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Graft vs Host Disease clinical trials

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NCT ID: NCT02841995 Completed - Clinical trials for Graft vs Host Disease

A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease

Start date: September 15, 2016
Phase: Phase 2
Study type: Interventional

This study was been conducted to evaluate the safety, tolerability, and activity of belumosudil (formerly known as KD025) in adult participants with chronic graft versus host disease (cGVHD).

NCT ID: NCT02824653 Completed - Clinical trials for Graft Versus Host Disease

Allogenic Bone Marrow Mesenchymal Stem Cells Infusion in Patients With Steroid-refractory GVHD

Start date: January 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Graft versus host disease is a serious and often life-threatening complication in allogeneic haematopoietic stem cell transplantation. Although corticosteroids are the first-choice of treatment in these patients, but about 30-50% patients do not respond to it and develop steroid-refractory GVHD. Mesenchymal stem cells (MSC) have emerged as a promising treatment option in these patients. This phase-I/II clinical trial aims at establishing the safety and clinical efficacy of allogenic ex-vivo cultured MSCs to treat steroid-refractory GVHD in a Pakistani HSCT cohort.

NCT ID: NCT02812940 Completed - Clinical trials for Graft-versus-Host Disease

Single-centre Study of Everolimus as GvHD Prophylaxis After Post-Transplantation Cyclophosphamide After Allogeneic SCT

OCTET-Ever
Start date: April 2016
Phase: Phase 2
Study type: Interventional

A phase II clinical study to assess the efficacy of short-term everolimus as prophylaxis for Graft-versus-Host disease (GvHD) in addition to post-transplantation cyclophosphamide after allogeneic hematopoietic stem cell transplantation in patients with haematological malignancies

NCT ID: NCT02805946 Completed - Clinical trials for Acute Graft Versus Host Disease

Pharmacokinetics of Posaconazole (Noxafil®) as Prophylaxis for Invasive Fungal Infections

PIRAÑA
Start date: April 28, 2017
Phase: Phase 4
Study type: Interventional

This study evaluates the the pharmacokinetics of posaconazole (new solid oral and IV) given as prophylaxis to patients who are at risk for developing fungal infections after receiving conditioning therapy (except strictly non-myeloablative (NMA)) for allogeneic Stem Cell Transplant (SCT), remission induction chemotherapy for acute myeloid leukemia (AML) or myelo dysplastic syndrome (MDS) or being treated for severe graft versus host disease (GvHD) and determines the impact of mucositis on the pharmacokinetics of posaconazole new solid oral.

NCT ID: NCT02749084 Completed - Clinical trials for Chronic Graft Versus Host Disease

Multiple Donor Treg DLI for Severe Refractory Chronic GVHD

TREG2015001
Start date: August 3, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This is a INTERVENTIONAL TRANSPLANTATION STUDY WITHOUT DRUGS. The INTERVENTION is represented by the INFUSION of DONOR T REGULATORY CELL-ENRICHED LYMPHOCYTES to PATIENTS suffering from REFRACTORY CHRONIC GVHD after ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION. The study includes a DOSE ESCALATION PHASE followed by a MTD PHASE as detailed in the following chapter. The primary objective of the dose escalation study will be SAFETY, leading to the definition of the MTD of T reg cells. For the MTD study the primary objective will be the OVERALL RESPONSE RATE at three months after the 3rd Treg infusion. The study is single center single arm open label and includes a DOSE ESCALATION phase followed by an EXTENDED PHASE with the MAXIMUM TOLERATED DOSE (MTD). The aim of the study is to assess whether multiple infusions of donor-derived purified T regulatory cells (T reg DLI) in patients with steroid-refractory chronic GVHD is safe and whether it may induce clinical remission of GVHD.

NCT ID: NCT02743351 Completed - Clinical trials for Acute Myeloid Leukemia

Study of ProTmune for Allogeneic HCT in Adult Patients With Hematologic Malignancies

Start date: December 20, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a Phase 1, non-randomized, open-label/Phase 2 randomized, blinded study of ProTmune (ex vivo programmed mobilized peripheral blood cells) versus non-programmed mobilized peripheral blood cells for allogeneic hematopoietic cell transplantation (HCT) in adult subjects aged 18 years and older with hematologic malignancies. A total of 88 study subjects were treated in the trial at approximately 15 centers in the US.

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: NCT02707354 Completed - Clinical trials for Graft Versus Host Disease

Early Detection of Mucosal Abnormalities in Graft-versus-host Disease

E-mage
Start date: June 3, 2016
Phase: N/A
Study type: Interventional

Gastro-intestinal graft versus host disease (GVHD) is a major source of morbidity and mortality amongst allogenic hematopoietic stem cell transplantation (Allo-HSCT). The diagnosis is based on histological findings that involve colonic biopsies with a risk of bleeding, especially in case of thrombocytopenia. Moreover the diagnosis is frequently made at a clinical stage of the disease, after the appearance of gastro-intestinal symptoms. Endo-microscopy is a novel endoscopic technique that allow "optical biopsies" during a conventional endoscopy and has proved its efficiency in several indications. In a pilot study the investigators showed that it had good sensibility and sensitivity compared to histology as gold standard. Therefore this study aim to identify endo-microscopic criteria allowing the early diagnosis of GHVD before its clinical manifestations.

NCT ID: NCT02687646 Completed - Clinical trials for Acute Graft Versus Host Disease

Clinical Trial With MSC for Graft Versus Host Disease Treatment

Start date: February 20, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Sequential administration of MSCs obtained from adipose tissue is an effective and safe treatment for acute graft versus host disease refractory to first-line treatment. Furthermore the infusion of these cells produces a biological pattern in patients that relates to the clinical response.

NCT ID: NCT02683525 Completed - Clinical trials for Graft vs Host Disease

Sitagliptin for Prevention of Acute Graft Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation

Start date: February 3, 2016
Phase: Phase 2
Study type: Interventional

Primary Objective Evaluate the efficacy of sitagliptin in reducing the incidence of grade II-IV acute Graft Versus-Host Disease (GvHD) by day +100 post-transplant in patients undergoing allogeneic hematopoietic stem cell transplantation and receiving standard sirolimus and tacrolimus GvHD prophylaxis. Secondary Objectives The following descriptive secondary objectives will be studied: 1. Describe the tolerability and potential toxicity of sitagliptin. 2. Describe the cumulative incidence of grades II-IV acute GvHD by day +100. 3. Describe the cumulative incidence of grades III-IV acute GvHD. 4. Describe the engraftment kinetics of absolute neutrophil count and platelets. 5. Describe the incidence of infections occurring during the 100 days post-transplant. 6. Describe non-relapse mortality (NRM) at day +30, +100, and 1 year post-transplant. 7. Describe overall survival. 8. Describe the incidence of chronic GvHD. 9. Describe the cumulative incidence of relapse of the primary hematological malignancy.