Clinical Trials

Acute Graft-versus-Host-Disease (GVHD) is an important cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation (HSCT). This study aims to determine if any of three new GVHD prophylaxis approaches improves the rate of GVHD and relapse free survival at one year after transplant compared to the current standard prophylaxis regimen.

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.

The purpose of this study is to assess the safety and effectiveness of combining the study drug Natalizumab (Tysabri®) with the standard use of steroid treatment, as a new treatment for acute graft versus host disease (acute GVHD). GVHD is the most common serious complication, after bone marrow transplant. GVHD occurs when the donor cells (the graft), treat the recipient's body as "foreign" and attack the cells in the recipient's body. During this immune system response, donor cells damage body tissues, such as the skin, liver, stomach, and/or intestines. Acute GVHD can be severe and potentially fatal to the transplant recipient.

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.

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

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).

The purpose of this study is to determine if INCB039110 in combination with corticosteroids is safe and tolerable for treating patients with Grade IIB-IVD acute graft-versus-host disease (GVHD).

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.

The primary purpose of this study is to demonstrate the feasibility of sublingual (SL) administration of tacrolimus in blood and marrow transplant (BMT) patients.

The purpose of this study is to identify an optimal dose for GDC-8264 for future studies, using all available safety, pharmacokinetic, and effectiveness data.

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). 

Samples of blood and urine will be analyzed for biomarkers to check their predictivity of Graft-versus-Host Disease (GVHD) outcomes.

The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of AMG 592 in subjects with steroid refractory cGVHD. Phase 2 - The purpose is to evaluate the effectiveness of AMG 592 in subjects with steroid refractory cGVHD as measured by ORR at 16 weeks according to the 2014 cGVHD NIH Consensus Criteria.

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.

The purpose of this study is to provide ruxolitinib through an expanded access program for the treatment of graft-versus-host disease (GVHD) in United States to patients who are ineligible or unable to participate in any actively enrolling Incyte-sponsored clinical studies for ruxolitinib in the treatment of GVHD.

The purpose of this study is to test whether patients with low risk Great-vs-Host Disease (GVHD) can be successfully treated without steroids. Patients who participate with this study will be treated with itacitinib instead of steroids. Itacitinib is an experimental drug with an excellent safety record and appears to have activity as a GVHD treatment. A new blood test can identify patients whose GVHD is most likely to respond to well to treatment (low risk GVHD).

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).

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.

The study is a Phase II randomized, open label, multicenter trial designed to identify whether sirolimus is a potential alternative to prednisone as an up-front treatment for patients with standard-risk acute GVHD defined according to clinical and biomarker-based risk stratification. This trial incorporates both a novel up front GVHD therapy (sirolimus) as well as a novel BMT CTN developed acute GVHD biomarker test.

The purpose of this study is to compare the defibrotide prophylaxis arm vs. standard of care arm for the prevention of aGvHD.

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.

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?

The purpose of this study is to evaluate the effectiveness of ibrutinib in reducing the incidence of NIH moderate/severe chronic GVHD.

The study is designed as a three arm randomized Phase III, multicenter trial comparing two calcineurin inhibitor (CNI)-free strategies for Graft-versus-Host Disease (GVHD) prophylaxis to standard tacrolimus and methotrexate (Tac/Mtx) in patients with hematologic malignancies undergoing myeloablative conditioning hematopoietic stem cell transplantation.

The purpose of this study is to evaluate the effectiveness of vedolizumab when added to background aGvHD prophylaxis regimen compared to placebo and background aGvHD prophylaxis regimen on intestinal aGvHD-free survival by Day +180 in participants who receive allo-HSCT as treatment for a hematologic malignancy or myeloproliferative disorder.

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and effectiveness of SER-155 in adults undergoing hematopoietic stem cell transplantation to reduce the risk of infection and graft vs. host disease.

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.

The purpose of this study is to provide ruxolitinib through an expanded access program in the United States for the treatment of graft-versus-host disease (GVHD) in patients who are ineligible or unable to participate in any actively enrolling Incyte-sponsored clinical studies for ruxolitinib in the treatment of GVHD.

The primary purpose of this study is to compare 1 year graft-versus-host disease (GVHD)-free, graft relapse-free survival (GRFS) between the two GVHD prophylaxis regimens.