UC Davis Health Clinical Studies

Experimental Vedolizumab for Acute Graft Versus Host Disease (aGVHD) in Stem Cell Transplants

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Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a vital therapy. It is used in patients that have various forms of blood cancer. In these patients, the risk of disease recurrence or progression is significant. In this treatment, the patient first receives chemotherapy and/or radiation therapy. This kills blood–forming cells (cells from which all blood cells develop). Then, they receive blood-forming stem cells. These are taken from a genetically similar donor. There can be a complication of graft versus-host disease (GvHD) after this procedure. GvHD occurs when some types of white blood cell (T cells) in the donated cells (the graft) attack your own body cells. This happens because the graft see your body cells (the host) as foreign and attacks them. GvHD can vary in severity depending upon how soon it occurs after transplant. Acute GvHD occurs under 100 days after an allo-HSCT, but can also occur beyond 100 days. Acute graft versus-host disease (aGvHD) most commonly involves the skin, liver or intestines. This study will follow patients for the development of intestinal aGvHD during the first 180 days after allo-HSCT. This research study will test the safety and effectiveness of experimental Vedolizumab. It will be compared to placebo (dummy drug). It is being tested for the prevention of intestinal aGvHD. It will be given to patients undergoing allo-HSCT from an unrelated donor for a hematologic malignancy. These are cancers that affect the blood and/or lymphatic system. This clinical research study will test the anti-inflammatory properties of Vedolizumab. It is given intravenously (IV) directly into your vein using a needle.

Drug study, Phase 3
Any, age 12 years or older

Effectiveness and Safety of Experimental BIIB093 (Glibenclamide) for Severe Cerebral Edema (fluid around brain) After Stroke

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This is a Phase 3 study. This means that experimental BIIB093 (the study drug) has already been tested in previous research studies. It has been tested in a small number of people with large hemispheric infarction (LHI). LHI is a type of stroke. An ischemic stroke occurs when blood flow to parts of the brain is blocked, such as by a blood clot. This can cause damage to the brain. In LHI a large portion of the brain is damaged. People who have LHI can develop swelling of the brain called cerebral edema, which can worsen the symptoms and outcomes of LHI. Previous studies suggested that the study drug was safe, did not cause serious side effects or discomfort, and may reduce brain swelling, disability, and death in subjects with LHI. In this study, we want to investigate the study drug in a larger number of subjects (hundreds) to know more about it. Currently, there are no medications available to specifically reduce brain swelling caused by LHI. In this study, we want to test how well the study drug works to improve functional outcomes (the ability to do normal daily activities, such as walking and getting dressed) in subjects with LHI. This study will also look at the long-term effects of the study drug over time and see how safe the study drug is. What medication is being investigated? The study drug is an experimental drug. “Experimental” means that the study drug is currently being tested and is not approved for sale by the FDA. The study drug is already used in the form of tablets to treat subjects with type 2 diabetes. It is now being investigated as an intravenous infusion (given through a needle into the vein) in subjects with LHI. The study drug is designed to specifically stick to a protein called sulfonylurea receptor 1 (SUR1) and block its activity. SUR1 is found on brain cells and studies have shown that it is involved in the development of cerebral edema after a stroke. By blocking the activity of SUR1, it is hoped that the study drug may reduce brain swelling following LHI. Therefore, it could reduce the damage to the brain. In this study, subjects will receive either the study drug or a placebo. A placebo looks like the study drug but contains no actual medication. You have an equal chance of receiving the study drug or placebo. The study is double-blinded. This means that you and your study doctor will not know which study medication (study drug or placebo) you are receiving. In an emergency, we can find out what study medication you are receiving.

Drug study, Phase 3
Any, age 18 to 85 years old

Study of Experimental ASTX660 For Advanced Solid Tumors and Lymphomas

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The purpose of the study is to test the safety of ASTX660 and to see if this drug has an effect on treating your cancer. The drug (ASTX660) that will be given to you in this study is investigational. This means it has not yet been approved for treatment of any disease, including cancer. There are 2 phases in this study, Phase 1 (early stage) and Phase 2 (later stage). Phase 1 has now been completed. In Phase 1, successive small groups of subjects (people who take part in research studies are referred to as "subjects") received increasing doses of the study drug (ASTX660), to find the highest dose that could be safely given to most subjects and also produce the expected effects on tumor cells. The results of the Phase 1 part of the study have led to the identification of a recommended dose to use in Phase 2, as described later in this document. The Phase 2 part of the study will evaluate the effect of the study drug in subjects with specific tumor types. This ICF applies to Phase 2.

Drug study, Phase [/1/,/ /2/]
Any, age 18 years or older

Serologic (blood-based) Response of COVID-19 (Coronavirus) Patients

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The novel coronavirus (COVID19) has caused a global pendemic. Some patients have had symptoms and were tested for the infection. Many others developed immunity from the virus, but never had symptoms. These patients can be identified by an antibody test (blood test). These are new tests and the accuracy of them has not been determined. We are asking for blood from patients who have been tested for COVID-19 to determine how well these new antibody blood tests work. We also would like to see how your immune system responded to the infection and arealso asking for saliva samples for testing of antibodies. Blood cells will be taken and in the lab exposed to the virus to see how they kill this new virus. We will also look at your blood cells under a microscope to see if there are any abnormalities.

Other Study
Any, age 18 years and older

Safety, Tolerability, and Effect of Experimental ARO-AAT on the Liver and Blood For Alpha-1 Antitrypsin (AAT) Deficiency

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Alpha-1 Antitrypsin (AAT) is a naturally occurring protein. It helps to protect lungs from inflammation. Normal AAT, also known as M-AAT, works by turning off an enzyme called neutrophil elastase. Neutrophil elastase can become activated when the lungs are irritated or inflamed. A mutation in the AAT gene (a change in the body’s genetic instructions on how to make AAT) causes it to be made incorrectly. This means that very little of it gets into the bloodstream. Even if it makes it into the bloodstream, the poorly made AAT does not turn off neutrophil elastase very well. This causes breakdown of normal lung tissue, causing lung damage known as emphysema. Also, as AAT is mainly manufactured in the liver, incorrectly made AAT can accumulate and clog up liver cells, causing liver damage. These most abnormal AAT proteins are called Z-AAT. Subjects with genetic instructions for Z-AAT are at the greatest risk for AATD related lung and liver disease. ARO-AAT is a drug being developed by a company called Arrowhead Pharmaceuticals, Inc. ARO-AAT is investigational (experimental), which means that it is not approved by the FDA. In a patient with AATD, ARO-AAT may stop the mutated protein from being made. In animal studies, ARO-AAT has been shown to reduce the levels of abnormal AAT protein in the blood and in the liver. ARO-AAT given to human volunteers has been shown to decrease levels of AAT in the blood. This is thought to show that there is reduced production of AAT by the liver. This study is being carried out to see how safe and well tolerated ARO-AAT is. The study team hopes to see if low, medium and high doses of the study treatment will decrease Alpha-1 Antitrypsin in the blood and in the liver. Study treatment will be compared to a placebo, or dummy injection. A dummy treatment looks like a genuine medicine but contains no active ingredient.

Drug study, Phase [/2/,/ /3/]
Any, age 18 to 75 years old

Experimental Immunotherapy (Nivolumab or Brentuximab Vedotin) With Chemotherapy for Advanced Stage Classical Hodgkin Lymphoma

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This study is being done to answer the following question: Which treatment will extend your time without disease more? - Adding the study drug nivolumab to standard chemotherapy OR - Adding the study drug brentuximab vedotin to standard chemotherapy We will also compare any side effects you may have and your well-being when you take the study drugs and for up to ten years after you stop taking these drugs to treat the cancer. The usual approach for adults who are not in a study is treatment with standard chemotherapy. These treatments have been approved by the FDA. The usual approach for children and adolescents who are not in a study is treatment with standard chemotherapy, which may be followed by radiation therapy. Chemotherapy is a name for drugs that fight cancer cells. Radiation therapy is the use of high energy x-rays to kill cancer cells. There are several chemotherapy drugs approved by the FDA that are commonly used with the radiation therapy.

Drug study, Phase 3
Any, age 12 years or older

A Study of Two Different Ablation Methods (Transseptal vs Retrograde) to Reduce Systemic Emboli (blood clots)

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The purpose of this study is to compare two different methods of performing an ablation. An ablation is a procedure to treat your abnormal heart rhythm by making small scars in your heart tissue. This prevents abnormal electric signals from moving through your heart. In the United States, both methods in this study are used regularly. No one has studied whether one method is better than the other at preventing blood clots or other particles that can travel to the brain and cause blockages leading to possible loss of mental ability. The difference between the two methods is the way that the doctor will approach your heart to treat your abnormal hearth rhythm. Your doctor has experience with both methods and uses both in the course of normal medical care. To perform your ablation procedure, the doctor needs to use a catheter (a long flexible thin tube). It will be used to enter the left ventricle, an area of your heart that will be treated.

Procedure study
Any, age 18 years or older

The Walnut Study: Measuring the Changes in Gut Microbiota (bacteria) and Cardiometabolic Biomarkers (cholesterol)

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This study will test if eating walnuts will cause any changes in your gut microbiota (bacteria) or blood lipid profiles (cholesterol). We believe that eating walnuts will cause changes in the composition and metabolic activity of the gut microbiota. This can be measured in fecal (stool) samples. We believe that eating walnuts will improve blood lipid profiles and other markers of cardiometabolic health. This is measured in blood and urine samples, and compared to control diet without nuts.

Other study
Any, age 20 to 65 years old

Experimental Inotuzumab Ozogamicin and Chemotherapy for Types of Leukemia

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The goals of this study are to study: · For High-Risk B-ALL (HR B-ALL): Whether adding experimental inotuzumab ozogamicin (InO) to standard chemotherapy maintains or improves outcomes. · For High-Risk B-ALL (HR B-ALL): Whether treating both males and females for 2 years from the start of Interim Maintenance maintains outcomes for males who have previously been treated for 3 years from the start of Interim Maintenance. · For High-Risk Favorable (HR-Fav) : To describe outcomes for patients when treated with one phase of Interim Maintenance instead of two. Also, when treating both males and females with the same duration of chemotherapy (2 years from the start of Interim Maintenance)

Drug study, Phase 3
Any, age 1 to 24 years old

Experimental Erdafitinib for Relapsed/Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorder

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This is a Phase 2 study of an experimental drug called JNJ-42756493 (erdafitinib). In a Phase 2 study, the goal is to find out what effects, good and/or bad, a drug has on your tumor or type of cancer. We are using JNJ-42756493 (erdafitinib) in this study because it has been shown to block the growth of cancer cells with changes (mutations) in the FGFR1/2/3/4 genes. These mutations help cancer cells grow in test tubes and in animals. You are eligible for this study because your tumor was found to have a mutation in one of these genes. JNJ-42756493 (erdafitinib) is considered a study drug in the treatment of your tumor or type of cancer, we do not know if it will work against the type of tumor you have. A Phase 1 study of JNJ-42756493 (erdafitinib) has been completed in adults with cancer. In the Phase 1 study, researchers determined the dose of JNJ-42756493 (erdafitinib) can be given without too many side effects. This study will be the first time that JNJ-42756494 (erdafitinib) is given to children. The dose used in this study will be based on the dose used in adults. If you have bad side effects, your dose may be decreased. The goals of this study are: The main goal is to test any good and bad effects of the study drug JNJ-42756493 (erdafitinib) on your tumor. A second goal of the study is to evaluate side effects that might be caused by JNJ-42756493 (erdafitinib). Another goal is to learn more about the pharmacology (how your body handles the drug) of JNJ-42756493 (erdafitinib)

Drug study, Phase 2
Any, age 1 to 21 years old
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