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Graft Versus Host Disease clinical trials

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NCT ID: NCT03842696 Not yet recruiting - Clinical trials for Myelodysplastic Syndromes

Vorinostat for Graft vs Host Disease Prevention in Children, Adolescents and Young Adults Undergoing Unrelated Donor Blood and Marrow Transplantation

Start date: March 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the recommended phase 2 dose of the drug Vorinostat in children, adolescents and young adults following allogeneic HCT and determine whether the addition of Vorinostat to the standard preventive therapy (tacrolimus / methotrexate) will reduce the incidence of graft versus host disease (GVHD) following unrelated donor, myeloablative transplant in children, adolescents and young adults.

NCT ID: NCT03818334 Recruiting - Clinical trials for Graft Versus Host Disease

Post Transplant Cyclophosphamide in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies

Start date: November 6, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This study aims to evaluate the clinical efficacy of cyclophosphamide in patients receiving a bone marrow graft from a matched unrelated donor in overall survival, progression free survival and cumulative incidence of acute and chronic GvHD. Thirty patients will receive cyclophosphamide while twenty patients will receive antihuman T-lymphocyte immune globulin (ATG).

NCT ID: NCT03805789 Recruiting - Clinical trials for Graft Versus Host Disease

The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft‑Versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell Transplant

MODULAATE
Start date: February 2019
Phase: Phase 2/Phase 3
Study type: Interventional

This study is a Phase 2/3 prospective, double-blind, randomized, multi-center, placebo‑controlled study for prevention of acute GVHD (aGVHD) in subjects undergoing an allogeneic hematopoietic cell transplant (HCT).

NCT ID: NCT03771222 Not yet recruiting - Clinical trials for Graft-versus-host Disease

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: NCT03727113 Recruiting - 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: NCT03605927 Recruiting - GVHD Clinical Trials

CD40-L Blockade for Prevention of Acute Graft-Versus-Host Disease

Start date: January 24, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to examine the safety and efficacy of the addition of BMS-986004 to standard of care Sirolimus (SIR)-based immune suppression.

NCT ID: NCT03602599 Recruiting - Clinical trials for Graft Versus Host Disease

Chronic Graft-versus-Host Disease in the Oral Cavity of Patients Following Allogeneic Hematopoietic Stem Cell Transplant and Including Healthy Controls

Start date: November 15, 2018
Phase:
Study type: Observational

Background: This study follows people who have had, or will soon have, a transplant using stem cells from another person. This is known as an allogeneic hematopoietic stem cell transplant (HSCT). Graft-versus-host disease (cGVHD) can happen after HSCT. cGVHD can cause mouth problems and more serious issues. Researchers want to study changes in the mouth that might indicate cGVHD. Objective: To identify cGVHD in the mouth and better understand the development, treatment, and progress of post-transplant changes in the mouth. Eligibility: Adults at least 18 years old who will soon undergo HSCT or have had one in the past 3 years Healthy adults at least 18 years old Design: All participants will have a screening visit and baseline visit. They will last 60-90 minutes. Over these two visits, participants will have: Medical and dental history Dental exam. Questions about their eating habits and general health Blood drawn through a needle in the arm Vital signs taken Pictures of their mouth and lips taken Questions about their oral health, including about pain, sensitivity, or dryness Saliva samples taken. Participants will spit into a sterile plastic tube. Swabs taken of the mouth and some of the saliva, plaque, and fluid from the spaces between teeth and gums. Participants may also have: A piece of skin taken (biopsy) from the inner lining of the cheeks A piece of skin taken (biopsy) from the lower lip Dental X-rays Urine pregnancy test Most participants will have at least 7 study visits over 3 years. They will meet with a dentist and repeat baseline tests.

NCT ID: NCT03591874 Recruiting - Clinical trials for Graft Versus Host Disease

Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease

oGVHD
Start date: September 18, 2018
Phase: Phase 3
Study type: Interventional

This study evaluates the use of Brimonidine tartrate nanoemulsion eye drop solution in the treatment of ocular Graft Verses Host Disease (oGVHD). Two thirds of participants will receive Brimonidine and one third will receive ophthalmic buffered saline (placebo).

NCT ID: NCT03459040 Recruiting - GVHD Clinical Trials

A Proof of Concept Pilot Trial of Alpha-1-Antitrypsin for Pre-Emption Of Steroid-Refractory Acute GVHD

Start date: August 17, 2018
Phase: Phase 2
Study type: Interventional

Bone marrow transplant (BMT) patients can develop graft-versus-host disease (GVHD), a serious and potentially fatal complication. The researchers have developed a blood test to identify patients most at risk for developing severe GVHD. Patients who consent to this study will have their blood tested up to two times after BMT to determine if they are at high risk for severe GVHD. The tests will be performed one week and two weeks after BMT. Patients who are high risk will be treated with a drug called alpha-1-antitrypsin (AAT) to see if it prevents the development of severe GVHD. Patients will receive 16 doses of AAT through a catheter placed into a blood vessel over eight weeks. AAT will be given either in the hospital or the outpatient clinic two times per week. Patients will be followed for the development of severe GVHD for up to four months from the BMT and will continue to be followed at routine clinic visits for up to one year after BMT.

NCT ID: NCT03456817 Not yet recruiting - Relapse Clinical Trials

HIgh Dose Thymoglobulin Instead of Cyclosporine With a Low Dose of Thymoglobulin for GVHD Prophylaxis

ATG2017
Start date: October 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out whether compared to our standard low dose ATG with CSA, the high dose ATG without CSA minimizes the chances of relapse and chronic GVHD, without increasing the chances of other transplant complications.