This application is a consortium from the University of Nebraska Medical Center (UNMC) bone marrow transplant (BMT) program in collaboration with the University of Kansas Medical Center (KUMC) BMT program which will be designated the "Nebraska/Kansas Blood and Marrow Transplant Research Network".
The specific aims of the application are: 1) To form a BMT consortium from UNMC and KUMC that collaborates on the conduct of clinical trials for autologous and allogeneic hematopoietic stem cell transplantation (HSCT). 2) To initiate a phase III randomized clinical trial for patients with relapsed diffuse large B-cell lymphoma using Rituximab/Carmustine, Etoposide, Cytarabine, and Melphalan (R-BEAM) or Bexxar/BEAM + autologous HSCT as the control and R-BEAM or Bexxar/BEAM + autologous HSCT + lenalidomide maintenance as the experimental arm (2:1 randomization). 3) To analyze the results according to the germinal center type (GOB) vs. activated B-cell type (ABC) and to test cytokines including vascular endothelial growth factor (VEGF), soluble Interleukin-2 receptor (slL2r), lnterleukein-12 (ILI 2), and tumor necrosis factor alpha (TNFa) in the post transplant period and correlate the results with the event-free survival (EFS) and overall survival (OS) of the patients on the study. The UNMC/KUMC consortium will bring together two strong clinical and research BMT programs that are geographically in close proximity which will allow for easy collaborations and meetings together frequently. However, the centers are far enough apart so that the healthcare delivery systems are not overlapping. Special expertise available at the two centers is complimentary with physicians at UNMC having expertise in lymphoma, autologous stem cell transplantation, and novel therapies used during stem cell transplantation. Physicians at KUMC have expertise in allogeneic stem cell transplantation, alternative donor transplants, and graft-versus-host disease. This combination of expertise, patient care, research, and teaching is a strong backbone for our consortium from the UNMC BMT program in collaboration with the KUMC BMT program.
Hematopoietic stem cell transplantation is a very useful treatment for patients with a variety of malignancies;however, advancements can only be made with large stage ll/lll clinical trials. The BMT/CTN including our consortium will be the only clinical cooperative group to accomplish this goal.