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Graft vs Host Disease clinical trials

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NCT ID: NCT03584516 Terminated - Clinical trials for Chronic Graft-versus-host Disease

GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

Start date: January 17, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of itacitinib in combination with corticosteroids as first-line treatment for moderate or severe chronic graft-versus-host disease (cGVHD).

NCT ID: NCT03575767 Completed - Clinical trials for Graft Vs Host Disease

Characteristics and Dynamics of TCR Repertoire in Patients With Hematological Malignancies After Allo-HSCT

Start date: May 8, 2018
Phase:
Study type: Observational [Patient Registry]

Graft-versus-Host Disease (GVHD) and relapse, which is mainly due to lack of Graft-versus-Leukemia (GVL), are the most frequent and severe complications of allogeneic hematopoietic stem cell transplantation (allo-HSCT). T cells expanded from mature T cells in the graft play a dominant role in development of GVHD and GVL early after allo-HSCT. Recent applications of high-throughput sequencing (HTS) to the T cells repertoire open a new avenue for us to look deeply into how these T cells dynamically adjust in the context of the recipient's environment. The main goal of this research study is to set up a mathematical model based on T cell receptor (TCR) sequencing to enable prediction for the key immunologic outcomes early post-transplantation. This study will deepen the understanding of the molecular mechanisms driving the most deadly post-transplantation complications, and serve as convincing evidence upon which to choose a better donor and a more proper transplantation approach. This observational trial will perform HTS for TCR β-chain complementarity determining region 3 (CDR3) repertoires of grafts and peripheral blood samples from recipients post-transplantation and analyze the relationship between dynamics of TCR CDR3 repertoires and clinical outcomes early post-transplantation, especially including GVHD and relapse. The investigators want to know how the antigen environment in recipients drives dynamics of mature T cells from grafts in order to use the new discovered rules to better predict and treat the disease process.

NCT ID: NCT03557749 Terminated - Clinical trials for Cytokine Release Syndrome

Monitoring of Immune and Microbial Reconstitution in (HCT) and Novel Immunotherapies

Start date: September 21, 2018
Phase:
Study type: Observational

This protocol serves as a mechanism to collect, store, and distribute bodily fluid and tissue samples obtained from Hematopoietic Cell Transplant (HCT) or novel immunotherapy patients and their donors at the Masonic Cancer Center in order to conduct correlative studies of the immune system, microbiota, and their interactions. Fluid (including but not limited to, blood, urine, saliva, cerebrospinal fluid, bronchoalveolar lavage fluid) sample log-in, processing, relabeling, and storage is performed by the Masonic Cancer Center (MCC) Translational Therapy Lab (TTL).

NCT ID: NCT03549676 Not yet recruiting - Clinical trials for Fecal Microbiota Transplantation in GVHD

Fecal Microbiota Transplantation for Treatment of Refractory Graft Versus Host Disease-a Pilot Study

Start date: July 1, 2019
Phase: Phase 1
Study type: Interventional

The study evaluates safety and efficacy of fecal microbiota transplantation (FMT) for the treatment of refractory graft-versus-host-disease (GVHD) of the gut. FMT might be a beneficial treatment in this clinical situation with a poor prognosis and limited therapeutic options.

NCT ID: NCT03546556 Terminated - Clinical trials for Graft Vs Host Disease

18-FLT PET/MR Imaging to Predict Graft Failure and GVHD in Bone Marrow Transplant Patients

Start date: January 1, 2017
Phase: Early Phase 1
Study type: Interventional

Allogeneic HSCT is potentially curative for numerous high risk hematologic malignancies and offers several advantages over traditional chemotherapy. First, higher doses of cytotoxic chemotherapy and/or irradiation can be given since patients are subsequently rescued from the severe myelosuppression induced by the pre-transplant conditioning regimen by the infusion of healthy hematopoietic stem cells. Second and perhaps more importantly, mature T cells contained in the graft are able to mount immune responses against residual cancer cells surviving the conditioning regimen due to major and/or minor MHC disparities between the donor and recipient. Unfortunately, the allo-immune responses driving the GVL effect are typically not specific for malignant cells. As a consequence, donor immune cells attack normal host tissues resulting in a process known as acute graft-versus-host disease (GVHD). Acute GVHD is primarily T cell driven, usually occurs within the first few months after transplant, and results in skin rash, diarrhea, cholestatic liver damage, and, on occasion, acute lung injury.

NCT ID: NCT03497273 Completed - Clinical trials for Acute Graft-versus-host Disease

Safety of Itacitinib in Combination With Corticosteroids for Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese Subjects

Start date: March 20, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of itacitinib in combination with corticosteroids in Japanese subjects with Grades II to IV acute graft-versus-host disease (aGVHD).

NCT ID: NCT03492502 Withdrawn - Clinical trials for Fecal Microbiota Transplantation in Graft vs. Host Disease

Autologous Fecal Microbiota Transplantation for Patients With Acute Graft-versus-Host Disease

Start date: August 1, 2019
Phase: N/A
Study type: Interventional

This study aims to assess the safety and efficacy of autologous fecal microbiota transplantation (FMT) in gastrointestinal (GI) related graft-versus-host disease (GVHD). Stool for FMT will be prepared from pre-allogeneic stem cell transplantation (Allo-SCT) period. This strategy might offer a novel and safe therapeutic approach for these patients, who suffer from high disease related morbidity and mortality and are refractory to multiple treatments.

NCT ID: NCT03491215 Completed - Clinical trials for Acute Graft Versus Host Disease

Study of Pharmacokinetics, Activity and Safety of Ruxolitinib in Pediatric Patients With Grade II-IV Acute Graft vs. Host Disease

Start date: February 21, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The study is an open-label, single-arm, Phase I/II multi-center study to investigate the PK, activity and safety of ruxolitinib added to the patient's immunosuppressive regimen in infants, children, and adolescents ages ≥28 days to <18 years old with either grade II-IV aGvHD or grade II-IV SR-aGvHD. The trial design includes four age groups: Group 1 includes patients ≥12y to <18y, Group 2 includes patients ≥6y to <12y, Group 3 includes patients ≥2y to <6y, and Group 4 includes patients ≥28days to <2y.

NCT ID: NCT03483675 Completed - Clinical trials for Chronic Graft Versus Host Disease

Discontinuation or Continuation of Immunosuppressive Therapy in Participants With Chronic Graft Versus Host Disease

Start date: June 6, 2018
Phase: Phase 2
Study type: Interventional

This randomized trial studies how well discontinuation or continuation of immunosuppressive therapy works in treating participants with chronic graft versus host disease. Continuation of immunosuppressive treatment may prevent graft-versus-host disease worsening.

NCT ID: NCT03474679 Completed - Clinical trials for Graft vs Host Disease

A Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Participants With Steroid Dependent/Refractory Chronic Graft Versus Host Disease (cGVHD)

Start date: May 1, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate efficacy of ibrutinib in Japanese participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall cGVHD response (complete response [CR] and partial response [PR] defined by National Institutes of Health [NIH] consensus development project criteria [2014]).