Phase 2 N=30 Randomized Trial for Mixed Acute Rejection
Graft Rejection
Primary: Number of Patients in Each Group With Any of the Following: Rejection Reversal or Recurrent Rejection — 0; 0; 0; 2 participants
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Phase 2 N=21 Tacrolimus and Thymoglobulin, as GvHD Prophylaxis in Patients Undergoing Related Donor HCT
Hematological Malignancies
Primary: Incidence of Acute GVHD — 45.0 percentage of participants
Phase 2 N=180 Treatment for Acute Graft-Versus-Host Disease (BMT CTN 0302)
Graft vs Host Disease · Immune System Disorders
Primary: Number of Complete Response (CR) at Day 28 of Therapy — 12; 27; 25; 16 participants
Phase 3 N=236 Acute Graft-versus-Host Disease Treatment (BMT CTN 0802)
Graft-versus-Host Disease · Immune System Disorders
Primary: GVHD-free Survival — 60; 69; 59; 47 participants
Phase 2 N=46 T Cell Depletion for Recipients of HLA Haploidentical Related Donor Stem Cell Grafts
Acute Lymphoblastic Leukemia · Non Hodgkins Lymphoma · Myelodysplastic Syndrome
Primary: Engraftment Rate After Transplant — 100; 100 percentage of participants
N/A N=15 The Effect of Rituximab on the Development of Anti-Donor Antibodies
Renal Transplant Rejection
Primary: Change in Biopsy Cell Densities From Baseline to Follow-up — -164; -122.5; -129.4; 30.4 cells/mm^3 — p=0.25
Phase 2 N=279 Novel Approaches for Graft-versus-Host Disease Prevention Compared to Contemporary Controls (BMT CTN 1203)
Acute Leukemia · Chronic Myelogenous Leukemia · Myelodysplasia
Primary: Percentage of Participants With GVHD/Relapse or Progression-free Survival (GRFS) — 35.5; 27.2; 44.1 percentage of participants
Phase 2 N=36 Pentostatin and Lymphocyte Infusion in Preventing Graft Rejection in Patients Who Have Undergone Donor Stem Cell Transplant
Acute Lymphoblastic Leukemia · Acute Myeloid Leukemia · Chronic Lymphocytic Leukemia
Primary: Percentage Patients With an Increase of at Least 10 Percentage Points in Donor T-cell Chimerism — 60; 30; 33.3 percentage of participants
Phase 4 N=30 Cytokines Evaluation in Early Calcineurin Inhibitors Withdrawn on Renal Transplant
Renal Transplant Rejection · Immunosuppression
Primary: Cytokines Evaluation — 380; 893; 763; 147 MFI — p=<0.05
N/A N=20 Thymoglobulin and Total Lymphoid Irradiation for Hematologic Malignancies
Lymphoma · Leukemia
Primary: Composite Success Rate — 100; 75; 84 Percentage of participants
Phase 2 N=30 Tacrolimus, Sirolimus and Ustekinumab vs. Tacrolimus and Sirolimus for the Prevention of Acute Graft-Versus-Host Disease
Graft vs. Host Disease
Primary: T Regulatory Cell (Treg)/Total Cluster of Differentiation 4 (CD4)+ Ratio — 13; 11 ratio
Phase 2 N=5 Effectiveness of the Investigational Drug Campath-1H in Preventing Rejection of Transplanted Kidneys
Graft Rejection · Kidney Disease
Primary: Number of Patients With Renal Allograft Rejection — 5 participant
Phase 3 N=164 Low-Dose Prednisone or Methylprednisolone in Treating Patients With Newly Diagnosed Acute Graft-versus-Host Disease
Graft Versus Host Disease · Recurrent Adult Acute Lymphoblastic Leukemia
Primary: Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment — 22.2; 27.1; 38.4; 41.3 milligrams per kilogram — p=0.08
N/A N=96 Angiotensin Converting Enzyme (ACE) Inhibition and Cardiac Allograft Vasculopathy
Cardiac Allograft Vasculopathy
Primary: Cardiac Allograft Vasculopathy(CAV) Defined as Change in IVUS-assessed Plaque Volume From Baseline to One Year — 3.39; 3.65 mm3/mm
Phase 3 N=194 Progression of Renal Interstitial Fibrosis / Tubular Atrophy (IF/TA) According to Epithelial-mesenchymal Transition (EMT) and Immunosuppressive Regimen (Everolimus Based Versus CNI Based) in de Novo Renal Transplant Recipients
Renal Interstitial Fibrosis
Primary: Number of Participants With Progression of Renal Graft Fibrosis (Primary Comparison - ITT Population — 26; 31; 12; 16 Participants
Phase 2 N=40 Belatacept Post Depletional Repopulation to Facilitate Tolerance
Organ Transplantation
Primary: Number of Patients Successfully Withdrawn From Oral Immunosuppression — 12; 7 Participants
Phase 3 N=36 The De-novo Use of Eculizumab in Presensitized Patients Receiving Cardiac Transplantation
Antibody-mediated Rejection · Hyperacute Rejection of Cardiac Transplant · Left Ventricular Dysfunction
Primary: Number of Participants of Pathologic Antibody-Mediated Rejection and Left Ventricular Dysfunction — 4 Participants
Phase 2 N=20 Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts in Preventing GVHD in Children
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive · Acute Biphenotypic Leukemia · Acute Leukemia of Ambiguous Lineage
Primary: Graft Failure — 0; 1 Participants
Phase 2 N=21 Cyclophosphamide and Anti-thymocyte Globulin Followed By Methotrexate and Cyclosporine in Preventing Chronic Graft-Versus-Host Disease in Patients With Severe Aplastic Anemia Undergoing Donor Bone Marrow Transplant
Aplastic Anemia
Primary: Incidence of Chronic GVHD — 5 number participants with chronic GVHD
Phase 3 N=34 The Use of Etanercept Enbrel as Sole Treatment for Grade I Acute Graft Versus Host Disease
Acute Graft Versus Host Disease
Primary: The Percentage of Patients Who Progress Within 28 Days of Initiation of Etanercept Treatment — 29 percentage of patients
Phase 2 N=33 Tocilizumab for Renal Graft Inflammation
Late Complication From Kidney Transplant
Primary: Change in Inflammation on Renal Allograft Biopsy From Baseline to 6 Months — 3; 10 Participants — p=0.033
Phase 2 N=81 Photopheresis for the Treatment of Acute Graft Versus Host Disease
Graft Versus Host Disease
Primary: Day 56 Treatment Success — 57; 72; 43; 47 percentage of participants
N/A N=11 TCR-α/β and CD19 Depleted Stem Cell Grafts From Haplo Donors for HSCT in Relapsed Lymphoma
Lymphoma
Primary: Number of Participants With Absolute Neutrophil Count >= 500/Mcl for 3 Consecutive Measurements on Different Days and Platelet Count > 20,000/mm^3 With no Platelet…
Phase 2 N=76 Multicenter Study Of Natalizumab Plus Standard Steroid Treatment For High Risk Acute Graft-Versus-Host Disease
Acute Graft Versus Host Disease
Primary: Number of Participants With Complete Response (CR) — 34 Participants
Phase 2 N=303 Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Anti-Thymocyte Globulin (ATG) for Older Patients With Hematologic Malignancies
Blood Cancer · Leukemia
Primary: Acute Graft vs Host Disease (GvHD) — 2.7 percentage of participants
Phase 2 N=77 Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts From HLA-Matched Related and Unrelated Donors in Preventing GVHD
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive · Acute Biphenotypic Leukemia · Acute Leukemia of Ambiguous Lineage
Primary: Chronic GVHD — 17; 20; 14; 17 Participants
Phase 2 N=46 Cyclophosphamide, Abatacept, and Tacrolimus for GvHD Prevention
Graft-versus-host Disease
Primary: Percentage of Participants With Grade II-IV Acute GvHD by Day +120 — 17.4 Percentage of participants
Phase 2 N=10 Clazakizumab for Chronic and Active Antibody Mediated Rejection Post-Kidney Transplant
Antibody-mediated Rejection · Kidney Transplant; Complications · Transplant Glomerulopathy
Primary: Number of Participants With Donor Specific Antibody (DSA) Elimination or Reduction Based on Luminex HLA Testing — 7 Participants
Phase 2 N=48 Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplant
Chronic Myeloproliferative Disorders · Leukemia · Lymphoma
Primary: Incidence of Acute Graft-versus-host Disease (GVHD) — 44.7 percentage of participants
N/A N=4 Partially Matched Stem Cell Transplantation for Patients With Refractory Severe Aplastic Anemia or Refractory Cytopenias
Anemia, Aplastic · Amegakaryocytic Thrombocytopenia · Diamond-Blackfan Anemia
Primary: Treatment Failures