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Graft vs Host Disease clinical trials

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NCT ID: NCT03771222 Not yet recruiting - Relapse Clinical Trials

Prophylactic Donor Lymphocyte Infusion After Allo-PBSCT for Patients With Very High-risk Hematologic Malignancies

Start date: January 2019
Phase: Phase 2
Study type: Interventional

Unmanipulated allogenic peripheral blood stem cell transplantation (allo-PBSCT) has been an established treatment to cure high-risk leukemia/lymphoma. Relapse is the main cause of treatment failure for patients with relapsed/refractory disease or with very high-risk gene mutations such as TP53, TET2 and DNMT3a. Donor lymphocyte infusion (DLI) is an option to reduce relapse after allo-PBSCT for very high-risk disease without effective targeted therapy. In this study, the investigators aimed to compare the safety and efficacy of prophylactic DLI with G-CSF-primed peripheral blood progenitors for prevention of relapse after allo-PBSCT in patients with very high-risk leukemia/lymphoma.

NCT ID: NCT03764228 Recruiting - Clinical trials for Acute-graft-versus-host Disease

Human Amniotic Epithelial Cells Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation

hAECs-GVHD
Start date: July 1, 2020
Phase: N/A
Study type: Interventional

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

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: NCT03755414 Active, not recruiting - Clinical trials for Myelodysplastic Syndromes

Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation

Start date: September 4, 2019
Phase: Phase 1
Study type: Interventional

In this trial, the investigators will begin to explore the possibility that, as in mice, janus kinase inhibitor 1 (JAK1) inhibition with haploidentical-hematopoietic cell transplantation (HCT) may mitigate graft-versus-host-disease (GVHD) and cytokine release syndrome (CRS) while retaining Graft-versus-Leukemia (GVL) and improving engraftment. The purpose of this pilot study is to determine the safety of itacitinib with haplo-hematopoietic cell transplantation (HCT) measured by the effect on engraftment and grade III-IV GVHD.

NCT ID: NCT03731624 Recruiting - Dry Eye Syndromes Clinical Trials

Diadenosine Polyphosphates and Mucin Associated With Ocular Surface Disorders

Start date: January 1, 2018
Phase:
Study type: Observational [Patient Registry]

Dry eye disease, ocular graft-versus-host disease (GVHD), and superior limbic keratoconjunctivitis (SLK) are all ocular surface disorders which mostly involve the outer surface of the eye. Many of the ocular surface disorders may result from or be aggravated by the mechanical stress from eyelid blinking. Specifically, SLK is an inflammatory ocular surface disorder characterizing by redundant superior bulbar conjunctiva. Since redundant superior bulbar conjunctiva can cause a significant mechanical force during eyelid blinking, we found that conjunctival resection with Tenon's capsule excision is helpful in relieving the symptoms of SLK patients. Therapeutic contact lens, protecting the ocular surface from the microtrauma between eyelid and ocular surface, is also an effective treatment for severe dry eye disease, ocular GVHD, and SLK. Although shearing force/mechanical stress has been studied in many different tissues and disease entities, the impact of shearing force over ocular surface is still unclear. While the importance of mechanical stress in ocular surface disorder has been reported, the specific molecule involving the pathogenesis is still unknown. Diadenosine polyphosphates are a family of dinucleotides. They can enhance tear secretion and increase corneal wound healing rate from previous reports. Shear-stress stimuli was also noted to be able to induce diadenosine polyphosphates releasing from human corneal epithelium. In addition, mucin, one of the three components of tear film, has been greatly emphasized in the pathogenesis of dry eye disease. There are also some reports about the shearing force compensating the mucin contents in the inflammatory lung/bowel diseases. If diadenosine polyphosphates or mucin indeed play a role in mechanical stress-related ocular surface disorders, it will be a promising therapeutic targeting in the future.

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: NCT03721965 Terminated - Clinical trials for Acute Graft-versus-host Disease

Safety and Efficacy of Itacitinib in Combination With Corticosteroids for Treatment of Graft-Versus-Host Disease in Pediatric Subjects

Start date: December 31, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate itacitinib in combination with corticosteroids for the treatment of Grades II to IV acute graft-versus-host disease (aGVHD) in steroid-naive pediatric participants.

NCT ID: NCT03717480 Terminated - Clinical trials for Hematologic Malignancy

Ex Vivo TCR αβ T Cell Depletion for Graft-Versus-Host Disease Prophylaxis in Mismatched Donor Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies

Start date: January 21, 2020
Phase: Phase 2
Study type: Interventional

This research study is studying the removal of a subset of white blood cells (called alpha/beta T cells) from the donor product using a cell separation device before the product is transplanted into the participant. The device used to remove the α/βT cells in this study is: -CliniMACS® TCR α/β Reagent System

NCT ID: NCT03689894 Terminated - Clinical trials for Chronic Graft-versus-host-disease

Ibrutinib Plus Rituximab for cGVHD Following Allo-SCT

Start date: April 11, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Allogeneic stem cell transplant is used to treat a variety of blood cancers. However, graft-versus-host disease (GVHD) is a common condition that may occur after transplant. GVHD happens when the donor cells attack and damage the recipients' tissue. The standard medication to treat chronic graft-versus-host-disease (cGVHD) is corticosteroids. However, there are long-term side effects of steroid therapy, including risk of infection, bone loss and other health problems. In addition, some patients with cGVHD do not respond to standard steroid therapy. In these cases, medications to suppress the immune system may be used. The purpose of this study is to learn about the effects, both good and bad, of combining the drugs ibrutinib and rituximab for the treatment of cGVHD. Ibrutinib is Food and Drug Administration (FDA)-approved for the treatment of cGVHD which has not responded to steroid therapy. Rituximab is an investigational drug, which means it is not FDA approved for this particular use. Rituximab is currently approved for treatment of Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), and other conditions, but is not FDA approved for the treatment of cGVHD. However, rituximab has been used in a clinic setting for the treatment of cGVHD in a number of patients over the past few years, and has generally been well tolerated and shown some benefit. The combination of ibrutinib and rituximab is being studied in the treatment of certain types of lymphoma and chronic leukemia, but it has not yet been combined for patients with cGVHD. Because ibrutinib is not approved for this use when combined with rituximab, it is considered investigational in this study. In this form, the term "study drug" refers to ibrutinib and rituximab. This study will involve people who have chronic GVHD, have previously taken corticosteroids, and have either not benefited from treatment with corticosteroids or have been unable to successfully taper off steroids.

NCT ID: NCT03689465 Recruiting - Clinical trials for Hematopoietic Stem Cell Transplantation

PTCy-ATG vs ATG in Haploidentical HSCT for Acute Graft-versus-host Disease Prophylaxis

Start date: October 29, 2018
Phase: Phase 4
Study type: Interventional

The granulocyte colony-stimulating factor (G-CSF)+antithymocyte globulin (ATG)-based protocols and posttransplantation cyclophosphamide (PTCy) protocols have been widely used for graft-versus-host disease (GVHD) prophylaxis in haploidentical related donor transplantation (haplo-HSCT). Nevertheless, severe acute GVHD remains an obstacle for haplo-HSCT. This study is aim to evaluate the efficacy of a modified protocol that includes PTCY and ATG in recipients of haplo-HSCT.