Clinical Trials

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 collect pilot data to determine levels of physical activity (PA) among HCT patients and caregivers, and to assess hypothetical interest in a dyad-based, technology-enhanced PA intervention for HCT patients and caregivers.

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 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 the effects that psychological and health behavior factors have on quality of life, level if sickness, and death after blood and bone marrow transplantation.

The main objective of this study is to evaluate the effectiveness of venetoclax in combination with azacitidine to improve Relapse Free Survival (RFS) in AML patients compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation (SCT). This study will have 2 parts: Part 1 (Dose Confirmation), which may include participants who are greater than or equal to 18 years old; Part 2 (Randomization) which may include participants who are greater than or equal to 12 years old. During Part 1, recommended Phase 3 dose of venetoclax in combination with azacitidine will be determined and ...

The purpose of this study is to measure the effect of Hematopoietic Stem Cell Transplantation (HSCT) on symptoms of CSF1R-related Leukoencephalopathy.

The primary purpose of this study is to assess and analyze the skin microbiota composition (abundance, diversity, specific organisms) in patients in the pre-and post-alloHSCT setting.

The primary purpose of this study is to estimate and compare overall survival between the two arms:  patients who are Very Likely to find a Matched Unrelated Donor (MUD) versus those who are Very Unlikely to find a MUD.

The aim of this study is to measure the differences in quality of life and mood of hematopoietic stem cell transplant (HCT) patients and their caregivers staying at a hospital hospitality house (HHH), such as the Gift of Life Transplant House, the Help in Healing Home, and the Gabriel House of Care versus staying at a hotel/rental apartment or house. The goal is to investigate if staying in a HHH, with its different environment and support systems and programs, has a positive impact on the quality of life (QOL) and mood of patients undergoing a HCT and their caregivers.

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.

The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability of pegcetacoplan in patients with TA-TMA.

The primary objective of this study is to demonstrate the efficacy of Iomab-B, in conjunction with a Reduced Intensity Conditioning (RIC) regimen and protocol-specified allogeneic hematopoietic stem cell transplant (HCT), versus Conventional Care.

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 evaluate the clinical performance of the Aptima CMV Quant assay on the Panther system in ethylenediaminetetraacetic acid (EDTA) plasma samples from solid organ transplantation recipients (SOTR) and hematopoietic stem cell transplant recipients (HSCTR).

The purpose of this study is to determine the set of assessments and biomarkers that could together constitute a robust and valid composite health risk model for accurate personalized estimation of one year NRM.

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.

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 validate the effectiveness of the ZephyrLife Home monitoring device compared with standard ICU or stepdown vital signs monitoring,  especially for heart rate, respiratory rate and temperature as systemic (whole body) inflammatory response syndrome or sepsis ( whole body infection) markers in stem cell transplant patients.

The purpose of this study is to determine the impact of yoga on quality of life, flexibility and strength in patients following allogeneic stem cell transplant.

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 collect both survey and qualitative data from patients and caregivers in order to obtain descriptive data necessary to formulate and develop future empirical studies and intervention efforts that address bone marrow transplant (BMT) patient/caregiver well-being.

The purpose of this study is to correlate gut microbiome with specific cancer diagnoses and the clinical response (effectiveness), and adverse effects of cancer therapy (single or multiple) and stem cell transplant.

The purpose of this study is to develop tools to better predict which patients will be at highest risk of lung complications following bone marrow transplantation.

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

The purpose of this study is to test whether adding certain genetic factors to the process of picking a stem cell donor can decrease the chances that the patient's leukemia will come back after bone marrow transplantation. Stem cell donors are "matched" based on genes called human leukocyte antigens (HLA). Currently, donors are selected largely on the basis of HLA gene typing alone. There is published data to show that donors with specific other genes called killer immunoglobulin-like receptors (KIR) may protect AML patients from having their leukemia return after a transplant. In this study, the best HLA matched donors will ...

The purpose of this study is to compare the 1-year cumulative incidence of severe GVHD (from day of HCT) defined as Grade III-IV acute GVHD (aGVHD) and/or chronic GVHD (cGVHD) that requires systemic immunosuppression and to compare the disease free survival (DFS) (from time of randomization) in children and young adults (AYA) with acute myeloid leukemia (AML), acute lymphoid leukemia (ALL), and Myelodysplastic Syndrome (MDS) who are randomly assigned to haploHCT or to an 8/8 adult MUD HCT.

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 goal of this project is to improve outcomes for patients receiving bone marrow transplant (BMT) and their caregivers by providing a caregiving educational intervention. 

The purpose of this study is to develop digital, personal narrative stories about hematopoietic stem cell transplantation (HCT) with a sample of HCT caregivers. 

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 purpose of this study is to confirm a safe dose and schedule as well as the preliminary effectiveness of siremadlin alone, and in combination with donor lymphocyte infusion (DLI), in adult participants with acute myeloid leukemia (AML) who are in remission following allogeneic stem cell transplantation (allo-SCT) but are at high risk for relapse based on the presence of pre-transplant risk factors.

This is a double-blind, sham-controlled clinical study to evaluate the safety and feasibility of AMI MultiStem therapy in subjects who have had a heart attack (Non-ST elevation MI).

The purpose of this study is to better understand the distress experience of hospitalized patients undergoing hematopoietic stem cell transplant (HSCT), and to examine the relationship between cancer distress, psychological trauma, and resiliency over time.

The purpose of this study is to evaluate quality of life over time in patients treated with CAR-T therapy compared with autologous and allogeneic stem cell transplant.

This randomized phase III trial studies ibrutinib to see how well it works compared to placebo when given before and after stem cell transplant in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Before transplant, stem cells are taken from patients and stored. Patients then receive high doses of chemotherapy to kill cancer cells and make room for healthy cells. After treatment, the stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Ibrutinib is a ...

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 primary objective of the United States Food and Drug Administration (FDA) for this study is to demonstrate non-inferiority in subjects who received an allogeneic BMT for subjects randomized to Rezafungin for Injection compared to subjects randomized to the standard antimicrobial regimen (SAR) for fungal-free survival at Day 90 (±7 days).

The primary objective of the European Medicines Agency (EMA) for this study is to demonstrate superiority in subjects who received an allogeneic BMT randomized to Rezafungin for Injection compared to subjects randomized to the SAR for fungal-free survival at Day 90 (±7 days).