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UC Davis Health Clinical Studies

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

Testing an Experimental Anti-Cancer Drug M3814 for Relapsed or Refractory Acute Myeloid Leukemia

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This study is being done to answer the following question: Can we lower the chance of your acute myeloid leukemia growing or spreading by adding an experimental new drug to the usual combination of drugs? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your acute myeloid leukemia. The usual approach is defined as care most people get for acute myeloid leukemia.

Drug study, Phase 1
Any, age 18 years or older

An Experimental Combination Study of S1803, Daratumumab/rHuPh20 +/- Lenalidomide for Multiple Myeloma (MM)

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This study is being done to answer the following questions: 1. Will adding the experimetnal drug daratumumab/rHuPH20 to the usual maintenance treatment help multiple myeloma patients survive longer? 2. For patients who have no evidence of multiple myeloma in their bone marrow, should maintenance therapy be stopped after 2 years? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your multiple myeloma. The usual approach is defined as care most people get for multiple myeloma. The usual approach for patients who are not in a study is treatment with an FDA approved multiple myeloma drug (such as lenalidomide) after stem cell transplant.

Drug study, Phase 3
Any, age 18 to 75 years old

A Study of Experimental Blinatumomab for Localized B Cell Lymphoblastic Lymphoma (B-LLy)

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You are being asked to take part in this research study because you have been diagnosed with Standard Risk-High B-cell Lymphoblastic Leukemia (SR-High B-ALL). Taking part in this study is voluntary. You may choose not to be in this study. If you decide not to be in this study, you will not be penalized and you will not lose any benefits to which you are entitled. You will still receive medical care. The overall goal of this study is to: • Compare the effects, good and/or bad, of adding blinatumomab to standard chemotherapy in subjects with SR-High B-ALL to find out which is better. The treatment involves cancer fighting medicine called chemotherapy. You have already been receiving chemotherapy for the past month. The treatment may also include the investigational medicine blinatumomab. The treatment on this study takes about 2-2 ¼ years. It is divided into 5-7 phases, depending on the treatment plan you receive. All people who receive cancer treatment are at risk of having side effects. In addition to killing tumor cells, cancer chemotherapy can damage normal tissue and produce side effects. In this study you will get 1 of 2 treatment plans. The 2 treatment plans are called Arms C and D. The 2 treatment plans are the same except for whether or not you will get the investigational medicine blinatumomab. The rest of the treatment that is given is standard therapy for people with SR-High B-ALL. On this study, Arm C is standard therapy and Arm D uses the investigational medicine blinatumomab in addition to standard therapy.

Drug study, Phase 3
Any, age -1 to 31 years old

Experimental Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)

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RELIANCE is a study comparing two drugs. We are trying to learn which one works better, and is better tolerated in people with Chronic Obstructive Pulmonary Disease (COPD). COPD is a lung disease. We want to compare these drugs in a real world setting. Today, doctors use both Roflumilast and Azithromycin to treat COPD. Research shows that people who take Roflumilast or Azithromycin go to the hospital less often for COPD attacks. The Food and Drug Administration (FDA) has approved Roflumilast for treating COPD with chronic bronchitis. The FDA has not approved Azithromycin for treating COPD. However, the FDA has approved Azithromycin for treating infections. Doctors are allowed to use Azithromycin to treat other conditions when they think it will help their patients. No studies have compared the two medicines to each other. We want to see if Azithromycin is as good as Roflumilast for preventing COPD attacks and thereby decrease hospital visits. Doctors don’t know which drug works best for whom. There are different types of COPD patients, such as current smokers and past smokers. We want to know if one of these medicines is better for patients who smoke.

Drug study, Phase 3
Any, age 40 years or older

Study to Evaluate the Effectiveness and Safety of Experimental PANZYGA in Children With Chronic Immune Thrombocytopenia (ITP)

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PANZYGA is a solution for intravenous (IV) dosing (injection of the drug with a needle into a vein). It contains human antibodies also called immunoglobulin (Ig), which are protective blood proteins. PANZYGA is licensed in the US for use in adult and pediatric patients with Primary Immune Deficiency. It is also approved for adults with Immune Thrombocytopenia (ITP). For children, the study drug is an experimental drug. An experimental drug is one that has not been approved for use in this population but has been approved for this study. ITP is a blood disorder in which the immune system produces antibodies that attack and destroy the body's own blood platelets. These platelets play a major part in the blood clotting process. In a healthy person 150,000 to 400,000 platelets per microliter blood is normal. In an ITP patient this may fall below 5,000. The mechanism of action of immunoglobulins in ITP is not fully understood. However, intravenously administered immunoglobulins (IVIg) have become a first-line treatment option for selected patients with ITP. The dose to be given is also generally accepted. The purpose of this study is to investigate the effectiveness and safety of PANZYGA. It will be tested in pediatric patients with chronic ITP. We hope to obtain marketing authorization for the treatment of ITP in children.

Biological study, Phase 4
Any, age 1 to 18 years old

A Study of Experimetnal VarIthena on Wound Healing in Venous Leg Ulcers (VLU)

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The purpose of this registry is to look at how experimental Varithena® injectable foam works. It will be given to patients who have chronic venous insufficiency (commonly known as “varicose veins”) with leg wounds. The decision to provide you with such medication has been left up to your treating physician and is not being driven by or impacted by this study. The purpose of this project is to collect data about your leg wounds. We hope to learn the impact of treatment on the rate of healing, the rate of repeated wounds, as well as the impacts to your level of pain and quality of life.

Drug study
Any, age 18 years or older
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