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Graft vs Host Disease clinical trials

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NCT ID: NCT04167514 Active, not recruiting - Clinical trials for Graft Versus Host Disease (GVHD)

Treatment of GVHD in Hematopoietic Stem Cell Transplant (HSCT) Recipients Using AAT Plus Corticosteroids (CS) Compared With Corticosteroids Alone (BMT CTN 1705)

Start date: January 9, 2020
Phase: Phase 3
Study type: Interventional

Study CSL964_5001 will investigate the efficacy of AAT with corticosteroids compared with corticosteroids alone as first line therapy for patients with high-risk acute GVHD

NCT ID: NCT04144036 Recruiting - Clinical trials for Graft-versus-host Disease

Neihulizumab for Standard-Risk Acute Graft Versus Host Disease (GVHD)

Start date: December 14, 2020
Phase: Phase 1
Study type: Interventional

This is a single-center Phase I study to determine the maximum tolerated dose and safety of Neihulizumab for the treatment of Minnesota standard-risk aGVHD. Patients undergoing allogeneic transplant with either a myeloablative or non-myeloablative conditioning regimen, and recipients of all donor sources will be enrolled to this trial.

NCT ID: NCT04139577 Completed - Clinical trials for Hematopoietic Cell Transplantation

FMT In High-Risk Acute GVHD After ALLO HCT

Start date: June 18, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of Fecal Microbiota Transplant (FMT) treatment in high-risk acute graft-versus-host disease (GVHD). This research study involves an experimental intervention called FMT.

NCT ID: NCT04131738 Completed - Clinical trials for Graft Vs Host Disease

Baricitinib for the Prophylaxis of Graft-Versus-Host Disease After Peripheral Blood Hematopoietic Cell Transplantation

Start date: April 7, 2020
Phase: Phase 1
Study type: Interventional

In this trial, the investigators will begin to explore the possibility that, as in mice, JAK1/2 inhibition with hematopoietic cell transplantation (HCT) may mitigate graft-versus-host-disease (GVHD) while retaining engraftment and Graft-versus-Leukemia (GVL). Both preclinical and clinical data suggest that inhibition of IFNy and IL-6, directly and using downstream JAK Inhibitors, may be an effective strategy to decrease toxicities and improve disease control for patients undergoing Allogeneic HSCT. Baricitinib, as a JAK1/2 inhibitor, has shown superiority to other JAK inhibitors in preclinical GVHD models. The purpose of this phase I clinical trial is to determine the safety of baricitinib with HSCT measured by the effect on engraftment and grade III-IV acute graft-versus-host-disease (aGVHD).

NCT ID: NCT04128319 Terminated - Clinical trials for Steroid-Refractory Acute Graft Versus Host Disease

T-Guard as Treatment for Steroid Refractory Acute GVHD (BMT CTN 1802)

1802
Start date: November 21, 2019
Phase: Phase 3
Study type: Interventional

The study is designed as an open-label, single arm Phase III, multicenter trial to evaluate the efficacy and safety of T-Guard treatment in patients with Steroid-Refractory acute Graft versus Host Disease (SR-aGVHD).

NCT ID: NCT04127721 Withdrawn - Clinical trials for Hematopoietic and Lymphoid Cell Neoplasm

Itacitinib for the Prevention of Graft Versus Host Disease in Patients Undergoing Donor Stem Cell Transplantation

Start date: September 22, 2020
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well itacitinib works in preventing graft versus host disease in patients with blood disorders undergoing donor stem cell transplantation. A donor transplantation uses blood-making cells from a family member or unrelated donor to remove and replace abnormal blood cells. Graft versus host disease is a reaction of the donor's immune cells against the patient's body. Itacitinib plus standard treatment may help prevent graft versus host disease in patients who have received a donor stem cell transplantation.

NCT ID: NCT04112810 Active, not recruiting - Clinical trials for Hematologic Malignancies

Tildrakizumab for Prevention of Acute Graft-Versus-Host Disease

Start date: March 1, 2020
Phase: Phase 2
Study type: Interventional

This is a phase 2 open-label trial designed to evaluate the efficacy of tildrakizumab in improving graft-versus-host disease (GVHD)-free relapse-free survival after myeloablative allogeneic hematopoietic cell transplantation (alloHCT) for hematologic malignancy.

NCT ID: NCT04111497 Terminated - Clinical trials for Chronic Graft Versus Host Disease

Glasdegib for Chronic Graft-Versus-Host Disease

Start date: December 3, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial studies whether glasdegib is helpful in treating sclerosis associated with chronic graft-versus-host disease. It will also investigate the safety of glasdegib in treating patients with chronic graft-versus-host disease.

NCT ID: NCT04095858 Terminated - Clinical trials for Acute Myeloid Leukemia

Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft Versus Host Disease (GVHD) Following Myeloablative Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-005)

CATHY
Start date: January 5, 2021
Phase: Phase 3
Study type: Interventional

The study compares two acute graft-versus-host disease (aGVHD) prophylaxis regimens: efprezimod alfa vs placebo with the standard GVHD prophylaxis of tacrolimus / methotrexate. The study compares two acute graft-versus-host disease (aGVHD) prophylaxis regimens: efprezimod alfa/tacrolimus / methotrexate (efprezimod alfa/Tac/MTX) versus placebo/tacrolimus / methotrexate (placebo/Tac/MTX) in the setting of myeloablative conditioning (MAC), matched unrelated donor (MUD) allogeneic hematopoietic stem cell transplantation in participants with acute leukemia (AML/ALL) or myelodysplastic syndrome (MDS). The study agent, efprezimod alfa, will be administered through IV infusion on days -1, 14, and 28 at the dose of 480mg, 240 mg and 240mg, respectively. The placebo will be 100 ml normal saline intravenous (IV) solution.

NCT ID: NCT04070781 Terminated - Clinical trials for Graft Vs Host Disease

Itacitinib and Tocilizumab for Steroid Refractory Acute Graft Versus Host Disease

GVHD
Start date: January 20, 2020
Phase: Phase 1
Study type: Interventional

The study's primary objective is designed to assess the safety and tolerability, and determine the maximum tolerated dose (MTD) of both itacitinib and tocilizumab when given in combination to patients with steroid-refractory acute graft versus host disease (SR-aGVHD). The study's secondary objectives are to: - Estimate the day 28 response rate (ORR) [complete response (CR), very good partial response (VGPR), and partial response (PR)] of the combination of itacitinib and tocilizumab for the treatment of SR-aGVHD - Estimate the time to response and duration of response - Estimate the incidence of primary disease relapse while on study treatment - Estimate the incidence of infections including viral reactivation, bacterial infections and fungal infections while on study treatment - Estimate the progression-free survival (PFS), overall survival (OS), non-relapse mortality, GVHD-related mortality of study subjects - Estimate the proportion of patients who successfully discontinue steroids by 6 months and 12 months after therapy initiation