Blood and Marrow Transplant-Related Clinical Trials

The National Marrow Donor Program (NMDP) is committed to research aimed at increasing opportunities for and improving outcomes of bone marrow and cord blood transplants (also called BMT). The NMDP is involved in several transplant-related clinical trials. It is involved in many of these trials as part of the Blood and Marrow Transplant Clinical Trials Network (BMT CTN).

NMDP also conducts research through its partnership with the Medical College of Wisconsin's International Bone Marrow Transplant Registry and Autologous Blood and Marrow Transplant Registry. This partnership, known as the Center for International Blood and Marrow Transplant Research (CIBMTR), makes it easier to design, conduct and support clinical studies that involve large numbers of patients from multiple transplant centers - the types of studies that are needed to answer critical questions in the field of blood and marrow transplantation.

If you are a patient considering a blood or marrow transplant, you may have the option to be part of a clinical trial for one or more parts of your treatment. Your doctor may tell you about a trial, or you may be looking for more treatment options. This page lists current and upcoming transplant-related clinical trials conducted by the NMDP through its partnership in the Center for International Blood and Marrow Transplant Research (CIBMTR) and/or BMT CTN.

Joint NMDP and BMT CTN clinical trials

• Peripheral blood stem cell (PBSC) vs. marrow transplants from matched unrelated donors — A Phase III, randomized, multi-center trial for patients under age 67 with leukemia, myelodysplastic syndrome or myeloproliferative disease. Enrollment began early 2004. For details, see PBSC vs. Marrow Clinical Trial.

NMDP clinical trials

• Filgrastim-Mobilized Peripheral Blood Stem Cells (PBSC) for Primary Allogeneic Transplantation with Unrelated Donors — A multi-center Phase III study to establish and evaluate a system for the collection and evaluation of PBSC as an alternative to bone marrow in the first donation setting.
• Hematopoietic Stem Cells for Second Transplant by Apheresis of Filgrastim Stimulated Donors — A multi-center Phase III study to establish and evaluate a system for the collection and evaluation of PBSC as an alternative to bone marrow in the second donation.

BMT CTN clinical trials

• Fluconazole vs. voriconazole to prevent invasive fungal infections — A Phase III, randomized, multi-center study for allogeneic (related or unrelated donor) PBSC and marrow transplant patients age 2 or older, or cord blood transplant patients ages 2 to 11. Enrollment continuing through 2006. For details, see http://spitfire.emmes.com/
  study/bmt/protocol/0101_protocol/0101_protocol.html.
• Tandem autologous transplants vs. single autologous transplant followed by matched sibling non-myeloablative transplant for multiple myeloma — A Phase III multi-center study for patients age 70 or younger. Enrollment continuing through 2006. For details, see http://spitfire.emmes.com/
  study/bmt/protocol/0102_protocol/0102_protocol.html.
• Autologous vs. non-myeloablative transplants for non-Hodgkin's lymphoma — A Phase II/III multi-center trial for patients age 75 or younger with recurrent low-grade non-Hodgkin's lymphoma. Enrollment beginning summer 2004. For details see http://spitfire.emmes.com/
  study/bmt/protocol/0202_protocol/0202_protocol.html.
• Fludarabine-based Conditioning for Allogeneic Marrow Transplantation from HLA-compatible Unrelated Donors in Severe Aplastic Anemia — A Phase I/II multi-center study for allogeneic marrow transplantation from matched unrelated donors in patients 65 years of age or younger with severe aplastic anemia (SAA). Enrollment beginning summer of 2005.
• Initial Systemic Treatment of Acute GVHD — A Phase II, randomized, multi-center study to define new agents with promising activity against acute GVHD suitable for testing against corticosteroids alone for patients, 65 years of age or younger, who have a new diagnosis of graft-versus-host disease (GVHD) after receiving an allogeneic (donor) stem cell transplant. Enrollment beginning summer of 2005.
• T cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients with AML in First or Second Morphologic Complete Remission — A Phase II multi-center trial for patients 18 to 60 years of age with AML in First or Second remission with an HLA-identical sibling donor assess the efficacy of HLA-identical sibling transplantation using PBSC grafts processed by the CliniMACS system and employing an intensive pre-transplant cytoreductive regimen. Enrollment beginning spring of 2005.
• Rituxan/BEAM vs. Bexxar/BEAM for persistent or relapsed Chemotherapy Sensitive Diffuse Large B-Cell Non-Hodgkin's Lymphoma — A Phase III, multi-center trial, comparing progression-free survival (PFS) after autologous hematopoietic stem cell transplantation using a standard Rituxan plus BEAM transplant regimen versus a regimen adding Bexxar to BEAM in patients 18-80 years of age that have persistent or recurrent diffuse large B-cell lymphoma. Enrollment beginning summer of 2005.

To find information about other transplant-related trials, see Finding a Clinical Trial.