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
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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 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=20 Alpha 1 Anti-Trypsin (AAT) in Treating Patients With Acute Graft-Versus-Host Disease GVHD)
Graft-Versus-Host Disease (GVHD) Acute on Chronic
Primary: Number (Percentage) of Patients at Each Dosing Cohort Who Experience no Toxicity and in Whom Graft Versus Host Disease (GVHD) is Stable or Improved — 6; 2; 2 Participants
Phase 2 N=51 Tildrakizumab for Prevention of Acute Graft-Versus-Host Disease
Hematologic Malignancies
Primary: GVHD-free Relapse-Free Survival — 19.3 percentage of subjects
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
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=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 3 N=439 GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease
Graft-versus-host Disease (GVHD)
Primary: Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response Index — 74.0; 66.4 Percentage of Participants — p=0.0782
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
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 1 N=9 Detection of Graft Versus Host Disease With [18F]F-AraG
Graft Versus Host Disease
Primary: Distribution of Acute GVHD Grades (MAGIC Criteria) at Time of PET/CT Scan — 0; 2; 0; 0 Participants
Phase 2 N=49 RGI-2001 for the Prevention of Acute Graft-vs-Host Disease in Subjects Following Allogeneic Hematopoietic Stem Cell Transplantation
Graft Vs Host Disease · Graft-versus-host-disease · Acute-graft-versus-host Disease
Primary: Grades II-IV aGVHD — 11 Participants
Phase 2 N=22 Histone Deacetylase Inhibitor LBH589 in Addition to Corticosteroids in Patients With Acute Graft Versus Host Disease (GVHD)
Graft-Versus-Host Disease
Primary: Phase I: Maximum Tolerated Dose (MTD) in Milligrams — 5 MTD of oral LBH589 in milligrams
Phase 2 N=74 Graft-Versus-Host Disease (GVHD) Prophylaxis After Allogeneic Peripheral Blood Hematopoietic Cell Transplantation
Acute Graft Versus Host Disease
Primary: Percentage of Participants With Evidence of Acute Graft Versus Host Disease (aGVHD), Post Transplant — 43; 89 percentage of participants
Phase 3 N=343 Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus Host Disease (aGVHD) in Participants Undergoing Allogeneic Hematopoietic Stem Cell (Allo-HSCT) Transplantation
Hematopoietic Stem Cells
Primary: Intestinal aGvHD-Free Survival After Allo-HSCT by +180 Days — NA; NA days — p=<0.001
Phase 2 N=379 A Study of Tacrolimus/Methotrexate and Tocilizumab to Prevent Acute Graft-Versus-Host Disease (AGVD) After Allogeneic Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplantation
Primary: Number of Subjects Not Experiencing Grade II-IV Acute Graph Versus Host Disease (aGVHD) — 3; 18; 0 Participants
Phase 2 N=152 An Open-Label Study of Defibrotide for the Prevention of Acute Graft-versus-Host-Disease (AGvHD)
Graft-versus-host Disease · Acute-graft-versus-host Disease
Primary: Cumulative Incidence Percentage of Grade B to D Acute Graft Versus Host Disease (aGvHD) by Day +100 Post-Hematopoietic Stem Cell Transplant (HSCT) — 38.4; 47.1…
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=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=174 Graft-Versus-Host Disease Prophylaxis in Treating Patients With Hematologic Malignancies Undergoing Unrelated Donor Peripheral Blood Stem Cell Transplant
Acute Lymphoblastic Leukemia · Acute Myeloid Leukemia · Aggressive Non-Hodgkin Lymphoma
Primary: Number of Patients With Grades II-IV Acute GVHD — 39; 22; 3 Participants
Phase 2 N=30 A Proof of Concept Pilot Trial of Alpha-1-Antitrypsin for Pre-Emption Of Steroid-Refractory Acute GVHD
Graft-versus-host-disease · GVHD
Primary: Number of High Risk Patients Who Develop Steroid Refractory GVHD — 6 Participants
Phase 2 N=3 MLN9708 for the Prophylaxis of Chronic Graft-versus-host Disease in Patient Undergoing Allogeneic Transplantation
Allogeneic Hematopoietic Stem Cell Transplantation
Primary: Maximum-tolerated Dose of MLN9708. — 4 millligram
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=35 Bortezomib-based GVHD Prophylaxis After Allogeneic Transplant for Patients Without Matched Related Donors
Leukemia · Lymphoma · Myelodysplastic Syndrome
Primary: The Cumulative Incidence of Grade II-IV Acute GVHD up to Day 100 After Stem Cell Infusion — 32 Percentage of participants
Phase 2 N=44 Ofatumumab as Primary Therapy of Chronic Graft Versus Host Disease
Chronic Graft Versus Host Disease
Primary: Maximum Tolerated Dose of Ofatumumab — 1000 mg
Phase 3 N=151 Chronic Graft-versus-Host Disease Treatment (BMT CTN 0801)
Chronic GVHD
Primary: Proportion of Participants With Treatment Success — 33; 35; 33; 37 Participants — p=0.63
Phase 2 N=37 Sitagliptin for Prevention of Acute Graft Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
Graft vs Host Disease · Hematopoietic Stem Cell Transplantation
Primary: Percentage of Patients With Grade II-IV Acute GvHD by Day +100 Following Transplant — 94.4 percentage of participants
Phase 2 N=80 Safety & Efficacy of Atorvastatin for Prophylaxis of Acute Graft Versus Host Disease in Patients With Hematological Malignancies HLA- Donor Hematopoietic Stem Cell Transplantation
Acute Myelogenous Leukemia · Acute Lymphocytic Leukemia · Myelodysplastic Syndrome
Primary: Percentage of Participants With Grades II to IV aGVHD at Day +100 of Atorvastatin Administration — 30 percentage of patients
Phase 2 N=13 CC-4047 (Pomalidomide) for Graft vs. Host Disease
Graft vs Host Disease
Primary: Overall Response (Complete Response + Partial Response + Other) — 7; 2; 0; 0 participants