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Graft Versus Host Disease clinical trials

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NCT ID: NCT01857336 Completed - Clinical trials for Graft Versus Host Disease

G-CSF Moblized Peripheral Harvest for Poor Engraftment After Stem Cell Transplantation

Start date: March 1, 2013
Phase: N/A
Study type: Interventional

Poor graft function (PGF) is a common complication after allogeneic stem cell transplantation, which was associated with high mortality. The pathogenesis fo PGF was poorly understood. Infusion of donor peripheral cell harvest was effective for some patients with PGF in our preliminary study. This present study aimed to explore the efficacy of peripheral cell harvest for poor graft function.

NCT ID: NCT01851382 Completed - Healthy Volunteer Clinical Trials

Collection of Saliva and/ or Peripheral Blood From Healthy Volunteers for Research

Start date: May 15, 2013
Phase:
Study type: Observational

Background: - Researchers often collect samples from healthy volunteers to further their research. These samples can help better understand serious side effects and complications of transplant treatments in patients. This study will collect saliva samples from healthy volunteers. Objectives: - To collect saliva and blood samples from healthy volunteers for research studies. Eligibility: - Healthy men ages 30-70 years for Phase I of the study. Design: - Participants will be screened with a medical history questionnaire. They will also have a brief oral exam to check for any mouth infection. - Participants will provide a saliva sample. The collection process will take about 5 minutes. - No treatment will be given as part of this study.

NCT ID: NCT01795573 Completed - Clinical trials for Graft Versus Host Disease

Ex-vivo Expanded Donor Regulatory T Cells for Prevention of Acute Graft-Versus-Host Disease

Start date: October 29, 2014
Phase: Phase 1
Study type: Interventional

Clinical trial of allospecific regulatory t cells (Tregs) for prevention of acute graft-versus-host disease (GVHD) in human leukocyte antigen (HLA) identical sibling transplants.

NCT ID: NCT01789255 Completed - Clinical trials for Chronic Myelomonocytic Leukemia

Vorinostat, Tacrolimus, and Methotrexate in Preventing GVHD After Stem Cell Transplant in Patients With Hematological Malignancies

Start date: June 2013
Phase: Phase 2
Study type: Interventional

This pilot phase II trial studies how well giving vorinostat, tacrolimus, and methotrexate works in preventing graft-versus-host disease (GVHD) after stem cell transplant in patients with hematological malignancies. Vorinostat, tacrolimus, and methotrexate may be an effective treatment for GVHD caused by a bone marrow transplant.

NCT ID: NCT01688466 Completed - Clinical trials for Graft vs Host Disease

Pomalidomide for Chronic Graft-versus-Host Disease

Start date: August 30, 2012
Phase: Phase 2
Study type: Interventional

Background: - Pomalidomide is a drug that alters the body's immune response. It may help people who have chronic graft-versus-host disease (GvHD). GvHD may appear after a stem cell transplant, when immune cells in the transplant try to attack tissues in the person who received the transplant. GvHD is not easy to treat, and often does not respond to standard treatments. Researchers want to see if pomalidomide is a safe and effective treatment for GvHD. Objectives: - To test the safety and effectiveness of pomalidomide for GvHD that has not responded to standard treatments. Eligibility: - Individuals at least 18 years of age who have GvHD that has not responded to standard treatments. Design: - Participants will be screened with a physical exam and medical history. Blood and urine samples will also be collected. A lung function test and imaging studies will also be given. - Participants will take pomalidomide capsules once a day for 4-week periods called cycles. - Treatment will be monitored with frequent blood tests and imaging studies. Saliva samples and skin and mouth tissue biopsies will also be collected during treatment. - Treatment will continue for six cycles (6 months), unless the GvHD gets worse or side effects are too severe. If the GvHD has improved at the end of the six cycles, participants may be able to continue to take pomalidomide for up to six more cycles.

NCT ID: NCT01672229 Completed - Clinical trials for Graft Versus Host Disease

Bortezomib in Patients With Chronic Graft Versus Host Disease

Start date: July 2012
Phase: Phase 1
Study type: Interventional

This study will investigate whether bortezomib can control the immune system and can be used to treat GVHD. Bortezomib has been used with not too many serious side effects in patients with multiple myeloma who will undergo transplant and also for acute graft versus host disease.

NCT ID: NCT01633229 Completed - Clinical trials for Graft-Versus-Host Disease

Bone Marrow Stromal Cell Infusions for Stem Cell Transplant Complications

Start date: November 14, 2011
Phase: Phase 1
Study type: Interventional

Background: - Bone marrow stromal cells (BMSC) from bone marrow biopsies can be used to treat disorders that cause inflammation and immune system diseases. BMSC have been used to treat graft versus host disease (GVHD), a complication that can develop after stem cell transplants. BMSC have also been used to treat other post-transplant complications, like marrow failure or tissue injury. - The National Institutes of Health (NIH) has developed a procedure for collecting and preserving BMSC from volunteer donors. These donors have passed tests to ensure that their cells are healthy enough to be used for treatment. Researchers want to use the collected cells to treat people with GVHD, marrow failure, or tissue injury following stem cell transplants. Objectives: - To test the safety and effectiveness of NIH-collected BMSC to treat complications from stem cell transplants. Eligibility: - Individuals between 18 and 75 years of age who have complications from stem cell transplants. - Complications are acute GVHD, poor bone marrow function, or tissue or organ damage. Design: - Participants will be screened with a physical exam and medical history. They will also have imaging studies and blood tests. - Participants will provide blood, skin, and bone marrow samples before the BMSC treatment. Additional samples, including tissue samples, will be collected after the start of treatment. - Participants will have up to three BMSC infusions. There will be a week between each infusion. Participants will be monitored closely during each infusion. Any side effects will be treated. - Treatment will be monitored with frequent blood tests and physical exams. - After the end of the infusions, participants will have regular followup visits for up to 2 years.

NCT ID: NCT01616056 Completed - Clinical trials for Graft Versus Host Disease

Bandage Lenses in Treating Patients With Ocular Graft-Versus-Host Disease

Start date: June 2012
Phase: Phase 2
Study type: Interventional

This phase II clinical trial studies how well bandage lenses work in treating patients with ocular graft versus host disease. Bandage lenses may be helpful in relieving eye symptoms and damage caused by eye graft versus host disease.

NCT ID: NCT01379209 Completed - Clinical trials for Graft Versus Host Disease

Intravenous Administration of RGI-2001 in Patient Undergoing Allogenic Hematopoietic Stem Cell Transplantation (AHSCT)

Start date: September 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The clinical trial is a Phase 1/2a, open-label, multi-center, dose-escalation study to evaluate the safety, tolerability and pharmacokinetic profile of RGI-2001 in patients undergoing AHSCT, with radiation or non-radiation myeloablative preparative treatment. The study will be separated into two parts; a dose escalation phase to assess safety, followed by a large expansion phase to further evaluate the pharmacologic effects of either a Maximum Tolerated Dose, Maximum Feasible Dose or optimal pharmacologically active dose of RGI-2001. The initial dose escalation safety portion of the study (Part 1) will include higher risk patients and limit the unrelated donor transplants. After safety is established in part 1 of the study, the second portion of the study will expand the enrollment criteria and allow transplantation by either related or unrelated donors. This study will endeavor to identify the dose range at which RGI-2001 has an acceptable safety profile, at which biologic activity is observed, and to guide possible dose levels to utilize in later phase studies based on biological activity.

NCT ID: NCT01369914 Completed - Clinical trials for Graft-Versus-Host Disease

The Natural History of Graft-Versus-Host Disease in the Eyes

Start date: May 20, 2011
Phase:
Study type: Observational

Background: - Stem cell transplantation (SCT) is used to treat some kinds of cancer, blood cell disorders, and immune disorders. Stem cells from a donor s blood are used to replace the recipient s stem cells in the bone marrow. The recipient s bone marrow can then produce new blood cells. Some of these new cells involved in the immune system are like the donor s cells. Sometimes immune cells from the SCT attack the recipient s normal tissues, including the eyes. This type of immune attack is called graft-versus-host disease, or GVHD. - The symptoms of ocular GVHD include eye pain, irritation, dryness, and inflammation. When it is severe and if it does not respond well to treatment, ocular GVHD may also cause vision loss. Objective: - To learn more about graft-versus-host disease (GVHD) of the eyes in people who have had stem cell transplantation. Eligibility: - Participants must be at least 18 years of age. - They must be taking part in a study at the National Cancer Institute (NCI) or the National Heart, Lung and Blood Institute (NHLBI). - They must have a SCT scheduled within the next 30 days. Design: - The study lasts for 1 year and includes six visits to the National Eye Institute. (There is an optional visit about 1 month before your SCT.) When possible, visits for this study will be scheduled so that they can be done on the same day as your visits for the NCI or NHLBI protocol that you are taking part in. - At each visit, participants will have a medical exam and an eye history will be taken. They will have an eye exam and a test to measure the ability to make tears. Those in the study will also have tear fluid collected for analysis in a lab. Tear fluid collection is a painless process. Blood will be drawn during certain visits if it has not already been collected by the transplant team.