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Acute Graft Versus Host Disease clinical trials

View clinical trials related to Acute Graft Versus Host Disease.

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NCT ID: NCT05443425 Recruiting - Clinical trials for Hematopoietic and Lymphoid System Neoplasm

Leflunomide in Combination With Steroids for the Treatment of Acute Graft-versus-Host Disease After Donor Stem Cell Transplant for Hematologic Malignancies

Start date: June 16, 2023
Phase: Phase 1
Study type: Interventional

This phase I trial tests the safety and side effects of leflunomide in combination with steroids in treating patients with acute graft versus host disease who have undergone done stem cell transplant for blood cancers (hematologic malignancies). Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Leflunomide and steroids are immunosuppressive drugs that work in different ways to lower the body's immune response so that the new donor immune cells do not attack the body's normal cells. Giving leflunomide in combination with steroids may help treat acute graft versus host disease in patients after stem cell transplant for hematologic malignancies.

NCT ID: NCT05352269 Recruiting - Clinical trials for Acute-graft-versus-host Disease

Safety and Tolerability of FMT Capsules in Healthy Volunteers

Start date: April 21, 2022
Phase: Phase 1
Study type: Interventional

This is a two-part, randomized, double-blind, placebo-controlled, single center study to investigate the safety and tolerability of XBI-302 administered orally in healthy volunteers. The hypothesis of this study is that XBI-302 is safe and well tolerated with the proposed dosing regimens.

NCT ID: NCT05263999 Recruiting - Clinical trials for Graft Versus Host Disease

A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)

Start date: April 29, 2022
Phase: Phase 3
Study type: Interventional

This is a multi-center study to compare the efficacy 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

NCT ID: NCT05236062 Recruiting - Clinical trials for Graft Vs Host Disease

Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial

RESTART
Start date: April 14, 2022
Phase: N/A
Study type: Interventional

This study is about determining if an aerobic and resistance exercise intervention is feasible in patients diagnosed with acute or chronic GVHD (Graft-Versus-Host Disease) after having an allogeneic stem cell transplant. The names of the study interventions involved in this study are: - Aerobic and resistance exercise (A+R) - Home-based aerobic and resistance exercise program - Attention control (AC) - Home-based stretching program

NCT ID: NCT05149365 Recruiting - Clinical trials for Allogeneic Hematopoietic Stem Cell Transplantation

Sitagliptin for Prevention of aGVHD After Alternative Donor Transplantation

Start date: December 22, 2021
Phase: Phase 3
Study type: Interventional

Primary Objective: It is hypothesized that the efficacy of Sitagliptin would reduce the incidence of grade II-IV acute Graft Versus Host Disease (GVHD) by day +100 post-transplant in patients undergoing alternative donor (related haploid or unrelated donor ) allogeneic Hematopoietic Stem Cell Transplantation (HSCT) and receiving standard GVHD prophylaxis. Secondary Objectives The following descriptive secondary objectives will be studied: 1. Determine the tolerability and potential toxicity of sitagliptin in patients undergoing allogeneic HSCT. 2. Determine the cumulative incidence of grades II-IV acute GVHD by day +100. 3. To investigate the cumulative incidence of grades III-IV acute GVHD. 4. To investigate the engraftment kinetics of absolute neutrophil count and platelets. 5. To evaluate the incidence of Cytomegalovirus (CMV), Epstein-Barr virus (EBV) and other infections occurring during the 100 days post-transplant. 6. To study non-relapse mortality (NRM) at day +100, and 1 year post-transplant. 7. Determine the overall survival at 1 year post-transplant. 8. Determine the incidence of chronic GVHD. 9. Determine the cumulative incidence of relapse of the primary hematological malignancy.

NCT ID: NCT05123040 Recruiting - Clinical trials for Acute-graft-versus-host Disease

Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids

Start date: June 5, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This multi-center center phase I/II study to establish the lowest possible recommended phase 2 dose (RP2D) of corticosteroids in conjunction with ruxolitinib and uhCG/EGF (a novel combination) for high-risk aGVHD. This is a single arm study designed to determine the lowest dose of corticosteroids required (toxicity endpoint) without impairing GVHD complete response or partial response (CR/PR) at day 28 when given in conjunction with uhCG/EGF and ruxolitinib. After completion of the corticosteroid dose finding, the final dose will be carried forward into a two-stage phase II extension trial to confirm safety and make a preliminary determination of efficacy of this novel drug combination for high-risk aGVHD.

NCT ID: NCT05121142 Completed - Clinical trials for Chronic Graft-versus-host-disease

Study of Ruxolitinib for Acute and Chronic Graft Versus Host Disease

Start date: October 27, 2021
Phase: Phase 1
Study type: Interventional

While hematopoietic stem cell transplant (HSCT) is an effective therapy, graft versus host disease (GVHD) is the most significant complication after HSCT. Both acute GVHD and chronic GVHD are leading causes of non-relapse morbidity and mortality. Patients with solid organ transplants may participate in this study as well because these patients occasionally develop acute GVHD, which is biologically similar to acute GVHD after an HSCT. Acute graft versus host disease usually occurs within the first 100 days of transplant and can involve the skin, gut, or liver. Chronic graft versus host disease usually occurs after the first 100 days of transplant and can involve skin, eyes, mouth, joints, liver, intestines commonly. These two diseases are different, but both happen due to the imbalance of the donor immune system in the host. The purpose of this research is to learn more about ruxolitinib as a treatment for both acute and chronic GVHD. Specifically, the investigators would like to learn more about the pharmacokinetics (PK - the process of absorption, distribution, metabolism, and elimination from the body - meaning how the drug moves through the body) and the pharmacodynamics (PD - the body's biological response to the drug) of ruxolitinib.

NCT ID: NCT05078073 Recruiting - Clinical trials for Acute-graft-versus-host Disease

HBOT in the Treatment and Prevention of aGVHD

Start date: October 10, 2021
Phase: N/A
Study type: Interventional

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative therapeutic strategy for patients with hematopoietic malignancies. However, the therapeutic benefits and wider application of allo-HSCT are limited by acute graft-versus-host disease (aGVHD), the latter remains a major obstacle against long-term survival for this population. New aGVHD prophylactic and therapeutic strategies that are superior in efficacy, safety, cost-effectiveness, and less technically demanding are still in desperate need. Hyperbaric oxygen therapy (HBOT) has been confirmed as an effective and economical therapeutic modality for hemorrhagic cystitis (HC) whether induced by infection or acute graft-versus-host disease (aGVHD) for transplant recipients. However, little is known about its involvement in aGVHD. In this study, the investigators designed a randomized, controlled, and open clinical trial to confirm the safety and efficacy of HBOT on aGVHD in patient underwent allo-HSCT.

NCT ID: NCT04976699 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

CD24Fc 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: CD24Fc vs placebo with the standard GVHD prophylaxis of tacrolimus / methotrexate.

NCT ID: NCT04971551 Not yet recruiting - Clinical trials for Acute Graft-Versus-Host Disease

A Study of Jaktinib for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.

Start date: December 2024
Phase: Phase 2
Study type: Interventional

This is an single-arm, Phase II multi-center study. The purpose of this study is to assess the efficacy and safety of Jaktinib in subjects with Grades II to IV steroid-refractory acute graft-versus-host disease.