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Graft vs Host Disease clinical trials

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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: NCT03456817 Recruiting - Relapse Clinical Trials

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

ATG2017
Start date: July 1, 2020
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 with low-dose CSA minimizes the chances of relapse and chronic GVHD, without increasing the chances of other transplant complications.

NCT ID: NCT03438643 Recruiting - Clinical trials for Graft Versus Host Disease

Dynamic of Immunocompetent Populations in Patients Treated With Extracorporeal Photopheresis in Chronic Graft Versus Host Disease

IMMUNO-PEC
Start date: May 7, 2018
Phase:
Study type: Observational

Extracorporeal photopheresis (ECP) is a cellular therapy indicated in the treatment of chronic GVHD (cGVHD). In this study protocol, patients suffering from inaugural cGVHD will be treated with the association of ECP and corticosteroid treatment. Treatment will start by an induction stage with 2 sessions of ECP per week until the 10th week followed by a maintenance stage including one session every other week until the 22th week. The objective of this study is to highlight the immunological mechanism of extracorporeal photopheresis treatment. Indeed, ECP is based on an immunomodulatory immunological effect and despite several hypotheses highlighted by different teams; clear mechanisms still need to be defined. This French multicenter study realize an immunological follow-up before and during treatment to elucidate the impact of ECP on immune system of responder patient.

NCT ID: NCT03434730 Active, not recruiting - Leukemia Clinical Trials

Tocilizumab for the Prevention of Graft Versus Host Disease After Cord Blood Transplantation

Start date: February 7, 2018
Phase: Phase 2
Study type: Interventional

The aim of the research in this study is to make participants' transplant safer by reducing the risk of developing GVHD and GVHD-related complications by giving participants a dose of the drug tocilizumab in addition to the standard approach for GVHD prevention. Tocilizumab reduces the risk of inflammation by blocking the effect of Interleukin-6, a protein that exists in high levels in the blood when there is inflammation. Participants who receive stem cell transplants have high levels of this protein in their blood early after transplant. Therefore, the goal of this study is to reduce the risk of inflammation after transplant with the addition of Tocilizumab. This could decrease the risk of developing GVHD and GVHD-associated complications.

NCT ID: NCT03434704 Completed - Clinical trials for Myelodysplastic Syndromes

Peripheral Blood Stem Cell Transplantation From Family Haploidentical Donors in Patients With Myelodysplastic Syndrome and Acute Leukemia Under Primary Prophylaxis With Posaconazole

SIR-POSA
Start date: June 18, 2018
Phase: Phase 2
Study type: Interventional

SIR-POSA is a phase II trial of peripheral blood stem cell (PBSC) transplantation from a partially compatible family (Haplo) donor in patients with a blood tumor (myelodysplastic syndrome (MDS) and acute leukemia) treated for the prevention of primary fungal infections with posaconazole. The aim is evaluate the composite end-point graft-versus-host disease-free, relapse-free survival (GRFS) in these patients and evaluate the feasibility and efficacy of posaconazole oral tablets as primary antifungal prophylaxis.

NCT ID: NCT03422627 Terminated - Clinical trials for Chronic Graft Versus Host Disease cGVHD

Safety and Efficacy of Efavaleukin Alfa in Subjects With Steroid Refractory Chronic Graft Versus Host Disease

Start date: April 27, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Phase 1b: To evaluate the safety and tolerability of multiple ascending doses of efavaleukin alfa in subjects with steroid refractory chronic graft versus host disease (cGVHD). Phase 2: To evaluate the efficacy of efavaleukin alfa in subjects with steroid refractory cGVHD as measured by overall response rate (ORR) at 16 weeks according to the 2014 cGVHD NIH Consensus Criteria. Due to early termination, the Phase 2 portion of this study was not conducted.

NCT ID: NCT03419078 Completed - Clinical trials for Graft Versus Host Disease

Nutrition and Outcomes of Hematopoietic Cell Transplantation (HCT)

Start date: December 2015
Phase:
Study type: Observational

Retrospective case-note review to determine if nutrition via the enteral compared to the parenteral route results in better outcomes after haematopoietic cell transplantation.

NCT ID: NCT03415867 Active, not recruiting - Clinical trials for Sclerodermoid Chronic Graft-Versus-Host Disease (Disorder)

Glasdegib in Refractory Patients With Sclerotic Chronic Graft-Versus-Host Disease

Start date: January 9, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase 1b/2a, open label, multi-centre, safety and efficacy study of glasdegib in patients with sclerotic cGVHD refractory to second-line treatment. The design for the current study is a standard 3+3 dose-finding scheme. A dose escalation/de-escalation design will be applied in successive patient cohorts until identification of MTD. Glasdegib will be self-administered orally once daily in the morning as monotherapy in continuous 28-day treatment cycles for a maximum of 24 cycles. Those patients enrolled in the trial that obtain objective clinical benefit under treatment with glasdegib (defined as the achievement of at least a partial response at one or more target organs), will be allowed to proceed to a slow dose withdrawal phase over a period of 6 months after the end of Cycle 24.

NCT ID: NCT03414645 Completed - Dry Eye Clinical Trials

Topical Fibrinogen-Depleted Human Platelet Lysate in Patients With Dry Eye Secondary to Graft vs. Host Disease

Start date: May 1, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this Phase 1/2 study is to compare the safety and tolerability of four times a day (QID) dosing of a non-preserved topical ocular drop formulation of 10 vol/vol % and 30 vol/vol % of FD hPL to vehicle control eye drops in patients with Dry Eye Disease (DED) secondary to Graft vs. Host Disease (GvHD).

NCT ID: NCT03395860 Recruiting - Prophylaxis Clinical Trials

Low Dose ATG Plus Low Dose PTCy as GVHD Prophylaxis in Haplo-HSCT

ATG/PTCy
Start date: May 30, 2017
Phase: Phase 2
Study type: Interventional

Low dose Rabbit Antithymocyte Globulin plus Low-dose post-transplantation cyclophosphamide as graft-versus-host disease prophylaxis in haploidentical hematopoietic stem cell transplantation for patients with hematologic malignancies