UC Davis Health Clinical Studies

A Study of Experimetnal Tabelecleucel After Failed Standard Treatment for Solid Organ Transplants With Epstein-Barr Virus

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This is a research study for patients with EBV-associated Post-Transplant Lymphoproliferative Disorder (EBV-PTLD). The study is for patients after a solid organ transplant (SOT) that didn’t respond to rituximab therapy with or without chemotherapy. This study will use a new treatment called tabelecleucel (also known as ATA129). Epstein-Barr Virus (EBV) is the virus that causes mononucleosis, also known as “mono”. Almost all adults have had EBV. For most people, EBV never causes a health problem. For people whose immune system is not working properly EBV can cause certain diseases where cells grow abnormally. This may happen in people who have had a transplant and those who have immune disorders. EBV-associated Post-Transplant Lymphoproliferative Disease (EBV-PTLD) can occur after a solid organ transplant (SOT). EBV infects immune cells in your blood, called B cells. In patients who have had an SOT, their immune system is suppressed because of the transplant. These infected immune cells can become cancerous. This research study is for patients who have EBV-PTLD following an SOT. It has not responded well to treatment with rituximab or rituximab and chemotherapy. Participants will receive experimetnal tabelecleucel. This is a product containing special immune allogeneic cells. The cells are called EBV-Cytotoxic T Lymphocytes (EBV-CTLs). They are made in the laboratory starting with cells from a healthy person who is immune to EBV. Your treatment will be selected specifically for you from a library of frozen tabelecleucel. It will be matched using certain human leukocyte antigens (HLAs). Treatment with tabelecleucel is experimental and is not approved by the FDA for use in the general public. It has been approved for testing in clinical trials. Tabelecleucel is made by taking donor cells from a healthy person. The cells that fight EBV (EBVCTLs) are grown in a laboratory for several weeks. They are then stored in a freezer until they are matched to a patient needing treatment. The cells are not genetically modified. This process is repeated using multiple donors in order to create a library of tabelecleucel products.

Biological study, Phase 3
Any, age -1 years or older

Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute...

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The standard treatment for Ph+ ALL is based on therapy used by the European “EsPhALL” group. It consists of a chemotherapy backbone combined with a TKI, and has many side effects. This study looks at how well a different chemotherapy given together with a TKI drug called imatinib works. It will be given to children and young adults with Ph+ ALL. This combination is experimental. The overall goal of this study is to compare the effects of a less intensive chemotherapy backbone combined with imatinib on children and young adults with Ph+ ALL. In this study you will get either the standard chemotherapy backbone together with imatinib, or the less intensive chemotherapy backbone with imatinib. You will not get both.

Procedure study, Phase 3
Any, age 2 to 21 years old

Web-Based Physical Activity Intervention to Improve Long Term Health in Children and Adolescents With Acute Lymphoblastic Leukemia

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Regular physical activity helps maintain a healthy weight, improves energy levels and overall health. Children and teenagers who have received treatment for cancer are often less active. They may gain weight and have more health problems, compared to children and teenagers who have not received treatment for cancer. This study looks at physical activity and its effect on your health. This study will use a variety of interventions to see if they affect how active you are over time. The overall goal of this study is to • Study the effect of a reward-based website on fitness, quality of life and lab tests associated with physical health. The study is for children and teenagers who have completed therapy for Acute Lymphoblastic Leukemia (ALL).

Other study
Any, age 8 to 15 years old

A Study of Mammographic Breast Density For Hormone Receptor-Negative Breast Cancer Enrolled on Study A011502

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This study is being done as a companion study to the Alliance A011502 clinical trial. The purpose of this study is to see if the use of aspirin causes a decrease in mammographic breast density. The breast is composed of fat, milk glands and various other tissues. These determine how dense the breasts are. High breast density has been shown to be a strong risk factor for developing breast cancer. It is thought that decreasing breast density may decrease the risk for breast cancer. The main goal of this study is to see whether women treated with aspirin will have reduced breast density as seen on a mammogram. Breast density is determined by a mammogram, and cannot be determined by a physical exam.

Procedure study
Female, age -1 years or older

A Study of the Experimental Combination of Cediranib and Olaparib in Advanced Solid Tumors

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You are being asked to take part in this study because you have an advanced solid cancer. You have already been treated with chemotherapy and your disease is now growing. People who are not in a study are usually treated with more chemotherapy, radiation or surgery. Sometimes, combinations of these are used. These treatments can reduce symptoms and may stop the tumor from growing for several months or more. The purpose of this study is to test any good and bad effects of this combination of drugs - cediranib and olaparib. This combination could shrink your cancer but it could also cause side effects. Researchers hope to learn if this combination of the drugs will shrink the cancer by at least one-quarter compared to its present size. Cediranib is an experimental drug. Olaparib has already been FDA-approved to treat patients with advanced ovarian cancer. The use of the combination of cediranib and olaparib in treatment of patients with your cancer is experimental.

Other study, Phase 2
Any, age 18 years or older
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