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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Itolizumab in Combination With Corticosteroids for the Initial Treatment of Acute Graft Versus Host Disease
Rochester, Minn.
The purpose of this study is to compare the effectiveness and safety of itolizumab versus placebo as first-line therapy for subjects with Grade III-IV aGVHD or Grade II with LGI involvement, in combination with corticosteroids.
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ACCESS: A Multi-Center, Phase II Trial of HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation with Post-Transplantation Cyclophosphamide for Patients with Hematologic Malignancies (ACCESS)
Rochester, Minn.
The purpose of this study is to look at the effectiveness of using a study drug called cyclophosphamide (PTCy) to prevent graft versus host disease (GVHD) in individuals who have received a blood stem cell or bone marrow transplant from a donor who is not a perfect match. There are three study groups: one which is for adults who will receive a typical conditioning regiment prior to their peripheral blood stem cell (PBSC) transplant, one for adults which will receive a not as intense conditioning regiment and one for children who will receive a bone marrow transplant.
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Mount Sinai Acute Graft-versus-Host Disease International Consortium (MAGIC): A Database and Biorepository (MAGIC)
Rochester, Minn.
The objectives of this study are to prospectively collect hematopoietic stem cell transplantation (HCT) data, complications and outcomes pertinent to graft-versus-host disease from allogeneic HCT patients for future analysis, and to prospectively collect and store blood for future analysis from allogeneic HCT patients.
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Radiation and Alkylator-free Hematopoietic Cell Transplantation for Bone Marrow Failure Due to Dyskeratosis Congenita/Telomere Disease
Rochester, Minn.
The purpose of this study is to test whether a regimen that avoids DNA compounds and radiation can permit successful bone marrow transplantation (BMT) without compromising survival in patients with DC.
Closed for Enrollment
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A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other Indications
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.
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A Multi-center Phase II Trial Randomizing Novel Approaches for Graft-versus-Host Disease Prevention Compared to Contemporary Controls (BMT CTN #1203; Progress I)
Rochester, Minn.
Acute Graft-versus-Host-Disease (GVHD) is an important cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation (HSCT). This study aims to determine if any of three new GVHD prophylaxis approaches improves the rate of GVHD and relapse free survival at one year after transplant compared to the current standard prophylaxis regimen.
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A Multicenter Safety Study of Unlicensed, Investigational Cryopreserved Cord Blood Units Manufactured by the National Cord Blood Program and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients
Rochester, Minn.
The purpose of this study is to evaluate the safety of using unlicensed cord blood units from the National Cord Blood Program in unrelated patients needing stem cell transplants, by carefully documenting all infusion-related problems.
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A Multi-Center, Phase III, Randomized Trial of Reduced Intensity (RIC) Conditioning and Transplantation of Double Unrelated Umbilical Cord Blood (dUCB) Versus HLA-Haploidentical Related Bone Marrow (Haplo-BM) for Patients With Hematologic Malignancies (BMT CTN #1101)
Rochester, Minn.
Hematopoietic cell transplants (HCT) are one treatment option for people with leukemia or lymphoma. Family members, unrelated donors or banked umbilical cordblood units with similar tissue type can be used for HCT. This study will compare 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; and, one that uses two partially matched cord blood units.
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A Multicenter, Pivotal Phase 3 Study of Iomab-B Prior to Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia (SIERRA)
Rochester, Minn.,
Jacksonville, Fla.
The primary objective of this study is to demonstrate the efficacy of Iomab-B, in conjunction with a Reduced Intensity Conditioning (RIC) regimen and protocol-specified allogeneic hematopoietic stem cell transplant (HCT), versus Conventional Care.
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A Phase Ib, Open-Label, Randomized, Dose-Finding, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of GDC-8264 in Combination with Standard of Care in the Treatment of Acute Graft-Versus-Host Disease in Patients who have undergone Allogeneic Hematopoietic Stem Cell Transplantation
Rochester, Minn.
The purpose of this study is to identify an optimal dose for GDC-8264 for future studies, using all available safety, pharmacokinetic, and effectiveness data.
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A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Protective Efficacy and Safety of a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT) (HELIOS)
Rochester, Minn.
The purpose of the study is to determine if overall mortality is affected one year after a hematopoietic stem cell transplant (HCT) in patients given a vaccine to prevent cytomegalovirus (CMV). Safety of ASP0113 in subjects undergoing allogeneic HCT will also be evaluated.
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A Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation
Rochester, Minn.,
Jacksonville, Fla.
The primary purpose of this study is to compare 1 year graft-versus-host disease (GVHD)-free, graft relapse-free survival (GRFS) between the two GVHD prophylaxis regimens.
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A Randomized, Phase II, Multicenter, Open Label, Study Evaluating Sirolimus and Prednisone in Patients With Refined Minnesota Standard Risk, Ann Arbor 1/2 Confirmed Acute Graft-Versus-Host Disease (BMT CTN #1501)
Rochester, Minn.
The study is a Phase II randomized, open label, multicenter trial designed to identify whether sirolimus is a potential alternative to prednisone as an up-front treatment for patients with standard-risk acute GVHD defined according to clinical and biomarker-based risk stratification. This trial incorporates both a novel up front GVHD therapy (sirolimus) as well as a novel BMT CTN developed acute GVHD biomarker test.
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An Open-Label, Expanded Access Program of Ruxolitinib for the Treatment of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant
Rochester, Minn.
The purpose of this study is to provide ruxolitinib through an expanded access program in the United States for the treatment of graft-versus-host disease (GVHD) in patients who are ineligible or unable to participate in any actively enrolling Incyte-sponsored clinical studies for ruxolitinib in the treatment of GVHD.
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BMT CTN 1704: Composite Health Assessment Risk Model for Older Adults: Applying Pre-transplant Comorbidity, Geriatric Assessment and Biomarkers to Predict Non-Relapse Mortality After Allogeneic Transplant (CHARM)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to determine the set of assessments and biomarkers that could together constitute a robust and valid composite health risk model for accurate personalized estimation of one year NRM.
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Clinical Transplant-Related Long-term Outcomes of Alternative Donor Allogeneic Transplantation (CTRL-ALT-D) (CTRL-ALT-D)
Rochester, Minn.
The primary purpose of this study is to estimate and compare overall survival between the two arms: patients who are Very Likely to find a Matched Unrelated Donor (MUD) versus those who are Very Unlikely to find a MUD.
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Defibrotide for patients with hepatic veno-occlusive disease (VOD): A treatment IND Study (Under 21 CFR 312.34)
Rochester, Minn.
Single arm, open-label study to provide Defibrotide to patients diagnosed with VOD. Defibrotide is no longer available though the Emergency Use IND mechanism (also known as compassionate use, or single patient named use). This protocol is the only mechanism by which Defibrotide can be made available to patients in the U.S.
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GRAVITAS-301: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease
Rochester, Minn.
The purpose of this study is to evaluate itacitinib or placebo in combination with corticosteroids as first-line treatment of participants with Grade II to IV acute graft-versus-host disease (aGVHD).
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Itacitinib Monotherapy for Low Risk Graft-vs-Host Disease
Rochester, Minn.
The purpose of this study is to test whether patients with low risk Great-vs-Host Disease (GVHD) can be successfully treated without steroids. Patients who participate with this study will be treated with itacitinib instead of steroids. Itacitinib is an experimental drug with an excellent safety record and appears to have activity as a GVHD treatment. A new blood test can identify patients whose GVHD is most likely to respond to well to treatment (low risk GVHD).
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Michigan Acute Graft-Versus-Host Disease International Consortium (MAGIC): A Database and Biorepository (MAGIC)
Rochester, Minn.
Samples of blood and urine will be analyzed for biomarkers to check their predictivity of Graft-versus-Host Disease (GVHD) outcomes.
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Phase II Multicenter Study of Natalizumab plus Standard Steroid Treatment for High Risk Acute Graft-Versus-Host Disease
Rochester, Minn.
The purpose of this study is to assess the safety and effectiveness of combining the study drug Natalizumab (Tysabri®) with the standard use of steroid treatment, as a new treatment for acute graft versus host disease (acute GVHD). GVHD is the most common serious complication, after bone marrow transplant. GVHD occurs when the donor cells (the graft), treat the recipient's body as "foreign" and attack the cells in the recipient's body. During this immune system response, donor cells damage body tissues, such as the skin, liver, stomach, and/or intestines. Acute GVHD can be severe and potentially fatal to the transplant recipient.
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Prospective Multi-Center Cohort for the Evaluation of Biomarkers Predicting Risk of Complications and Mortality Following Allogeneic HCT (BMT CTN #1202)
Rochester, Minn.
The goal of this protocol is to establish a cohort of 1500 biologic samples collected prospectively from patients treated in BMT CTN centers that will be a shared bio specimen resource for conducting future allogeneic hematopoietic stem cell transplantation (HCT) correlative studies.
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Randomized Study of Individualized Care Plans for Hematopoietic Cell Transplant Survivors
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
This randomized study will compare a personalized Survivorship Care Plan (SCP) template with usual care (no SCP). The investigators hypothesize that the personalized SCP that incorporates patient specific treatment exposures and provides a framework for long term followup based on those exposures and subsequent risks for late complications will enhance patient survivorship confidence in knowledge, increase adherence to recommended healthcare, improve health behaviors and reduce HCT-related emotional distress.
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SER-155-001 A Phase 1b Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of SER-155 in Adults Undergoing Hematopoietic Stem Cell Transplantation to Reduce the Risk of Infection and Graft vs. Host Disease
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and effectiveness of SER-155 in adults undergoing hematopoietic stem cell transplantation to reduce the risk of infection and graft vs. host disease.
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