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Graft vs Host Disease clinical trials

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NCT ID: NCT01699516 Recruiting - Clinical trials for Neutropenic Enterocolitis

Non-invasive Contrast Enhanced Ultrasound Sonography in Intestinal Acute Graft-vs-Host Disease

Start date: January 2008
Phase: N/A
Study type: Observational

Intestinal acute graft-vs-host disease (GVHD) is a life-threatening complication after allogeneic hematopoietic cell transplantation. Non-invasive diagnostic procedures are still lacking and diagnosis is difficult. We hypothesized that contrast-enhanced ultrasound sonography (CEUS) could detect microcirculation changes of the bowel walls during intestinal GVHD and help to detect and monitor treatment response. We employed CEUS to prospectively evaluate intestinal GVHD in 83 consecutive transplant patients between 2008 and 2011. Fourteen /83 patients with biopsy-proven intestinal GVHD were selected as study group. Fourteen patients with biopsy-proven stomach GVHD without intestinal symptoms (N=16), normal volunteers (N=6) and patients with neutropenic enterocolitis (N=4), were chosen as control group. All patients were evaluated with both standard transabdominal ultrasonography (US) and CEUS at the onset of intestinal symptoms, during clinical follow up and at flare of symptoms. Standard US revealed non-specific bowel wall thickening, and simultaneous involvement of multiple intestinal segments in 9/14 patients. CEUS showed three distinct patterns of microcirculation changes that correlated with GVHD activity. These findings were not observed in the control group. Moreover, CEUS findings correlated with treatment response and predicted flare of intestinal symptoms. CEUS is a non-invasive, easily reproducible bed-side tool to detect and monitor intestinal GVHD.

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.

NCT ID: NCT01663766 Terminated - Clinical trials for Myelodysplastic Syndrome

Phase I Study of Milatuzumab for Graft Versus Host Disease

Start date: December 2013
Phase: Phase 1
Study type: Interventional

This study will assess the safety and tolerability of milatuzumab (IMMU-115) when added to a standard regimen to prevent Graft vs. Host Disease (GVHD) in patients with hematologic malignancies undergoing stem cell transplant.

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: NCT01616680 Withdrawn - Clinical trials for Graft Versus Host Disease

Brentuximab Vedotin in Treating Patients With Steroid-Resistant Acute Graft-Versus-Host Disease

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

The purpose of this research is to test the safety and efficacy of brentuximab vedotin in patients with acute skin graft-versus-host disease (GVHD)