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Graft vs Host Disease clinical trials

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NCT ID: NCT02669251 Recruiting - Clinical trials for Chronic Graft-Versus-Host Disease

Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation

Start date: April 28, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Bronchiolitis obliterans syndrome (BOS) is a complication people can experience after hematopoietic stem cell transplant. It usually affects people with chronic graft versus host disease (cGVHD). This occurs when donor stem cells attack the cells of the person who received them. BOS reduces airflow and oxygen levels in the body. It may be caused by neutrophil elastase in the body. Researchers believe the new drug alvelestat (MPH966) may help. Objectives: To test the safety of alvelestat (MPH966) and see what dose best inhibits neutrophil elastase in people with BOS after a stem cell transplant. To study how well the best dose improves lung function in those people. Eligibility: Adults 18 and older who have had a hematopoietic stem cell transplant and have cGVHD and BOS. Design: Participants will be screened with a medical history, physical exam, and blood and urine tests. They will have lung function and heart function tests. They will have computed tomography scans of the chest. Study part 1: Participants will take the starting dose of the study drug by mouth twice a day for 14 days. This is 1 cycle. They will get different doses, for up to 4 cycles. Study part 2: Participants will take the study drug twice a day by mouth at the dose set in part 1, for up to 12 months. Participants will keep medicine diaries. Participants will have several study visits. These may include: Repeats of the screening tests. Bronchoscopy with bronchoalveolar lavage. Sputum samples taken. 6-minute walking test. cGVHD assessment and answer questions. Participants will be contacted after the study for up to 24 months.

NCT ID: NCT02659657 Recruiting - Clinical trials for Acute Graft-versus-host Disease

Prophylaxis Roles of IL-2 Treatment on GVHD After Transplantation

Start date: March 2015
Phase: Phase 2
Study type: Interventional

The effects of haploidentical rhG-CSF-mobilized unmanipulated blood and marrow transplantation (HBMT) on hematological malignancies are well established.The aim of this prospective cohort trial is to determine if acute graft-versus-host disease (aGVHD) could be decreased with IL2 therapy post HBMT.

NCT ID: NCT02643589 Recruiting - Clinical trials for Hematopoietic Stem Cell Transplantation

Dose Study of Antithymocyteglobulin in Haploidentical Allogeneic Stem Cell Transplantation

Start date: June 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the incidences of GVHD in haploidentical hematopoietic stem cell transplant recipients receiving different dose of antithymocyte globulin (ATG) for acute graft-versus-host disease(aGVHD) prophylaxis. The investigators' first objective was to investigate the optimal dose of ATG for aGVHD.

NCT ID: NCT02611180 Recruiting - Clinical trials for Chronic Graft-versus-host Disease

Dendritic Cells in Patients With Acute or Chronic Skin Graft Versus Host Disease

Start date: April 30, 2015
Phase:
Study type: Observational

Dendritic cells (DCs) serve as sentries for the immune system. DCs recognize foreign compounds (antigens) in the body, which they internalize and process. When DCs uptake foreign antigens, they migrate to secondary lymphoid organs, where the processed antigens are presented to T cells. Various DC subsets with unique cell lineages, surface protein markers, and tissue localization determinants have been identified. For example, Langerhans cells (LCs) and interstitial dendritic cells (intDCs) are DCs found in stratified epithelia, such as the skin. Though both are expressed in the skin, they differ with respect to their origin and surface protein content and can activate distinct types of immune responses. They may also have different specificities for the capture of antigens and presentation to circulating T cells. To date, it is unknown what role, if any, the different DC populations that reside or repopulate in the skin play in the development and progression of skin graft-versus-host disease (GVHD) following bone marrow transplant.

NCT ID: NCT02386800 Recruiting - Clinical trials for Acute Myeloid Leukemia

CINC424A2X01B Rollover Protocol

Start date: March 5, 2015
Phase: Phase 4
Study type: Interventional

This is a long term safety study for patients that have been treated with either ruxolitinib or a combination of ruxolitinib with panobinostat, on a Novartis or Incyte sponsored study, who have been judged by the study Investigator to benefit from ongoing treatment.

NCT ID: NCT02385019 Recruiting - Clinical trials for Graft vs Host Disease

A Phase 1/2 Trial of Donor Regulatory T-cells for Steroid-Refractory Chronic Graft-versus-Host-Disease

TREGeneration
Start date: March 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Phase 1/2 clinical study for the treatment of steroid-refractory chronic graft versus host disease after an allogeneic transplant of hematopoietic progenitors with donor CliniMACS-selected regulatory T cells

NCT ID: NCT02352064 Recruiting - Clinical trials for Chronic Graft Versus Host Disease

Evaluation of the Diagnostic Value of PET (18F-FDG) in Chronic Graft Versus Host Disease (cGVH)

TEP-GVH
Start date: January 2015
Phase: N/A
Study type: Interventional

Allogeneic stem cell transplantation was developed to cure many patients with hematological malignancies. It results in the development of graft versus host disease (GVHD) in 30-70% of cases. Chronic GVHD diagnosis currently uses biopsies of affected organs (skin, liver, gastrointestinal tract) and / or the observation of typical clinical signs sufficient for diagnosis. However, the anatomical sites for biopsy including the digestive tract are not clearly identified (high or low biopsy) and may present risks in their realization in particular in patients weakened by blood disease or immunosuppression. PET-CT with 18F-FDG has already been evaluated in chronic inflammatory diseases such as Crohns disease with good sensitivity and specificity. It interest in the graft against the host was studied in acute forms of digestive and allows lesion mapping and monitoring the effectiveness of treatment. Among patients with chronic GVHD scleroderma form, PET with 18F-FDG enabled to view musculoskeletal uptakes localized to the affected areas identified with MRI. The investigators propose a study evaluating the sensitivity and specificity of the examination by PET-CT with 18F-FDG in the diagnosis of chronic GVHD compared to conventional diagnostic tools.

NCT ID: NCT02342145 Recruiting - Clinical trials for Beta-Thalassemia Major

Efficacy of Basiliximab in the Prevention of Acute Graft-versus-host Disease in Unrelated Allogeneic Hematopoietic Stem Cell Transplantation Therapy for Thalassemia Major

Start date: June 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the basiliximab for prevention of graft-versus-host disease in unrelated allo-genetic hematopoietic stem cell transplantation for thalassemia major. The objective was to evaluate the effect and safety of basiliximab for acute graft-versus-host disease.

NCT ID: NCT02337595 Recruiting - Clinical trials for Leukemia, Myeloid, Acute

Memory T-cell Infusion to Improve Immunity After TCR-alpha/Beta Depleted Hematopoietic Stem Cell Transplantation

45RA_NEG_DLI
Start date: August 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The stud will evaluate whether infusions of CD45RA-depleted lymphocytes from the donor early post-transplant is a safe way to improve immunity to common infections in recipients of TCR-alpha/beta depleted hematopoietic stem cell grafts.

NCT ID: NCT02300571 Recruiting - Clinical trials for Hematological Malignancies

Observational Study of the Combination of Post-transplant High Dose Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Acute Graft-versus-Host Disease in Patients Eligible to Allogeneic Hematopoietic Stem Cell Transplant

Start date: September 2013
Phase: N/A
Study type: Observational

This observational study is proposed to observe the effect of high-dose, post-transplantation cyclophosphamide after a T cell-replete, HLA-matched PBSC graft from an HLA-identical or mismatched donor.