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A Study To Evaluate The Safety And Efficacy Of Axatilimab In Combination With Ruxolitinib In Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD.
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A Study to Investigate the Implications of Loss of Gut Microbiota Diversity and Long-term Clinical Outcomes in alloHSCT Recipients
Jacksonville, FL
In this study we seek to investigate the implications of loss of gut microbiota diversity by correlating them with long-term clinical outcomes in alloHSCT recipients.
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Evaluation Of The AMICUS Extracorporeal Photopheresis (ECP) System In Patients With Chronic Graft Versus Host Disease
Rochester, MN
The purpose of this study is to evaluate the inhibition of lymphocyte proliferation in ECP treated MNC samples obtained from cGVHD subjects treated with the AMICUS ECP System.
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A Phase 2/3 Study of GLASSIA for the Treatment of Acute GvHD
Jacksonville, FL
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.
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Axatilimab Plus Standard Of Care Therapy For The Prevention Of Graft Versus Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation In Patients With Hematologic Cancer, ABRAXAS Trial
Jacksonville, FL; Scottsdale/Phoenix, AZ; Rochester, MN
This phase II trial studies how well adding axatilimab to standard of care (SOC) therapy works in preventing graft versus host disease (GVHD) following allogeneic hematopoietic stem cell transplantation (HCT) in patients with hematologic cancer. Allogeneic HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical, donor. This is often a sister or brother, but could be an unrelated donor. Sometimes the transplanted cells from a donor can attack the body's normal cells, causing GVHD. Symptoms of GVHD can include yellowing of the skin, ...
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Diagnostic and Prognostic Validity of Tissue-based Biomarker Assay for Acute Graft-versus-host Disease of the Skin: A Retrospective Study
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to validate the diagnostic and prognostic utility of our tissue-based assay, the aim is to perform a multi-institution, retrospective study of our assay compared with the current clinical gold standard (clinicopathologic correlation and prospective observation of clinical course, respectively).
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Study Of Brimonidine Tartrate Nanoemulsion Eye Drops In Patients With Ocular Graft-vs-Host Disease
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate 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).
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GRAVITAS-301: A Study Of Itacitinib Or Placebo In Combination With Corticosteroids For Treatment Of Acute Graft-Versus-Host Disease
Rochester, MN
The purpose of this study is to evaluate itacitinib or placebo in combination with corticosteroids as first-line treatment of participants with Grade II to IV acute graft-versus-host disease (aGVHD).
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A Study Of Axatilimab At 3 Different Doses In Patients With Chronic Graft Versus Host Disease (CGVHD)
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess SNDX-6352, or Axatilimab, for individuals who have active chronic recurrent or refractory Graft versus Host Disease (cGVHD) whom have used at least two previous treatments and have not had an improvement in symptoms. This study evaluates the effectiveness, safety, and tolerability of axatilimab at three different dose levels. Participants can receive axatilimab for up to two years and could be in the study up to 28 months.
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Intense Pulsed Light (IPL) and Meibomian Gland Expression to Treat Ocular Rosacea Secondary to Inactive Chronic Ocular GVHD
Scottsdale/Phoenix, AZ
Is Intense Pulsed Light (IPL) treatment and eyelid meibomian gland manual expression safe and effective for allogeneic stem cell transplant patients with ocular rosacea in the setting of quiescent graft-versus-host disease?
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International Chronic Ocular Graft-vs-Host Disease (GVHD) Consensus Group: Proposal Of New Diagnostic Criteria For Chronic GVHD
Scottsdale/Phoenix, AZ
The aim of this multicenter study is to prospectively collect anonymous data at international cancer centers from eye exams after development of dry eye symptoms and ocular GVHD in patients status post stem cell transplant for hematological disorders.
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A Study Of Itolizumab In Combination With Corticosteroids For The First-Line Treatment Of Acute Graft Versus Host Disease (EQUATOR)
Rochester, MN
The purpose of this study is to compare the effectiveness and safety of itolizumab versus placebo as first-line therapy for subjects with Grade III-IV aGVHD or Grade II with LGI involvement, in combination with corticosteroids.
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A Study To Determine The Effects Of COVID-19 In Cancer Patients
Scottsdale/Phoenix, AZ; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The study aims to characterize patient factors, such as pre-existing comorbidities, cancer type and treatment, and demographic factors, associated with short- and long-term outcomes of COVID-19, including severity and fatality, in cancer patients undergoing treatment. The study also is aimed to describe cancer treatment modifications made in response to COVID-19, including dose adjustments, changes in symptom management, or temporary or permanent cessation. Lastely, evaluate the association of COVID-19 with cancer outcomes in patient subgroups defined by clinico-pathologic characteristics.