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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: NCT06444022 Not yet recruiting - Clinical trials for Acute Graft Versus Host Disease

hAESCs Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation

Start date: July 31, 2024
Phase: Early Phase 1
Study type: Interventional

This is a parallel controlled clinical study evaluating the safety and efficacy of hAECs in preventing aGVHD after HSCT.

NCT ID: NCT06394895 Active, not recruiting - Clinical trials for Acute Graft-versus-Host Disease

Donor Neutrophil Subsets to Predict the Risk of aGVHD

Start date: December 1, 2023
Phase:
Study type: Observational [Patient Registry]

This is a prospective study to explore the association between donor neutrophil subsets and acute graft-vs.-host disease outcomes. Approximately 260 subjects (including 130 donors and 130 corresponding recipients) will be recruited.

NCT ID: NCT06386445 Not yet recruiting - Acute Kidney Injury Clinical Trials

Study on the Serum Metabolic Markers and Early Complications After Allo-HSCT: Cohort Study

Start date: May 1, 2024
Phase:
Study type: Observational

This study aims to establish a cohort of 500 patients with hematological disease who undergoing allogeneic hematopoietic stem cell transplantation in the northwest region. All patients will be followed up at the outpatient clinic once a week after transplantation until 100 days after transplantation to observe the presence of acute graft versus host disease, acute kidney damage, and major cardiovascular adverse events. Serum samples from the day before pre-treatment, day after pre-treatment, 2 weeks,4 weeks,8 weeks and 12 weeks after transplantation will be detected by metabolomics sequencing.The primary objective is to explore the serum metabolic markers of acute graft versus host disease,acute kidney injury, and major adverse cardiac events within 100 days after transplantation,the secondary objective is to observe the high-risk factors for early complications.

NCT ID: NCT06294691 Not yet recruiting - Clinical trials for Acute Graft-versus-host Disease

Effect of Stem Cell Infusion Time on aGVHD in Patients With Nonmalignant Hematologic Diseases

Start date: March 1, 2024
Phase: Phase 3
Study type: Interventional

To observe the effect of stem cell infusion on the development of acute graft- versus-host disease (aGVHD) in patients with nonmalignant hematologic diseases after allogeneic peripheral blood hematopoietic stem cell transplantation (allo-PBSCT)

NCT ID: NCT06294678 Not yet recruiting - Clinical trials for Acute Graft-versus-host Disease

Effect of Stem Cell Infusion Time on aGVHD in Patients With Hematological Malignancies

Start date: March 1, 2024
Phase: Phase 3
Study type: Interventional

To observe the effect of stem cell infusion on the development of acute graft-versus-host disease (aGVHD) in patients with malignant hematologic diseases after allogeneic peripheral blood hematopoietic stem cell transplantation (allo-PBSCT)

NCT ID: NCT06026371 Recruiting - Clinical trials for Acute Graft Versus Host Disease

Fecal Microbiota Transplantation for the Prevention of Acute Graft Versus Host Disease in Adults Undergoing Allogeneic Hematopoietic Cell Transplantation

Start date: December 12, 2023
Phase: Phase 2
Study type: Interventional

This randomized placebo-controlled double-blind phase II trial tests whether fecal microorganism (microbiota) transplantation prevents severe acute graft versus host disease in adults undergoing allogeneic hematopoietic cell transplantation (HCT). Fecal microbiota transplantation involves receiving processed fecal material orally after allogeneic HCT in order to establish a healthy gut microbiota. Gut microbiota undergoes major alterations during allogeneic HCT because of antibiotic exposures, nutritional changes, and chemotherapy administration. Establishing a healthy gut microbiota via fecal transplantation may help prevent acute graft versus host disease in patients undergoing allogeneic HCT.

NCT ID: NCT05921305 Recruiting - Clinical trials for Acute Graft Versus Host Disease

Mini-dose MTX Plus Standard-dose Steroid for the Initial Treatment of Acute GVHD

Start date: August 3, 2023
Phase: Phase 3
Study type: Interventional

This trial is a randomized (1:1) phase III open label study of frontline mini-MTX plus methylprednisolone 2mg/kg/day compared to methylprednisolone 2mg/kg in allogeneic stem cell transplant recipients with grade 2-4 aGVHD.

NCT ID: NCT05825833 Completed - Clinical trials for Acute Graft-versus-host Disease

Infliximab Efficacy in Relation to Therapeutic Drug Monitoring and Serum TNFα Levels in Pediatric HSCT

Start date: March 10, 2022
Phase:
Study type: Observational

Despite significant progress in overall survival and event-free survival in Pediatric Hematopoietic Stem Cell Transplant (HSCT), therapeutic options for graft-versus-host disease control remain limited, particularly in steroid-refractory patients. Several strategies have been proposed in the last 20 years but so far, the results have been inconclusive, complicated by the small population afflicted, inconsistent treatment schedules, different disease classifications and diagnosis methods. The number of studies concerning pediatric patients are even smaller. First line therapy for acute graft-versus-host disease (aGVHD) is steroid treatment that achieve partial or complete remission of the disease in a variable percentage of cases (40-60%), depending mainly to severity of GVHD and number of organ involvement, with hepatic and gastrointestinal GVHD particularly refractory to steroid treatment. For second line therapy there is no a standardized strategy with a great variety of immunosuppressive treatment without a real superiority of a drug in comparison to another. Steroid refractory acute GVHD is therefore one of the most important challenges in HSCT field. One of the more promising routes, based on published data and clinical experience, is the off-label use of Infliximab, an anti-Tumor Necrosis Factor α drug (already approved for many rheumatologic and autoimmune diseases) administered as a second line treatment in patients with steroid-refractory aGVHD at the standardized dosage of 10 mg/kg, although limited evidence has been published to validate this subscription. Biological pattern that could explain susceptibly of GVHD to infliximab treatment could lie in physiopathology of acute gastrointestinal GVHD that may resemble ulcerative rectocolitis. In this case, relation to Therapeutic Drug Monitoring (TDM) and Tumor Necrosis Factor α (TNFα) levels could be critical in monitoring the efficacy of the drug and need of further doses. Limited published data and clinical experience show that Infliximab may be able to further control symptoms and inflammatory response in a promising percentage of treated patients, although some have no benefit from the treatment. The aim of this study is to analyze the role of TNFα concentration in aGVHD, its levels fluctuation and clinical response of GVHD to Infliximab treatment in steroid-refractory pediatric patients.

NCT ID: NCT05823675 Recruiting - Clinical trials for Acute Graft Versus Host Disease

Safety and Clinical Activity of Itolizumab in aGVHD

Start date: May 19, 2023
Phase: Phase 1
Study type: Interventional

To evaluate the safety, tolerability, PK, PD, and clinical activity of Itolizumab in subjects with Newly diagnosed Acute Graft Versus Host Disease(aGVHD).

NCT ID: NCT05673876 Terminated - Clinical trials for Acute Graft-versus-host Disease

A Study to Assess the Safety and Pharmacokinetics of GDC-8264 in Combination With Standard of Care in Participants With Acute Graft-Versus-Host Disease (aGVHD)

Start date: April 6, 2023
Phase: Phase 1
Study type: Interventional

The primary purpose of the study is to assess the safety and pharmacokinetics (PK) of GDC-8264 in participants with acute graft-versus-host disease (aGVHD).