A Phase II Study in Poor Risk Diffuse Large B-cell Lymphoma (DLBCL) of Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) Followed by Matched Allogeneic Hematopoietic Transplantation as a Consolidation to Autologous Hematopoietic Cell Transplantation (AHCT)
This purpose of this clinical trial is to develop an alternative treatment for patients with
relapsed diffuse large B cell lymphoma who are not likely to be cured by the conventional
transplantation regimen. This study tests a tandem transplant approach that starts with
transplantation of the patient's own hematopoietic (blood) cells (AHCT) as preparation for
an allogeneic transplantation whereby the blood cells from a matched donor are used to try
to support the patient's immune system to fight the cancer cells. A novel combination of
lymphoma-specific radiation that only impacts the lymphoid organs (lymph nodes and spleen)
and an immune suppressing drug is given to prepare the patient body to receive the donor's
cells. This conditioning regimen is used because it has been shown to reduce the likelihood
of a very common side-effect, known as graft versus host disease, a negative reaction of the
donor's cells against the patient's tissues. By carefully preparing the patient for this
immune-based strategy, it is hoped that an improvement in event-free survival and a
reduction in the risk of disease relapse after AHCT will be seen.
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To estimate event-free survival and toxicity in poor risk recurrent or primary refractory DLBCL treated with TLI and ATG followed by matched allogeneic hematopoietic cell transplantation as a consolidation to AHCT
unknown
Yes
Sandra Jeane Horning
Principal Investigator
Stanford University
United States: Institutional Review Board
BMT186
NCT00482053
October 2006
May 2010
Name | Location |
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Stanford University School of Medicine | Stanford, California 94305-5317 |