Blood and Marrow Clinical Trials Network
The Blood and Marrow Clinical Trials Network (BMT CTN) is supported by a U10 grant from the 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 October of 2001 to conduct large, multi-institutional clinical trials addressing important issues in hematopoietic stem cell transplantation (HCT). 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 20 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 3 collaborative organizations: a) the Center for International Blood and Marrow Transplant Research, which maintains an extensive database of clinical information on autologous, related, and unrelated donor transplants, b) the National Marrow Donor Program, which communicates with a large network of donor and collection sites, and c) the EMMES corporation, which has extensive expertise in managing multi-center clinical trials and in statistical support for clinical trial design and analysis.
The BMT CTN has launched 38 protocols and has completed accrual to 26 trials, accruing almost 8,000 patients to trials from more than 100 centers. There are currently 12 protocols open for accrual in the BMT CTN, and there are 10 more protocols anticipated to be activated in late 2015 or early-mid 2016. The areas of study have included testing optimal graft sources, acute and chronic graft vs. host disease, optimal conditioning regimens, and disease control to prevent recurrence. The BMT CTN has collaborated with the NCI-funded AIDS Malignancy Consortium to test in two trials the use of either autologous or allogeneic transplant for HIV-infected patients with lymphoma. A hallmark of progress in the BMT CTN is the collaborations with the former NCI cooperative groups (now NCTN) to complete trials in a timely fashion in HCT for hematologic malignancies. Specifically, the BMT CTN collaborated with the one of the former cooperative groups (CALGB, now subsumed into the NCTN) to help accrue patients to a transplant trial for patients with multiple myeloma, as well as a trial testing reduced intensity conditioning trial for elderly AML patients; and the COG collaborated with the BMT CTN to enter patients on a trial comparing single vs. double cord blood transplant in children. More recently, the BMT CTN and the Alliance is collaborating on a trial to test ibrutinib during and after autologous HCT in lymphoma patients. Both through disease-specific working groups that consist of members of the Group transplant committees and the BMT CTN, and now with the establishment of the NCTN, further enhancement of cooperation through collaborative trials are expected for development and implementation of a national program in 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/