The Blood and Marrow Clinical Trials Network (BMT CTN) is supported by a U10 grant to the National Heart, Lung, and Blood Institute (NHLBI) and NCI, with the NHLBI as the lead institute. This network is managed jointly among NHLBI and NCI/CTEP program officers. The BMT CTN was established in 2001 to conduct large, multi-institutional clinical trials addressing important issues in hematopoietic stem cell transplantation (HSCT). The participating BMT CTN investigators collaborate to implement and complete well-designed clinical trials of high scientific merit, offering trial participation to patients in all regions of the United States. The network is composed of 16 clinical core centers and a data and coordinating center (DCC) as well as a large number of affiliate clinical centers. A steering committee, composed of a chair and a lead transplant physician from each of the core sites, reviews concepts of protocols that are presented at regularly scheduled meetings from member institutions or outside institutions, as well as applications for ancillary site participation in clinical trials. The DCC is a consortium of three collaborative organizations, the Center for International Blood and Marrow Transplant Research (CIBMTR), which maintains an extensive database of clinical information on autologous, related, and unrelated donor transplants; the National Marrow Donor Program, which communicates with a large network of donor and collection sites; and the EMMES Corporation, which has extensive expertise in managing multi-center clinical trials and in statistical support for clinical trial design and analysis.
The topics under study by the BMT CTN include: what are the best stem cell donor sources (for example, peripheral blood vs. bone marrow); issues surrounding regimen toxicity and infection, such as prevention and treatment of graft vs. host disease after allogeneic transplantation; and, disease-specific transplant questions, including protocols for treatment of acute and chronic leukemias, lymphoma, and multiple myeloma. There are currently 15 protocols open for accrual in the BMT CTN, with 11 protocols that are now closed to accrual and are either in final patient treatment stages, in final data analysis, or have completed data analysis and have had manuscripts published. All but one of the 11 protocols reached their accrual goals before closing. There are also three protocols in the late development stages. A hallmark of recent progress in the BMT CTN is collaborations that have been set up with the NCI Cooperative Groups to complete trials in a timely fashion in HSCT for hematologic malignancies. For instance, the BMT CTN has collaborated with CALGB to help accrue patients to a transplant trial for patients with multiple myeloma as well as on a reduced intensity conditioning trial for elderly AML patients; with SWOG on a trial for patients with recurrent Hodgkin Disease; and with COG to enter patients on a trial comparing single vs. double cord blood transplant in children. Furthermore, working groups in multiple myeloma and lymphoma, organized by the BMT CTN and consisting of members of the group transplant committees and the BMT CTN, have jointly designed new protocols in each of these diseases, illustrating the cooperative and collaborative nature of these organizations for moving forward transplantation as curative therapy for hematologic diseases in the United States in the years to come.
For further information, including a listing and description of the clinical protocols open for accrual and how to participate in a trial as an affiliate center, see: https://web.emmes.com/study/bmt2/