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GVHD clinical trials

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NCT ID: NCT03605927 Completed - GVHD Clinical Trials

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

Start date: February 15, 2019
Phase: Phase 1
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: NCT03459040 Completed - 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: NCT03233659 Completed - GVHD Clinical Trials

Immune Monitoring After Allogeneic Hematopoietic Stem Cell Transplantation

Start date: August 12, 2014
Phase:
Study type: Observational

Graft versus Host disease ( GVHD) is one of the major complications of Allogeneic Stem Cell Transplantation. Acute GVHD develops early ( within 2to 3 months) after transplantation and is the leading cause of death of transplanted patients. The pathogenesis of Chronic GVHD is still little known. Chronic GVHD is caused by donor T lymphocytes, but we have no precise knowledge on the participation of specific subsets of immune system cells to chronic GVHD. In general, chronic GVHD is associated with an increase in the number of T effector lymphocytes, both helper type 2 and cytotoxic. Recently, also antigen presenting cells (APCs) have been implicated in pathogenesis of chronic GVHD in studies performed on animal models. T lymphocyte responses that characterize chronic GVHD require that recipient antigens are submitted by APCs which originate from the donor's HSC ( Hematopoietic Stem Cells) APCs are heterogeneous population that includes dendritic cells (DCs) ,monocytes, activated B lymphocytes and CD34+ cell subpopulations. These cells can be identified by cytometry. The data about APCs role in chronic GVHD are preliminary and often discordant. Seemingly, there isn't correlation between circulating APCs number and risk of cGVHD. However, recent data of our group show that patients with cGVHD could have higher number of monocytes in bone marrow than transplanted patients without cGVHD. The aim of study is to measure the number of circulating immune cells in the PB (peripherical blood) before and after Allogeneic Hematopoietic Stem Cell Transplantation by flow cytometry.

NCT ID: NCT03188601 Completed - GVHD Clinical Trials

α1-antitrypsin (AAT) Levels and Functions in Allogeneic Bone Marrow Transplantation and Throughout Progression Into GVHD

AATGVHD-MARK
Start date: January 27, 2018
Phase:
Study type: Observational [Patient Registry]

Create a personalized time and context curve of patient circulating α1-antitrypsin (AAT) levels and functions before hematopoietic stem cell transplantation and throughout progression into GVHD. PRIMARY ENDPOINT 1. Serum AAT levels and activity, before myeloablative preconditioning, as well as on days (-3),0,7,14,28 from HSCT and every 21 days thereafter. SECONDARY ENDPOINTS 1. Correlation between AAT patterns and: - Circulating immune cell activation profiles on day of ablation, 28 days from HSCT and once GVHD is diagnosed. - Patient survival - Liver function tests - GVHD grade: skin manifestations, weight, GI and liver histopathology - Graft-versus-leukemia effect

NCT ID: NCT02942173 Completed - Lymphoma Clinical Trials

CD45RA Depleted T-cell Infusion for Prevention of Infections After TCRab/CD19-depleted Allo-HSCT

Start date: October 2016
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this prospective randomized study is to determine whether infusions of T-memory cells prevent infections in children with leukemia after allogeneic alpha, beta T-cell receptor (TcRab)/CD19-depleted hematopoietic stem cell transplantation (HSCT).

NCT ID: NCT02891603 Completed - Clinical trials for Graft Vs Host Disease

A Phase I/II GVHD Prevention Trial Combining Pacritinib With Sirolimus-Based Immune Suppression

Start date: June 8, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to examine a new approach to preventing a serious problem after transplant called graft vs. host disease (abbreviated as GVHD). This is a 3 arm sequential phase I/II, study of Pacritinib with Sirolimus and Tacrolimus (PAC/SIR/TAC) for the prevention of acute GVHD after matched related and unrelated allogeneic hematopoietic cell transplantation (alloHCT).

NCT ID: NCT02712762 Completed - Dry Eye Clinical Trials

Ocular Surface Disease in Chronic Graft-Versus-Host Disease (GVHD) Patients

Start date: June 2016
Phase:
Study type: Observational

This study aims to profile the ocular surface inflammation of chronic Graft-Versus-Host Disease patients by investigating conjunctival cells, and clinical imaging for conjunctival redness and tear stability. Hence, the investigators expect to find an increased in inflammatory cell population in GVHD conjunctival samples.

NCT ID: NCT02588339 Completed - Clinical trials for Graft Versus Host Disease

Panobinostat (LBH589): Acute Graft Versus Host Disease (aGVHD) Prevention

Start date: March 4, 2016
Phase: Phase 2
Study type: Interventional

This study will test PANO in combination with tacrolimus/sirolimus (TAC/SIR) for acute GVHD prevention. The purpose of this study is to determine if Panobinostat (PANO) when used in combination with sirolimus and tacrolimus will help reduce the incidence of Graft-vs-host disease (GVHD).

NCT ID: NCT02490163 Completed - GvHD Clinical Trials

Comparison of Two Automated Mononuclear Collection Systems in Patients Undergoing Extracorporeal Photochemotherapy. A Cross-over Equivalence Study. (MNC_CMNC)

CMNC_MNC
Start date: August 2015
Phase: Phase 3
Study type: Interventional

In a study performed in 2012, the investigators demonstrated that in ECP setting , the new automated device (Spectra Optia-MNC) released by Terumo BCT for MNCs collection based on intermittent flow is safe and ensures high-quality MNC collection and yield.(5, 6) More recently (in 2013), Terumo BCT released another automated system that allows to collect stem cells and MNCs basing on a continuous collection flow.(7, 8) The aim of this cross-over study is to compare yield (i.e. collection efficiency, CE) and quality (i.e. purity and contamination) of MNCs collected from patients undergoing ECP with two different automated systems: MNC and CMNC (Terumo BCT) processing 1.5 blood volumes during every collection procedure.

NCT ID: NCT02441075 Completed - GVHD Clinical Trials

70% Ethanol for Decontamination of CVL Exposed to Calcineurine Inhibitors Version 1.0, 1/9/2014

70% EtOH
Start date: May 2014
Phase: N/A
Study type: Interventional

This is for a study for patients that will be undergoing hematopoietic stem cell transplant (HSCT). For HSCT, patients will need a double lumen central venous line (CVL). One of the most common complications after an HSCT is Graft Versus Host Disease (GVHD).Tacrolimus or Cyclosporine along with methotrexate are used together in order to prevent GVHD. Normally these medications are given via the white lumen and blood is drawn via the unexposed red lumen to check the blood level of these medications. If these drugs are accidentally given via the wrong lumen (line) it could cause blood levels to be falsely high. This error could lead to the patient having to have peripheral blood draws that cause pain. The investigators are proposing adding an ethanol lock to your lumens (lines) to see if this would help clean the lines therefore preventing errors in blood tests and blood draws. An ethanol lock is a 70% alcohol which is injected into the CVL lumen and stays within the CVL as the CVL is capped.