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Graft Versus Host Disease clinical trials

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NCT ID: NCT03591874 Terminated - Clinical trials for Graft Versus Host Disease

Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease

oGVHD
Start date: December 23, 2018
Phase: Phase 3
Study type: Interventional

This study evaluates the use of Brimonidine tartrate nanoemulsion eye drop solution in the treatment of ocular Graft Verses Host Disease (oGVHD). Two thirds of participants will receive Brimonidine and one third will receive ophthalmic buffered saline (placebo).

NCT ID: NCT03395340 Terminated - Clinical trials for Graft Versus Host Disease

Topical Ruxolitinib for Cutaneous Chronic Graft Versus Host Disease (cGVHD)

Start date: November 19, 2018
Phase: Phase 2
Study type: Interventional

Background: About half the people who have a hematopoietic stem cell transplant using donor cells get Chronic Graft Versus Host Disease (cGVHD). This is chronic graft versus host disease. Immune cells from the donor may see the body tissues in the person as foreign and attack, causing damage. The skin is the most commonly affected organ. Most cGVHD therapies have serious side effects. The cream ruxolitinib inhibits proteins that may play a role in cGVHD. Objective: To test the safety and effectiveness of topical ruxolitinib 1.5 percent cream in people with cGVHD of the skin. Eligibility: People ages 12 and older with epidermal skin cGVHD Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Skin sample taken (biopsy) to confirm the diagnosis. At the baseline visit, participants will have: Skin disease measured with rulers, photographs, and tracing the outline of skin lesions To complete questionnaires about their symptoms Blood and urine tests Some participants will also have a skin biopsy, or total body photographs while they wear only underwear. Participants will get the ruxolitinib cream and a placebo cream to apply to 2 separate areas of disease. They will do this twice a day for 6 weeks, if they do not have serious side effects. Neither the study team nor the participant will know which area will get ruxolitinib cream and the placebo cream. Participants will write down: - When they apply the creams - Any side effects - Any medications they take Most participants will have 4 visits during the 6 weeks they use the creams. Some will have 3 visits and a phone call to see how they are doing. All participants will get a call 4-6 weeks after they stop. Visits include physical exams, blood tests, skin disease measurements, questionnaires, and photos.

NCT ID: NCT03263767 Terminated - Clinical trials for Graft Versus Host Disease

Post Transplant Cyclophosphamide (PTCY) as Sole Graft Versus Host Disease (GVHD) Prophylaxis for Matched Allotransplant: CYRIC

CYRIC
Start date: January 15, 2018
Phase: Phase 2
Study type: Interventional

Acute or chronic graft versus host disease is still the major complication of stem cells transplantation regarding morbidity and mortality. Recently, high dose cyclophosphamide utilization early after post-transplantation (day+ 3 and +4) not only for patients with HLA- haploidentical donor but also for patients with Human Leukocyte Antigen (HLA)-compatible donor, showed a great control of graft versus host disease after transplantation, allowing to consider stopping immunosuppressive treatment after the transplantation (Neoral=cyclosporine, cell-cept=mycophenolate mofetil). Indeed, this step has already been completed in myeloablative transplantation in adult patients. This approach could enable to avoid in the end several complications related to long term immunosuppressive drugs administration, while promoting quicker immunity recovery.

NCT ID: NCT03102060 Terminated - Clinical trials for Graft Versus Host Disease

Gluten Free Diet in Preventing Graft Versus Host Disease in Patients Undergoing Donor Stem Cell Transplant

Start date: August 22, 2017
Phase: N/A
Study type: Interventional

This pilot clinical trial studies how well a gluten free diet works in preventing graft versus host disease in patients who are undergoing a donor stem cell transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft versus host disease). A gluten free diet may decrease intestinal inflammation and graft versus host disease in patients who are undergoing a donor stem cell transplant.

NCT ID: NCT02976558 Terminated - Depression Clinical Trials

The Influence of TaKeTiNa Music Therapy, Traditional Chinese Acupuncture and Clown Theatrical Performance on Quality of Life and the Therapeutic Process of Patients Undergoing Allogenic Stem Cell Transplantation

TriCAM
Start date: December 2016
Phase: N/A
Study type: Interventional

The allogenic stem cell transplantation (aSCT), the only curative approach for many hematological diseases, often leads to severe diseases or chronic conditions, leaving patients with physical disabilities and severe depression and impacting their quality of life in many cases. These consequences are still not adequately addressed by conventional therapies. In this study, the investigators examine the influence of the three complementary medicine methods (CAM) namely acupuncture according to Traditional Chinese Medicine (TCM), music therapy according to the TaKeTiNa method and the psychological disease processing by theatrical clown performance on the quality of life and the therapy process of patients before and after aSCT.

NCT ID: NCT02956122 Terminated - Clinical trials for Graft Versus Host Disease

A Phase 2/3 Study of GLASSIA for the Treatment of Acute GvHD

Start date: April 26, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of the study is to evaluate the safety and efficacy of GLASSIA as an add-on biopharmacotherapy to standard-of-care steroid treatment as the first-line treatment in participants with acute GvHD with lower GI involvement.

NCT ID: NCT02877082 Terminated - Clinical trials for Chronic Lymphocytic Leukemia

Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients

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

This phase II trial studies how well tacrolimus, bortezomib, and anti-thymocyte globulin (thymoglobulin) work in preventing low toxicity graft versus host disease (GVHD) in patients with blood cancer who are undergoing donor stem cell transplant. Tacrolimus and anti-thymocyte globulin may reduce the risk of the recipient's body rejecting the transplant by suppressing the recipient's immune system. Giving bortezomib after the transplant may help prevent GVHD by stopping the donor's cells from attacking the recipient. Giving tacrolimus, bortezomib, and anti-thymocyte globulin may be a better way to prevent low toxicity GVHD in patients with blood cancer undergoing donor stem cell transplant.

NCT ID: NCT02379442 Terminated - Clinical trials for Graft-Versus-Host Disease

Early Treatment of Acute Graft Versus Host Disease With Bone Marrow-Derived Mesenchymal Stem Cells and Corticosteroids

Start date: February 23, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - Sometimes after stem cells are transplanted, donor cells attack the recipient s cells and cause tissue damage. This is called acute graft-versus-host-disease (GVHD). Researchers want to see if bone marrow-derived mesenchymal stem cells (BMSC) can help treat GVHD. BMSC can travel in the body and help repair tissue. The BMSC in this study were grown from bone marrow from healthy volunteers. Objectives: - To test whether BMSC are safe to use soon after GVHD is diagnosed and to see how the body s immune system responds to BMSC. Eligibility: - People over 4 years old who had a stem cell transplant at NIH and now have acute GVHD. People who have had certain previous immunosuppressive therapy may be ineligible. Design: - Participants will be screened with medical history, physical exam, and blood tests. They will have a GVHD exam, including skin and stool tests. They must have a functioning central line. - Participation will last 11 weeks: 4 8 weeks of cell infusions, then follow-up for the rest of the weeks. - Up to 12 cell infusions: - Participants will come to the clinic twice weekly. - They will get medicine to prevent side effects (like Tylenol and Benadryl). - BMSC will be given through a small plastic tube in an arm vein or through an IV catheter. It will last 20 60 minutes. - Participants will be monitored for 1 hour. - Follow-up visits: Up to twice a week, participants will have physical exam and blood tests. They may have a GVHD exam. - Participants who have a tissue biopsy outside the study will be asked to send a sample to the study.

NCT ID: NCT02322190 Terminated - Clinical trials for Graft vs Host Disease

Biomarkers in Acute Graft-Versus-Host Disease and Extracorporeal Photopheresis Added to Investigator Chosen Therapies of Steroid Refractory Acute GVHD

Start date: December 20, 2014
Phase: Phase 2
Study type: Interventional

Background: - Some allogeneic stem cell transplant recipients get acute graft-versus-host disease (GVHD). They always get steroids as the first treatment, but this may not work. Those people where steroids are not enough may benefit from a treatment called extracorporeal photopheresis (ECP). ECP exposes white blood cells to ultraviolet light outside the body. Researchers want to study how certain markers in the blood predict the severity and outcome of acute GVHD and how ECP treatments work for people with acute GVHD. They will also study how these markers in the blood may help predict who should get ECP and its effects on the immune system. Objectives: - To learn more about treatments for acute GVHD after allogeneic stem cell transplantation. Eligibility: - Adults with acute GVHD enrolled in an National Cancer Institute (NCI) allogeneic transplantation protocol. Design: - Transplant physicians will confirm participant eligibility. - Participants will receive treatment with steroids for their acute GVHD as prescribed by their transplant physician. This will continue while they are enrolled on this study. - If steroids work in treating their acute GVHD, then every 28 days for 6 months, participants will have: - a physical exam. - blood tests. - If steroids do not work, participants will get additional treatments as prescribed by their transplant physician who may choose to use ECP as a part of this additional treatment. For ECP, blood is removed through an intravenous (IV) catheter. A machine separates the white blood cells from the other blood parts. Those cells are treated with methoxsalen and exposed to ultraviolet light. Then they are returned to the participant through their IV. - Participants who get ECP will over at least 6 months have: - veins researched. They may have a catheter placed in a larger vein in the chest or groin. - multiple blood tests. - multiple pregnancy tests (if needed). - multiple ECP procedures. - At the end of ECP treatment and 6 months after ECP, participants will have additional physical exams and blood tests.

NCT ID: NCT02203578 Terminated - Clinical trials for Graft Versus Host Disease

Romidepsin in Treating Patients With Steroid-Refractory Graft-versus-Host Disease

Start date: November 2014
Phase: N/A
Study type: Interventional

This pilot clinical trial studies romidepsin in treating patients with graft-versus-host disease (GVHD) that has not responded to treatment with steroids. Romidepsin may be an effective treatment for graft-versus-host disease caused by a bone marrow or stem cell transplant.