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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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Quality Of Life And Symptomatic Response In Myelofibrosis Patients Receiving An Allogeneic Stem Cell Transplant
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the effect your disease and the treatment of allogeneic stem cell transplant has upon you before and after your treatment process through questionnaires at certain time points.
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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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A Study to Assess Physical Activity Among Hematopoietic Cell Transplant Recipients and Their Caregivers
Scottsdale/Phoenix, AZ
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.
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A Study to Assess CSF1R-related Leukoencephalopathy After Stem Cell Transplantation
Jacksonville, FL
The purpose of this study is to measure the effect of Hematopoietic Stem Cell Transplantation (HSCT) on symptoms of CSF1R-related Leukoencephalopathy.
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A Study to Evaluate the Skin Microbiome in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Jacksonville, FL
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.
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A Study Evaluating Safety And Efficacy Of Venetoclax In Combination With Azacitidine Versus Standard Of Care After Allogeneic Stem Cell Transplantation (SCT) In Participants With Acute Myeloid Leukemia (AML)
Jacksonville, FL; Rochester, MN
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 ...
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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 Evaluate The Pharmacokinetics (PK), Safety And Tolerability Of Pegcetacoplan In Patients With TA-TMA After Hematopoietic Stem Cell Transplantation (HSCT)
Rochester, MN
The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability of pegcetacoplan in patients with TA-TMA.
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A Study of a Wearable Vital Signs Monitoring Device for the Detection of Systemic Inflammatory Response Syndrome and Sepsis in Stem Cell Transplant Patients
Scottsdale/Phoenix, AZ
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.
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Patient And Caregiver Experience Of Bone Marrow Transplant
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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.
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A Study To Evaluate The Role Of Gut Microbiome In Cancer Therapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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.
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Coping With Hematopoietic Stem Cell Transplantation And Psychosocial
Scottsdale/Phoenix, AZ
The purpose of this study is to develop digital, personal narrative stories about hematopoietic stem cell transplantation (HCT) with a sample of HCT caregivers.
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Selection Of Allogeneic Hematopoietic Cell Donors Based On KIR And HLA Genotypes
Rochester, MN
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 ...
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A Study of Outcomes for Patients and Caregivers Receiving Bone Marrow Transplant (BMT) by Providing a Caregiving Educational Intervention
Rochester, MN
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.
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A Phase 2 Trial Of AMI MultiStem® Therapy In Subjects With Non-ST Elevation Acute Myocardial Infarction
Scottsdale/Phoenix, AZ
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).
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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.
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Study Of Rezafungin Compared To Standard Antimicrobial Regimen For Prevention Of Invasive Fungal Diseases In Adults Undergoing Allogeneic Blood And Marrow Transplantation (ReSPECT)
Rochester, MN
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).