Biologic Specimen and Data Repository Information Coordinating Center

The BMT CTN-1102 study was designed to evaluate the relative benefits of reduced intensity conditioning allogeneic HCT compared to non-transplant therapies in older patients with higher-risk myelodysplastic syndrome.

BMT CTN 0604 examine the safety and effectiveness of a non-myeloablative stem cell transplant using umbilical cord blood as a treatment option for patients with leukemia or lymphoma and no suitable related donor.

BMT CTN 1101 compared the effectiveness of two new types of bone marrow transplants in people with leukemia or lymphoma: one that uses bone marrow donated from family members with only partially matched bone marrow (haplo-BM); and one that uses two partially matched cord blood units (dUCB).

BMT CTN 0802 explored the difference in response and survival rates for individuals with acute graft versus host disease who received mycophenolate mofetil plus corticosteroids versus corticosteroids alone.

The BMT CTN 1203 trial was initiated to evaluate three novel approaches for graft-versus-host disease prophylaxis compared to a contemporary control.

BMT CTN 0701 evaluated the effectiveness of reduced intensity conditioning in the procedure called non-myeloablative allogeneic blood stem cell transplant for people with relapsed follicular non-Hodgkin's lymphoma.

BMT CTN 0402 investigated if the combination of tacrolimus and sirolimus (Tac/Sir) was more effective than tacrolimus and methotrexate (Tac/Mtx) in preventing acute graft-versus-host disease and early mortality after allogeneic related donor hematopoietic cell transplantation.

The BMT CTN 1501 study was initiated to estimate the difference in day 28 complete response/partial response rates for sirolimus vs prednisone as initial treatment of patients with standard risk acute graft-versus-host disease.

BMT CTN 0102 compared progression-free survival of patients with multiple myeloma biologically assigned to receive autologous hematopoietic cell transplantation followed either a second auto HCT or by allogeneic transplantation. Patients within the tandem autologous transplantation arm were randomized to receive one year of maintenance therapy with thalidomide plus dexamethasone or observation.

The BMT CTN 0903 study assessed the feasibility and safety of allogeneic hematopoietic cell transplantation in HIV-infected patients. The primary endpoint was 100-day non-relapse mortality.

BMT CTN 0603 compared survivorship of recipients who received a bone marrow transplant, using the reduced intensity conditioning transplant technique, from a related and partially matched donor. This trial ran in parallel with BMT CTN 0604.

The purpose of the BMT CTN 1301 study was to compare chronic Graft-versus-Host Disease after hematopoietic cell transplant between two calcineurin inhibitor free interventions and a tacrolimus/methotrexate control in patients with HLA-matched donors.

BMT CTN 0201 compared survival rates of patients with hematologic cancers that received transplantation of granulocyte colony stimulating factor mobilized peripheral blood stem cells versus marrow from HLA-compatible unrelated donors.

BMT CTN 0301 was designed to determine the feasibility and toxicity of employing fludarabine-based conditioning to reduce transplant-related toxicity while maintaining (or ideally improving) engraftment in allogeneic donor marrow transplantation from matched and mismatched unrelated donors in patients with severe aplastic anemia.

The BMT CTN 1302 study was initiated to evaluate the efficacy of ixazomib maintenance therapy after reduced-intensity conditioning allogeneic stem-cell transplantation from HLA-matched donors in patients with high-risk multiple myeloma.

The BMT CTN 1502 study was a prospective, multicenter phase II study with patients receiving haploidentical transplantation for severe aplastic anemia. The study resulted in excellent overall survival with minimal GVHD in patients who were refractory or relapsed after immunosuppressive therapy.

The BMT CTN 1202 study aimed to establish accurate and reproducible methods to diagnose, grade, and report graft-versus-host disease in patients post-hematopoietic cell transplantation.

BMT-CTN 0801 was a phase II/III trial designed to compare the responses of patients with graft-versus-host disease who received sirolimus/calcineurin inhibitor plus prednisone versus sirolimus plus prednisone.

BMT CTN 0902 was designed to determine whether self-directed exercise and/or stress management improves self-reported physical and mental functioning compared to standard care in patients following autologous or allogeneic hematopoietic cell transplantation.

BMT CTN 0403 was designed to determine the response and survival rate of patients with idiopathic pneumonia syndrome post allogeneic hematopoietic cell transplantation, following treatment with etanercept plus corticosteroids compared to placebo plus corticosteroids.

BMT CTN-0901 was a phase III randomized clinical trial designed to determine if reduced-intensity conditioning would result in improved overall survival given the lower treatment-related mortality compared with myeloablative conditioning in patients with myelodysplastic syndrome and acute myeloid leukemia.

BMT CTN-1703 was a Phase 3 study comparing two graft-vs.-host-disease prophylaxis strategies in patients undergoing hematopoietic stem cell transplantation after reduced-intensity conditioning. This study was a follow up to BMT CTN-1203.

The BMT CTN-0702 study was initiated to compare tandem autologous hematopoietic cell transplantation (AHCT) followed by lenalidomide maintenance, AHCT plus four cycles of lenalidomide, bortezomib, and dexamethasone (RVD) followed by lenalidomide, and AHCT and lenalidomide only in improving progression free survival for patients with active multiple myeloma.

BMT CTN 0101 was designed as a Phase III study of fluconazole versus voriconazole for the prevention of fungal infections in allogeneic transplant recipients.

BMT CTN 0803 was designed to evaluate the effectiveness of autologous hematopoietic cell transplantation for HIV positive patients with chemotherapy-sensitive aggressive B cell lymphoma or Hodgkin's HIV-Related Lymphoma who received carmustine, etoposide, cytarabine, and melphalan (BEAM) as the pre-transplant conditioning regimen.

BMT CTN-0501 was designed to determine whether two partially HLA-matched umbilical cord-blood (UCB) units were better than one at improving one-year survival in pediatric patients with high risk leukemia or myelodysplasia.

The BMT CTN-1401 study was initiated to compare response at one year post-transplant between participants receiving dendritic cell/myeloma vaccine along with granulocyte macrophage colony-stimulating factor (GM-CSF) and lenalidomide maintenance therapy to those receiving lenalidomide maintenance therapy with or without GM-CSF.

BMT CTN 0302 evaluated the effectiveness of each of four new drugs (etanercept, mycophenolate mofetil (MMF), denileukin diftitox (denileukin), and pentostatin) in combination with corticosteroids, as initial therapy for acute graft-versus-host disease.

BMT CTN 0401 compared progression-free survival after autologous hematopoietic stem cell transplantation for chemotherapy-sensitive diffuse large B-cell lymphoma using Rituxan/BEAM versus Bexxar/BEAM for pre-transplant conditioning.

BMT CTN 1204 tested the safety and efficacy of intermediate timing (day -14) of alemtuzumab as part of a reduced-intensity conditioning protocol in subjects with hemophagocytic lymphohistiocytosis and other primary immunodeficiencies.

BMT CTN 0601 was a phase II, single arm, multi-center trial designed to estimate the efficacy and toxicity of unrelated donor HCT using a reduced-intensity conditioning regimen in pediatric patients with Sickle Cell Disease and high-risk features.

ROC-PROPPR assessed whether there is a reduction in massive transfusion complication and mortality rates by comparing subjects who received plasma, platelets, and red blood cells in a 1:1:2 ratio with those who received a more traditional transfusion ratio of 1:1:1.

REDS-RADAR is a linked donor-recipient collection whose purpose was to determine if newly identified or emerging pathogens can be transmitted by transfusion, and to build a more contemporary donor-recipient repository.

REDS-GLPR specimens were collected to provide researchers with a large representative sample of blood donors with linked demographic data and donation test results. Donor screening and testing included anti-HIV, anti-HCV, anti-HTLV, HBsAg and anti-HBc, serologic testing for syphilis and testing for ALT levels.

The purpose of REDS I was to evaluate the human retroviruses HIV-1, HIV-2, HTLV-I and HTLV-II in blood donors from U.S. areas with varying risk for HIV. The HTLV Cohort includes HTLV-I infected, HTLV-II infected and uninfected blood donors, all of whom were HIV type 1 seronegative at enrollment.

REDS II-CORE aimed to build a well-developed blood donation database and deferral database to provide insight on critical issues within the blood banking community. The databases offer a look at the demographic characteristics of donors including racial/ethnic differences, donation patterns of first-time and repeat donors and deferral trends.

REDS II-RISE was designed to evaluate the effects of blood donation intensity on iron and hemoglobin status, assess factors that could modify that relationship and provide data to help formulate optimal whole blood donation frequency.

REDS II-LAPS was a two phase study. The LAPS-I study was designed to measure the prevalence of HLA and neutrophil antibodies in blood donors with or without a history of pregnancy or blood transfusion and to develop a repository of blood samples from well characterized blood donors whose detailed pregnancy and transfusion histories are known. The LAPS-II study was designed to evaluate a primary endpoint of combined incidence of transfusion-related acute lung injury (TRALI) and possible TRALI in study recipients of at least one HLA antibody-positive high-plasma-volume component received from a LAPS-I donor versus control recipients of at least one HLA antibody-negative high-plasma-volume component.

REDS II-MS conducted a genetic analysis of incident and prevalent strains of HIV, HCV and HBV by testing blood specimens from positive donors. Infected donors were identified among approximately 34 million U.S. blood donations based on screening and confirmatory tests for HIV and HCV nucleic acid testing, HIV and HCV antibody, HBsAg and anti-HBV core antibody.

REDS II-Chagas was a retrospective cohort study meant to characterize the natural history of clinical Chagas disease, measure disease penetrance, and determine prognostic factors of Chagas cardiomyopathy among asymptomatic Trypanosoma cruzi-infected persons identified 10 years prior to the study.

The REDS-III US Zika Natural History Study sought to investigate the dynamics of viral and serological markers and clinical symptomatology following acute Zika virus infection in blood donors, and collect comprehensive data on viral persistence in blood compartments and body fluids in dengue virus-exposed and -naïve donors.

REDS-III aimed to ensure safe and effective blood banking and transfusion medicine practices through a comprehensive, multifaceted strategy involving basic, translational, and clinical research to improve the benefits of transfusion while reducing its risks.

The TMH-RECESS study was initiated to compare clinical outcomes after cardiac surgery in patients who received transfused red cells stored for 10 days or less or for 21 days or more.

The TMH-RING study was initiated to compare the safety and effectiveness of granulocyte transfusions along with standard care versus standard care alone in improving survival rates in people with a bacterial or fungal infection during neutropenia.