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Graft vs Host Disease clinical trials

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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: NCT04038827 Completed - Clinical trials for Endothelial Dysfunction

Origin of CEC in Patients After Allo-HSCT

DCEC-PIANO
Start date: August 27, 2019
Phase:
Study type: Observational

We believe that CEC, besides coming from cells shedding from patient vasculature, could partly belong to donor, originating from the cellular graft.

NCT ID: NCT04014790 Completed - Clinical trials for Graft Vs Host Disease

RGI-2001 for the Prevention of Acute Graft-vs-Host Disease in Subjects Following Allogeneic Hematopoietic Stem Cell Transplantation

Start date: November 25, 2019
Phase: Phase 2
Study type: Interventional

This Phase II open label study will evaluate the safety and efficacy of repeat doses of RGI-2001 in combination with standard of care treatment for the prevention of acute graft-vs-host-disease (aGvHD) in subjects following Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT). These subjects will be compared to contemporary controls.

NCT ID: NCT03990051 Completed - Clinical trials for Chronic Ocular Graft-versus-host Disease

Treatment Safety and Efficacy of Pro-ocularâ„¢ 1% for Chronic Ocular Graft Following Allogeneic HSCT.

Start date: October 17, 2019
Phase: Phase 2
Study type: Interventional

To evaluate the safety and efficacy of Pro-ocularâ„¢ 1% topical gel administered twice daily for 70 days in reducing or eliminating symptoms and signs of chronic ocular GvHD.

NCT ID: NCT03954236 Completed - Clinical trials for Non-sclerotic Cutaneous Chronic Graft-versus-host Disease

Study of the Safety and Efficacy of Ruxolitinib Cream for Non-Sclerotic Chronic Cutaneous Graft-Versus-Host Disease

Start date: May 14, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare the safety and effects of ruxolitinib 1.5% cream with those of standard moisturizers in people with non-sclerotic chronic cutaneous GVHD.

NCT ID: NCT03945591 Completed - GVHD Clinical Trials

High-Dose Post-Transplant Cyclophosphamide and Bortezomib (CyBor) for the Prevention of Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Start date: June 20, 2019
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 matched-related or unrelated 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 or myeloablative conditioning regimen of fludarabine, busulfan, and rabbit anti-thymocyte globulin (rATG). Patients will receive PTCyBor as GvHD prophylaxis.

NCT ID: NCT03846479 Completed - GVHD Clinical Trials

Itacitinib for Low Risk GVHD

Start date: March 25, 2019
Phase: Phase 2
Study type: Interventional

Graft-versus-host disease (GVHD) is treated with high doses of systemic steroids which can lead to serious complications. A new blood test can identify patients whose GVHD is most likely to respond to well to treatment (low risk GVHD). This study will test whether patients with low risk GVHD can be successfully treated without steroids. Patients who participate with this study will be treated with itacitinib instead of steroids. Itacitinib is an experimental drug with an excellent safety record and appears to have activity as a GVHD treatment.

NCT ID: NCT03763318 Completed - GVHD Clinical Trials

A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD

EQUATE
Start date: July 15, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of EQ001 in subjects with Acute Graft Versus Host Disease (aGVHD).

NCT ID: NCT03727113 Completed - Clinical trials for Graft Versus Host Disease

Optimization of Antibiotic Treatment in Hematopoietic Stem Cell Receptors

Optimbioma
Start date: January 16, 2018
Phase:
Study type: Observational

There are data suggesting that the reduction of the diversity of intestinal microbiota caused by the used treatments in the setting of allogeneic hemopoietic stem cell transplant (ASCT), and specially antibiotics, may be related to increased incidence of graft versus host disease (GVHD) and worst clinical outcomes. Present "European Conference on Infections in Leukaemia" guidelines exhort to antibiotic treatment optimization in hematological patients, without excluding ASCT receptors. This study aims to demonstrate that in ASCT receptors a predefined protocol of optimization of the antibacterial treatment will preserve the intestinal microbiota diversity which will correlate with decrease incidence of acute GVHD. And that this procedure is safe because it will not worsen the incidence of infections, transplant related mortality, infectious mortality or global survival.

NCT ID: NCT03683498 Completed - Clinical trials for Chronic Graft vs Host Disease

Donor Regulatory T-cells for Steroid-Refractory Chronic Graft-versus-host-Disease

GVHD-TReG
Start date: September 25, 2018
Phase: Phase 1
Study type: Interventional

A Phase I Trial of Donor Regulatory T-cells for Steroid-Refractory Chronic Graft-versus-Host-Disease in patients who do not obtain complete remission with ruxolitinib