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A Prospective, Observational Cohort Study Of Participants At Risk For Chronic Graft-Versus-Host Disease In The United States (THRIVE)
Scottsdale/Phoenix, AZ
Jacksonville, FL
Rochester, MN
The purpose of this study is to collect data from participants who have recently had an allogenic Stem Cell Transplant(alloSCT) and are at risk of Chronic Graft Versus Host Disease(cGVHD).
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A Randomized Phase III Study To Evaluate Benefits Of Autologous Stem Cell Transplant In Patients With Peripheral T Cell Lymphoma That Achieved A First Complete Remission (CR1) Following Induction Therapy (PTCL-STAT)
Scottsdale/Phoenix, AZ
Jacksonville, FL
Rochester, MN
This phase III trial compares the effect of high dose chemotherapy and the patients' own (autologous) stem cells to observation only in patients with peripheral T-cell lymphoma who achieved a complete response after initial chemotherapy. Usual treatment after a complete response may include observation or high dose chemotherapy followed by an autologous stem cell transplant, however, it is not known if a transplant if beneficial. Giving chemotherapy before a stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Stem cells removed prior to treatment are then returned to the patient to replace the blood forming cells that were destroyed by the chemotherapy. Giving high dose chemotherapy followed by an autologous stem cell transplant may be more effective compared to observation only in treating patients with peripheral T-cell lymphoma who have achieved a complete response after initial chemotherapy.
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Evaluating For Clonal Hematopoiesis And Epigenetic Biomarkers Of Biological Aging In Patients With Autoimmune Diseases Undergoing Autologous Hematopoietic Cell Transplant (AHCT)
Jacksonville, FL
The purpose of this study is to quantify the burden of biological aging and CH in patients with autoimmune diseases undergoing AHCT. Assess the impact of AHCT on biological aging and CH in patients with autoimmune diseases.
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Expanded Access Study For The Treatment Of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel
Jacksonville, FL
Rochester, MN
The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with a disease approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.
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Multicenter, Randomized Phase II Study Of Epcoritamab For Patients With Aggressive B-Cell Lymphomas Achieving A Partial Response After CD19-Directed CAR-T Therapy
Jacksonville, FL
Rochester, MN
The purpose of this study is to compare epcoritamab to standard practice (observation) for the treatment of patients with B-cell lymphomas who are not in complete remission after treatment with CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy.
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Phase II Double-Blinded Placebo-Controlled Randomized Trial Of CSF-1R Inhibitor, Axatilimab For Prevention Of Acute And Chronic GVHD After HLA-Matched Related And Unrelated Donor Allogeneic Stem Cell Transplantation (ABRAXAS)
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, mucous membranes, and eyes, skin rash or blisters, dry mouth, or dry eyes. Typically, drugs such as cyclophosphamide, tacrolimus, and mycophenolate mofetil are given after the transplant to help stop GVHD from happening, but these current therapies may negatively affect patient quality of life and newer treatment strategies are needed. Axatilimab is a monoclonal antibody. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens), which may prevent GVHD from developing. Adding axatilimab to SOC therapy may be more effective in preventing GVHD following allogeneic HCT in patients with hematologic cancer.
Closed for Enrollment
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AGAVE-201, A Phase 2, Open-label, Randomized, Multicenter Study To Evaluate The Efficacy, Safety And Tolerability Of Axatilimab At 3 Different Doses In Patients With Recurrent Or Refractory Active Chronic Graft Versus Host Disease Who Have Received At Least 2 Lines Of Systemic Therapy
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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