Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma
Currently, patients with recurrent or primary refractory non-Hodgkin's lymphoma are treated
with second-line chemotherapy (usually 2-3 courses) for the purpose of cytoreduction and to
establish sensitivity to chemotherapy. Thereafter, peripheral blood progenitor cells are
mobilized with cyclophosphamide and granulocyte colony stimulating factor, apheresed and
cryopreserved. The standard high dose regimen consists of augmented carmustine, etoposide
and cyclophosphamide. Unfortunately, there are subgroups of patients with poor outcomes
using autologous transplantation including those with transformed lymphoma as well as
patients who do not attain a minimal disease state due to chemoresistant disease.
Past studies conducted at Stanford have included a group of 17 patients with transformed
lymphoma who received autologous transplants, the median EFS and OS were 1.48 and 2.7 years
respectively with a 7-year survival of only 20%. In comparison, patients with chemosensitive
follicular lymphoma who received the same regimen also had a poor median EFS of 1.3 years,
but the median survival was 6.7 years. The outcomes for patients with
chemotherapy-resistant relapsed NHL is also poor with EFS in the range of 20% in many
studies of autologous transplantation.
These groups of patients have limited disease control and survival with standard
chemotherapy regimens, and although they often have excellent cytoreduction with the
high-dose chemotherapy regimen, relapse remains the primary cause of treatment failure. The
current trial utilizes a similar approach that has been taken with patients with multiple
myeloma, who appear to benefit from an allogeneic graft-versus-tumor effect, using a
combined autologous and non-myeloablative allogeneic transplant regimen to reduce
transplant-related complications. Eligible patients will be treated with high-dose
chemotherapy using BCNU, etoposide and cyclophosphamide with autologous hematopoietic cell
support as a method of cytoreduction. Approximately 60-120 days after the autologous
transplant, patients will receive an allogeneic transplant using a preparative regimen of
total lymphoid irradiation and anti-thymocyte globulin in an attempt to develop a
graft-versus-lymphoma effect.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Event-free survival
Two years after the last participant is enrolled.
Yes
Wen-Kai Weng
Principal Investigator
Stanford University
United States: Institutional Review Board
BMT185
NCT00481832
January 2007
December 2013
Name | Location |
---|---|
Stanford University School of Medicine | Stanford, California 94305-5317 |