cell or bone marrow harvest.
Patients then receive a third dose of rituximab IV over approximately 3-4 hours on day -7 or
-6. Patients also receive high-dose chemotherapy comprising carmustine IV on day -6,
cytarabine IV and etoposide IV twice daily on days -5 to -2, and melphalan IV on day -1.
Patients undergo autologous hematopoietic stem cell transplantation on day 0.
Patients who have less than a complete remission at day 100 post-transplantation receive 4
additional doses of rituximab IV over approximately 3-4 hours once weekly for 4 weeks.
Patients are followed at day 100, at 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
evaluation of the relationship between levels of sCD20 in the blood of patients with non-Hodgkin's lymphoma pre and post rituximab/BEAM/autologous peripheral blood progenitor cell transplantation (PBPCT) as they relate to clinical outcomes.
To evaluate levels of soluble CD20 antigen (sCD20) in the blood of patients with non-Hodgkin's lymphoma pre and post rituximab/BEAM/autologous hematopoietic stem cell transplantation (AHSCT), and to examine the effect of changes in levels of sCD20 with clinical outcomes.
pre and post transplant
Robert G Bociek, MD
University of Nebraska
United States: Federal Government
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center||Omaha, Nebraska 68198-7680|