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Graft vs Host Disease clinical trials

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NCT ID: NCT06133192 Not yet recruiting - Clinical trials for Graft Vs Host Disease

Steroids Versus ECP and Steroids as First-line Treatment of Grade II Acute GVHD

COPAVEHDI
Start date: January 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to compare as a first line of grade II skin acute GVHD sconventional treatment with steroids alone to a combination of steroids and extracoporeal photopheresis (ECP) The primary end point will compare Freedom from treatment failure at 6 months from randomization as defined by meeting all the following 4 conditions: - to be alive - without relapse of the hematological disease - without having required a new line of treatment for acute GVHD - without initiating a systemic treatment for chronic GVHD.

NCT ID: NCT06128070 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia

Ruxolitinib With Tacrolimus and Methotrexate for the Prevention of Graft Versus Host Disease in Pediatric and Young Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplant for Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome

Start date: June 14, 2024
Phase: Phase 2
Study type: Interventional

This phase II trial tests how well ruxolitinib with tacrolimus and methotrexate work to prevent the development of graft versus host disease in pediatric and young adult patients undergoing allogeneic hematopoietic cell transplant for acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Ruxolitinib is a type of medication called a kinase inhibitor. It works by blocking the signals of cells that cause inflammation and cell proliferation, which may help prevent graft versus host disease (GVHD). Tacrolimus is a drug used to help reduce the risk of rejection by the body of organ and bone marrow transplants by suppressing the immune system. Methotrexate stops cells from making DNA, may kill cancer cells, and also suppress the immune system, which may reduce the risk of GVHD. Giving ruxolitinib with tacrolimus and methotrexate may prevent GVHD in pediatric and young adults undergoing allogeneic hematopoietic cell transplants.

NCT ID: NCT06000982 Not yet recruiting - GVHD Clinical Trials

Comparison of Different Dose of Post-transplantation Cyclophosphamide as Graft Versus Host Disease Prophylaxis

Start date: October 1, 2023
Phase: Phase 3
Study type: Interventional

Post-transplantation cyclophosphamide (PTCY) is considered as major graft versus host disease (GVHD) prophylaxis. In our previous study, the investigators demonstrated that the standard dose PTCY of 50mg/kg with tacrolimus and post-engrafted low-dose anti-thymoglobulin (ATG) achieved low incidence of acute GVHD. More recently, it has been shown that reduced dose of PTCY of 40mg/kg is considered with similar efficacy as GVHD prophylaxis, In this study, a multi-center randomized comparison is planned to evaluate the clinical outcome of GVHD prophylaxis of PTCy 40 versus 50.

NCT ID: NCT05969743 Not yet recruiting - Clinical trials for Graft-versus-host-disease

Letermovir Prophylaxis for Cytomegalovirus (CMV) in Patients With Graft-versus-host Disease

Start date: October 1, 2023
Phase: Phase 2
Study type: Interventional

Explore the tolerability and efficacy of letermovir in the prevention of CMV reactivation in patients with acute and chronic graft-versus-host disease (GVHD) beyond day 100.

NCT ID: NCT05968170 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia

TCRαβ/CD19 Depletion of Stem Cell Grafts for Transplant

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

The CliniMACS® device is FDA-approved only for one indication (CD34+ selection). Additional use of this device outside of this indication requires the use of feasibility studies. Children, adolescents and young adults with malignant and non-malignant conditions undergoing hematopoietic stem cell transplants will have stem cells selected using alpha-beta+/CD19+ cell depletion. This is a single arm feasibility study using this processing of peripheral stem cells with alternative donor sources (haploidentical, mismatched, matched unrelated) to determine efficacy as seen by engraftment and graft-versus-host disease (GVHD).

NCT ID: NCT05333029 Not yet recruiting - Clinical trials for Graft Versus Host Disease

Extracorporeal Photopheresis and Mesenchymal Stem Cell Infusion for GVHD

Start date: October 1, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to see if two treatments (extracorporeal photopheresis and Mesenchymal Stromal Cell (MSC) infusion, can be given safely together, and if they improve the symptoms of a Graft versus Host Disease (GvHD), a complication that can occur in people who undergo stem cell transplant.

NCT ID: NCT05276076 Not yet recruiting - Clinical trials for Graft Versus Host Disease

A Prospective, Open Label, Dose-escalation, SAD/MAD, Multicenter, 24weeks, Phase I/IIa Clinical Trial to Evaluate the Safety, Tolerability and Pharmacodynamics of Investigational Product (VM-001) in Patients With Graft-versus-host Disease(GvHD)

Start date: November 20, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The present study is multi center, phase I/IIa clinical trial to evaluate the safety and pharmacodynamics of investigational Product (VM-001) in patients with graft-versus-host disease(GvHD). A total of 12 subjects (Part 1 SAD[3 cohort(2 subjects/cohort)], Part 2 MAD[2 cohort(3subjects/cohort)]) are recruited.

NCT ID: NCT05158608 Not yet recruiting - Clinical trials for Graft Versus Host Disease

Comparison of PT-Cy at a Dose of 25 mg/kg/Day and PT-Cy at a Dose of 50 mg/kg/Day in GVHD Prophylaxis

CY25
Start date: January 1, 2022
Phase: Phase 3
Study type: Interventional

This is a two arm open label phase III clinical trial. Adult patients with hematological malignancies undergoing allogeneic HSCT from any donor are eligible for the study if they meet the standard criteria defined in the investigator's institutional standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Patients will receive reduced-intensity conditioning regimen of fludarabine, busulfan (treosulfan). Patients will receive PTCy at different dose (25 mg/kg/day vs 50 mg/kg/day on day +3,+4 in combination with calcineurin inhibitors and mofetil mycophenolate) as GvHD prophylaxis.

NCT ID: NCT05067595 Not yet recruiting - Clinical trials for Intestinal Graft Versus Host Disease

Fecal Microbiota Transplant and Dietary Fiber Supplementation for the Treatment of Gut Graft Versus Host Disease

Start date: June 20, 2024
Phase: Phase 1
Study type: Interventional

This phase I trial studies how well fecal microbiota transplant and dietary fiber supplementation work in treating patients with gut graft versus host disease. Fecal microbiota transplant entails inoculating donor stool into a recipient's gastrointestinal tract. Changing the gut microbiome by fecal microbiota transplant and fiber supplementation may help treat gut graft versus host disease.

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.