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Graft vs Host Disease clinical trials

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NCT ID: NCT01788501 Completed - Clinical trials for Graft vs Host Disease

Tacrolimus/Methotrexate Versus Cyclosporine/Methotrexate for Prophylaxis of Graft Versus Host Disease

Start date: November 2011
Phase: Phase 2/Phase 3
Study type: Interventional

This study aims to compare efficacy and safety of tacrolimus/methotrexate with cyclosporine/methotrexate for graft versus host disease prophylaxis in paediatric allogeneic hematopoietic stem cell transplantation patients.

NCT ID: NCT01758250 Completed - Sickle Cell Disease Clinical Trials

Microvascular and Fibrosis Imaging Study

Start date: February 2013
Phase:
Study type: Observational

In this study, Laser Doppler Flowmetry (LDF), Laser Doppler Imaging (LDI), Orthogonal Polarization Spectral Imaging (OPSI), Nail fold video capillaroscopy (NVC) and Optical Coherence Tomography (OCT) will be used to assess differences in microvascular function and density of oral mucosa and skin in subjects with 1) autoimmune diseases with cutaneous involvement: systemic sclerosis (SSc), morphea, dermatomyositis, cutaneous lupus and vasculitis, 2) sickle cell disease (SCD) and 3) chronic graft-versus-host disease (GVHD) compared to healthy subjects. The microvascular changes will be compared to overall treatment response in patients with scleroderma and chronic GVHD as assessments will be made before and after the patients start treatment for their diseases and determine if these imaging techniques provide valuable and reproducible data when assessing a patient's response to treatment for those diseases. In addition, the application of Acoustic Radiation Force Impulse (ARFI) in determining cutaneous thickness in patients with SSc, GVHD and morphea will be evaluated. The investigators hypothesize that the vascular and dermal structures are altered in patients with autoimmune disease, SCD and chronic GVHD. In addition, they hypothesize that imaging modalities such as LDF, LDI, OCT, NVC, OPSI and ARFI can quantify such structural alterations and can be used to 1) detect early disease activity, 2) quantify and assess response to therapy and 3) quantify and correlate with overall disease activity.

NCT ID: NCT01713400 Completed - Clinical trials for Graft vs. Host Disease

Tacrolimus, Sirolimus and Ustekinumab vs. Tacrolimus and Sirolimus for the Prevention of Acute Graft-Versus-Host Disease

Ustekinumab
Start date: February 25, 2013
Phase: Phase 2
Study type: Interventional

To determine whether treatment with ustekinumab will alter the ratio of T Regulatory Cell (Treg)/total cluster of differentiation 4 (CD4)+ cells in peripheral blood at day 30 post-hematopoietic cell transplantation (HCT).

NCT ID: NCT01700036 Completed - Clinical trials for Graft vs Host Disease

A Pilot Study of Alpha-1-Antitrypsin (AAT) in Steroid Refractory Acute Graft vs Host Disease

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

This clinical trial will study the safety and efficacy of using the drug Zemaira, an Alpha 1-Antitrypsin (AAT) medication (also known as an Alpha1-Proteinase Inhibitor [Human]) for the treatment of steroid refractory GVHD. For bone marrow transplant patients, the most common, serious complication is Graft vs Host Disease (GVHD), which at its most severe is a life-threatening, complication and a significant cause of treatment related death, following stem cell transplantation. GVHD is a major obstacle to the overall success of transplant treatment, a strategy that would otherwise provide the possibility of a cure for patients with blood cancers or severe blood disorders. GVHD primarily affects the skin, gut, and liver of the recipient, and involves the interaction of the recipient's (the host's) cells and tissues with the donor's immune system cells that see the host tissues as foreign, and attack the host's cells resulting in tissue and organ damage. The severity of acute GvHD ranges from mild to severe, and for patients who don't respond to steroid therapy, the complication is nearly always fatal, either from organ damage or opportunistic infection as a consequence of high dose, steroid treatments. There is currently no known effective therapy for patients with acute graft vs host disease that's refractory (nonresponsive) to steroid therapy. As stated earlier,the overwhelming majority of these patients may ultimately die from infection. The incidence of acute GvHD that requires intervention, is higher for unrelated donor transplants, the most common treatment option available, and therefore, these patients are at higher risk for treatment related complications from GVHD. Approximately 20,000 unrelated donor transplants are performed each year. The magnitude of this problem then is significant for patients who otherwise might be cured of their blood cancer or disease.

NCT ID: NCT01699412 Completed - Clinical trials for Graft vs Host Disease

Clinical Trial With Clobetasol and Dexamethasone for Topical Treatment of Oral Lesions of Chronic Graft-versus-host Disease

Start date: August 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to perform a randomized, double-blind, clinical trial comparing the topical treatment with clobetasol or dexamethasone for symptomatic oral lesions of chronic graft-versus-host disease.

NCT ID: NCT01695668 Completed - Dry Eyes Clinical Trials

Treatment of Ocular Graft-versus-Host Disease (GVHD) With Topical Loteprednol Etabonate 0.5%

Lotemax_BMT
Start date: August 2011
Phase: N/A
Study type: Interventional

The purpose of this research is to: 1. Evaluate the safety and efficacy of a steroid eye drop (Lotemax) in patients who have been diagnosed with graft-versus-host disease (GVHD), which is a complication that may occur after bone marrow transplant where the newly transplanted material attacks the patient's body and may cause eye dryness. 2. Assess the safety and efficacy of Lotemax in decreasing the eye's reaction to the process in GVHD before the patient undergoes bone marrow transplant. 3. Compare how well Lotemax works in decreasing the process in GVHD with an immunosuppressive eye drop (Restasis), which has been commonly used in the treatment of this condition.

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: NCT01680965 Completed - Clinical trials for Chronic Graft Versus Host Disease

Ofatumumab as Primary Therapy of Chronic Graft Versus Host Disease

Start date: November 14, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

To study the safety and side effects of Ofatumumab in the treatment of chronic graft-versus-host disease (GvHD). This study will also evaluate effectiveness of Ofatumumab when added to standard steroid treatment for chronic graft-versus-host disease

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: NCT01665677 Completed - Clinical trials for Graft vs Host Disease

Atorvastatin as GVHD Prophylaxis for Allogeneic Hematopoietic Cell Transplantation

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

Hematopoietic stem cell transplantation is a procedure in which a person receives blood forming stem cells from a person called a "donor." The stem cells can be obtained from the hollow part of the hip bone or from blood. A serious problem with this treatment is graft-versus-host disease (GVHD). This happens when stem cells from the donor attack normal cells of the recipient. Currently, there is no universal standard of care in the United States to prevent GVHD. This study is being done to see if a medicine that is used to lower cholesterol can also help in reducing GVHD. Patients will receive atorvastatin daily by mouth starting 14 days before stem cell transplant. They will continue to take atorvastatin until 180 days after transplant. This medicine may be stopped earlier if there is a bad side effect or a severe GVHD. Patients will also receive standard treatment to prevent GVHD. Patients will undergo many tests that are standard for their treatment at West Virginia University (WVU), including blood tests to check blood counts, kidney function and HIV status; blood test to check for pregnancy; Multi Gated Acquisition Scan (MUGA scan)or echocardiogram to test heart function; lung function testing; and bone marrow aspirate or biopsy. Patients will also have the option to provide blood samples for optional research related to the study.