Phase II Poor Risk Diffuse Large B-cell Lymphoma (DLBCL) of Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) Followed by Matched Allogeneic Hematopoietic Transplantation as Consolidation to Autologous Hematopoietic Cell Transplantation (AHCT)
|ClinicalTrials.gov Identifier: NCT00482053|
Recruitment Status : Completed
First Posted : June 4, 2007
Last Update Posted : September 14, 2010
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, B-Cell Blood and Marrow Transplant (BMT) Lymphomas: Non-Hodgkin Diffuse Large B-Cell||Procedure: Total lymphoid irradiation (TLI) Drug: Anti-thymocyte globulin (ATG) Procedure: Allogeneic hematopoietic cell transplantation Procedure: Autologous hematopoietic cell transplantation (AHCT)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||October 2006|
|Primary Completion Date :||May 2010|
|Study Completion Date :||May 2010|
- 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
- To evaluate the kinetics of donor hematopoietic cell engraftment and chimerism.
- To evaluate the incidence and extent of chronic GVHD.
- To evaluate the overall and transplant related mortality rate.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00482053
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Sandra Jeane Horning||Stanford University|