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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR UVADEX

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Clinical Trials for Uvadex

Trial ID Title Status Sponsor Phase Summary
NCT00005092 Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer Completed National Cancer Institute (NCI) Phase 1 RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells are rejected by the body's normal tissues. Transplanting donated cells that have been treated with psoralen may prevent this from happening. PURPOSE: Phase I trial to study the effectiveness of chemotherapy, radiation therapy, and psoralen-treated donor cells in treating patients who are undergoing peripheral stem cell transplantation for hematologic cancer.
NCT00005092 Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer Completed M.D. Anderson Cancer Center Phase 1 RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells are rejected by the body's normal tissues. Transplanting donated cells that have been treated with psoralen may prevent this from happening. PURPOSE: Phase I trial to study the effectiveness of chemotherapy, radiation therapy, and psoralen-treated donor cells in treating patients who are undergoing peripheral stem cell transplantation for hematologic cancer.
NCT00054600 Safety and Efficacy Study of Photopheresis With UVADEX to Prevent Graft-versus-Host Disease Completed Mallinckrodt Phase 2 The purpose of this study is to determine whether Extracorporeal Photopheresis with UVADEX (ECP) prior to bone marrow or peripheral blood stem cell transplantation is effective in the prevention of Graft-versus-Host Disease (GvHD).
NCT00054613 Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease Completed Mallinckrodt Phase 2 The purpose of this study is to determine whether extracorporeal photoimmune therapy with UVADEX (ECP) added to standard therapy is effective in the treatment of chronic graft-versus-host disease (GvHD).
NCT00056355 Extracorporeal Photopheresis to Maintain Symptoms Remission During Steroid Withdrawal in Patients With Steroid-Dependent Crohn's Disease Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 This study will examine the safety and effectiveness of extracorporeal photopheresis (ECP) in controlling Crohn's disease symptoms as patients taper their corticosteroid dose. Crohn's disease is a chronic inflammatory bowel disease. Patients commonly have chronic diarrhea with abdominal pain, loss of appetite and weight loss. Acute disease flares are treated with large doses of corticosteroids, but long-term use of these drugs can have harmful side effects. ECP (described below), is approved to treat skin symptoms associated with a type of cancer called cutaneous T-cell lymphoma and has been used experimentally in conditions involving abnormal inflammation. Patients 18 years of age and older who have had Crohn's disease for at least 6 months, who are corticosteroid-dependent, and whose symptoms are controlled well enough so that their Crohn's Disease Activity Index (CDAI) is less than 220, may be eligible for this study. Candidates will be screened with a medical history and review of medical records, physical examination, electrocardiogram, blood tests, urine pregnancy test for women of childbearing potential, and a questionnaire about how Crohn's disease affects their life and activities. Patients with a CDAI score of less than 150 will begin ECP treatments as soon as possible. Those with scores from 150 to 219 will have their corticosteroid dose increased enough to bring their CDAI score to below 150 before beginning ECP. Patients who do not achieve a CDAI of less than 150 after 4 to 6 weeks of increased corticosteroids will be excluded from the study. Participants will have ECP treatments for 2 consecutive days every 2 weeks for 24 weeks, for a total of 26 treatments. For ECP, patients undergo leukapheresis, a method of collecting large numbers of white blood cells, or leukocytes-cells that may be responsible for many of the medical problems in Crohn's disease. Whole blood is collected through a needle in an arm vein, similar to donating a unit of blood. The blood flows through a machine that separates it into its components by spinning. The white cells are removed and collected in a plastic bag, and the red blood cells and plasma are returned to the patient's bloodstream through the same needle. The collected white cells are mixed with a drug called UVADEX® (Registered Trademark), exposed to ultraviolet (UVA) light, and then returned to the patients' bloodstream. (The UVADEX allows the blood cells to absorb more UVA.) The UVA changes the cells in a way that, once they are back in the body, they cause changes in other cells like them. Each ECP treatment takes 3 to 4 hours. On the first day of each 2-day treatment, patients will undergo a review of symptoms, check of vital signs, and blood draw. They will complete a CDAI diary for 7 days before the first of the two ECP treatments and a questionnaire about their life and activities at 4-week intervals. During the ECP treatment period, corticosteroids will be slowly reduced as long as disease symptoms do not worsen. Patients whose disease remains under control with cessation of all steroids may begin maintenance ECP, 2 days in a row every 4 weeks for an additional 20 weeks (another 10 treatments), with the same follow-up as described above, and a full physical examination 4 weeks after the final treatment. Patients who were able to reduce, but not stop, steroid treatment may be considered for maintenance therapy if it is thought that continuing treatment may enable further reduction of steroids. Patients whose disease symptoms worsen with ECP or who have not been able to decrease their steroid dose will not be eligible for maintenance therapy and their participation in the study will end.
NCT00221000 Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Rheumatoid Arthritis Completed Mallinckrodt Phase 2 Rheumatoid arthritis (RA) is a systemic autoimmune inflammatory disorder that can cause substantial pain and joint tenderness, significant joint damage, and serious disability. The treatment goals are minimization of the signs and symptoms of the disease, and the reduction of irreversible joint damage. As the understanding of the pathophysiological mechanisms underlying RA is elucidated, the opportunity to target specific inflammatory processes with new therapies has improved. Rheumatoid arthritis is a T cell-mediated autoimmune disease and there are various therapies, including newer experimental therapies, which target either the activation of T cells or the neutralization of their effector mechanisms. These newer therapies have shown benefit in human and animal models of RA. Extracorporeal photoimmune therapy (ECP) has been shown to be safe and effective in the palliative treatment of the skin manifestations of cutaneous T cell lymphoma. Experimental studies have also demonstrated activity of ECP treatment in several T cell mediated diseases including graft versus-host disease, rejection after organ transplantation, and selected autoimmune diseases. This study will evaluate a cell-based therapy (ECP) in patients who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs) and biological agents to determine if ECP treatment can reduce the signs and symptoms of RA in this refractory patient population.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Uvadex

Condition Name

Condition Name for Uvadex
Intervention Trials
Graft-versus-Host Disease 2
Graft Versus Host Disease 1
Mycosis Fungoides 1
Steroid Refractory Acute Graft Versus Host Disease 1
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Condition MeSH

Condition MeSH for Uvadex
Intervention Trials
Graft vs Host Disease 6
Lymphoma 2
Lymphoma, T-Cell, Cutaneous 2
Leukemia 2
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Clinical Trial Locations for Uvadex

Trials by Country

Trials by Country for Uvadex
Location Trials
United States 54
Germany 6
United Kingdom 6
France 5
Austria 5
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Trials by US State

Trials by US State for Uvadex
Location Trials
Texas 5
Florida 4
Illinois 4
New York 4
Michigan 4
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Clinical Trial Progress for Uvadex

Clinical Trial Phase

Clinical Trial Phase for Uvadex
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 2 5
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Clinical Trial Status

Clinical Trial Status for Uvadex
Clinical Trial Phase Trials
Completed 7
Terminated 1
Not yet recruiting 1
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Clinical Trial Sponsors for Uvadex

Sponsor Name

Sponsor Name for Uvadex
Sponsor Trials
Mallinckrodt 11
M.D. Anderson Cancer Center 2
Rush University Medical Center 1
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Sponsor Type

Sponsor Type for Uvadex
Sponsor Trials
Industry 14
Other 11
NIH 2
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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Fish and Richardson
McKinsey
Julphar
Daiichi Sankyo
Citi
Moodys
Johnson and Johnson
Fuji

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