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Graft vs Host Disease clinical trials

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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: NCT05808985 Recruiting - Clinical trials for Graft Versus Host Disease

Intestinal Microbiome-based Research for the Prevention of Acute GVHD

Start date: September 2, 2022
Phase: Phase 2
Study type: Interventional

Hematopoietic stem cell transplantation consists of preconditioning chemotherapy, stem cell infusion, and engraftment of hematopoietic stem cells. In this process, in the case of recipients who receive hematopoietic stem cells, their immune system is completely destroyed and then undergoes a situation in which it is reconstituted. In this process, the diversity of the intestinal microbiome is reduced, and it is widely known that a severe decrease is associated with the occurrence of an acute graft-versus-host reaction. Attempts to improve the intestinal microbiome include prebiotics, probiotics, and postbiotics. Prebiotics can be expected to improve the intestinal microbiome by acting as nutrients for beneficial bacteria in the intestine, but their role may be limited in situations where the diversity of the intestinal microbiome has already decreased. Probiotics are a method to expect improvement of the intestinal microbiome by administering the beneficial bacteria themselves in the intestine, but there is a difficulty in reaching the intestine properly through stomach acid, and there is a risk of causing sepsis in immunocompromised patients. Postbiotics is a product that beneficial bacteria metabolize and release prebiotics in the intestine, and the microbiome in the intestine is actually responsible for the function that affects the human body. Therefore, in this study, postbiotics are administered to patients undergoing hematopoietic stem cell transplantation who are concerned that the diversity of the intestinal microbiome may have already decreased, to improve the intestinal microbiome and hope to prevent graft-versus-host reactions through this. Furthermore, it is intended to improve the outcome of allogeneic hematopoietic stem cell transplantation.

NCT ID: NCT05718791 Recruiting - GVHD,Acute Clinical Trials

CXCL9 and EASIX for Prediction of Acute Graft Versus Host Disease

Start date: May 10, 2023
Phase:
Study type: Observational

The prediction of severe acute GVHD before it occurs is of high importance for ensuing clinical decisions and overall success of allogeneic SCT. The key immunologic signatures associated with clinical outcomes after different graft versus host disease prophylaxis methods or peripheral blood stem cell transplant are largely unknown.

NCT ID: NCT05692713 Recruiting - Leukemia Clinical Trials

Polyomic Biomarker Verification in Adult Chronic Graft-Versus-Host Disease (ABLE3.0/CTTC2201)

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

Chronic graft-versus-host disease (cGvHD) is one of the most serious complications following BMT (Bone Marrow Transplantation). cGvHD occurs when donor immune cells "attack" the tissues and organs of the person receiving the BMT. cGvHD can be difficult to treat once it is established leading to poor quality of life for recipients of a BMT. The goal of this study is to determine if, by using biomarkers, the investigators can predict which patients are at the highest risk of developing cGvHD after BMT, before cGvHD develops. The ABLE3.0 / CTTC 2201 study will validate and potentially refine the initial predictive biomarker algorithm developed from the original ABLE/PBTMC 1202 study (ABLE1.0), allowing clinicians the ability to pre-emptively predict their patient's future risk of developing both late-acute and chronic GvHD. This will provide the foundation for the later development of clinical trials aimed at reducing immune suppression quicker after transplant for low-risk patients (<10% risk) and justifying more intensive approaches such as pre-emptive treatments before the onset of chronic GvHD in high-risk patients (>45% risk).

NCT ID: NCT05690971 Recruiting - Clinical trials for Chronic Graft-Versus-Host Disease

Psychosocial Mobile App for Chronic Graft-Versus-Host Disease

Start date: January 23, 2023
Phase: N/A
Study type: Interventional

The purpose of this research study is to see whether a psychosocial mobile app called Horizons is effective at improving quality of life, symptom burden, psychological distress, and coping in patients living with chronic graft-versus host disease (GVHD)

NCT ID: NCT05675930 Recruiting - Clinical trials for Graft-Versus-Host Disease

A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant

Start date: December 22, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out whether photobiomodulation/PBM therapy using the Thor LX2.3 therapy system is a safe and effective treatment for oral Graft-Versus-Host Disease/GVHD.

NCT ID: NCT05655546 Recruiting - HIV Infections Clinical Trials

ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of Immunocompromised Individuals

Start date: December 22, 2022
Phase: N/A
Study type: Interventional

The investigators will examine whether a combination of at-home nucleic acid amplification tests, on-demand telemedicine, and delivery of prescriptions such as Paxlovid quickly after testing positive for COVID-19, can reduce severe outcomes and hospitalization of immunocompromised patients and those who are 65 years and older. They will also analyze whether these efforts lower the cost of care compared to standard of care.

NCT ID: NCT05643638 Recruiting - Clinical trials for Graft Versus Host Disease, Acute

A Study of CYP-001 in Combination With Corticosteroids in Adults With High-risk aGvHD

Start date: March 4, 2024
Phase: Phase 2
Study type: Interventional

This study is a prospective randomized placebo-controlled phase 2 study to compare CYP-001 plus corticosteroids (CS) to placebo plus CS in allogeneic hematologic stem cell transplant recipients with HR-aGvHD. Severity of GvHD will be assessed at screening and throughout the study using Mount Sinai Acute GvHD International Consortium (MAGIC) guidelines. Eligible subjects will be randomized to receive either CYP-001 IV infusion on Days 0 and 4 or placebo on the same days. All subjects will receive ongoing CS therapy as appropriate per institutional guidelines. Subjects will have study visits up to Day 100 during the Primary Evaluation Period. During the Follow-Up Period, subjects will have study visits up to 24 months.

NCT ID: NCT05622318 Recruiting - Clinical trials for Graft-versus-host Disease

De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis

Start date: August 29, 2023
Phase: Phase 2
Study type: Interventional

This is an open-label phase 2 study designed to explore the efficacy and safety of low-dose PTCy-ruxolitinib GVHD prophylaxis in older adults undergoing allogeneic HCT with a matched sibling or unrelated donor with a peripheral blood stem cell graft.

NCT ID: NCT05621759 Recruiting - Clinical trials for Graft Vs Host Disease

Cyclophosphamide, Abatacept, and Tacrolimus for the Prevention of GvHD

Start date: August 23, 2022
Phase: Phase 2
Study type: Interventional

This is a single arm, open label, phase II clinical trial. Adult patients with hematological malignancies undergoing allogeneic HSCT from first- or second-degree haploidentical donor are eligible for the study if they meet the standard criteria defined in our institutional standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Patients will receive non-myeloablative, reduced-intensity or myeloablative conditioning regimen followed by peripheral blood hematopoietic stem cells. Patients will receive dosed reduced cyclophosphamide, abatacept, and short-duration tacrolimus for GvHD prophylaxis.