NEWS HIGHLIGHTS
Clinical Trials Related to Uvadex (Methoxsalen)
A Safety and Efficacy Study of Uvadex and Extracorporeal Photopheresis (ECP) in Chronic Graft Versus Host Disease [Recruiting]
The purpose of this study is to evaluate the safety and effectiveness of extracorporeal
photopheresis therapy when added to standard drug therapies administered to patients with
moderate to severe chronic graft-versus-host disease.
RHIV A Pilot Study Refractory or Intolerant to Highly Active Antiretroviral Therapy (HAART) [Recruiting]
The objectives of this clinical trial are to:
- Assess the safety of using extracorporeal photoimmune therapy with the photosensitizing
agent Uvadex in the treatment of HIV-1 infection;
- Evaluate the effects of this therapy on HIV-1 viral load by polymerase chain reaction
(PCR) analysis;
- Evaluate the effects of this therapy on CD4+, CD8+ cells and CD4/CD8 ratio;
- Evaluate the effects of this therapy on the patient's immune system, by skin reactivity
to a standard anergy panel.
PUVA Maintenance Therapy in Mycosis Fungoides [Not yet recruiting]
The purpose of the study is to determine whether psoralen plus UVA (PUVA) photochemotherapy
maintenance treatment prolongs disease-free survival of cutaneous T cell lymphoma (mycosis
fungoides) patients.
Extracorporeal Photopheresis Pilot Study [Recruiting]
ECP will be given to the patients [UVAR®XTS TM Therakos system, Johnson & Johnson] according
to the following schedule:
Starting at day 21 after transplant, if hematologic recovery allowed it: 2 ECP per week the
first 2 weeks, and 1 ECP per week during 1 month.
Total = 8 ECP after transplantation.
Addition of Etanercept and Extracorporeal Photopheresis (ECP) to Standard Graft-Versus-Host Disease (GVHD) Prophylaxis in Stem Cell Transplant [Recruiting]
This research study investigates the benefits and possible risks of adding both etanercept
(Enbrel) and ECP (extracorporeal photopheresis) to the conventional preventative (or
prophylactic) treatments for graft-versus-host disease (GVHD). GVHD is a common, serious,
and too often fatal, complication after matched unrelated donor stem cell transplantation,
regardless of the pre-transplant conditioning regimen used (full or reduced intensity).
Reduced intensity transplants which employ lower doses of chemotherapy during the
conditioning phase of the transplant, are less toxic than full intensity transplants.
Reduced intensity transplants may extend the unrelated donor transplant option to older
patients or to patients with existing medical conditions or illness, where a full intensity
transplant is not possible. To be successful, reduced intensity transplants need to offset
any lower effectiveness in killing cancer cells during the conditioning phase, with the
establishment of a donor cell, graft-versus-leukemia effect (GVL). The GVL effect and GVHD
are associated with each other and therefore, the goal of GVHD prophylaxis for this study is
not so much to prevent all GVHD, but rather to prevent serious and fatal acute GVHD.
Most GVHD-related deaths are either the direct consequence of severe GVHD or from infections
associated with intense immunosuppression, a consequence of the standard treatments for
acute GVHD, which almost always include high-dose steroids. A more effective prophylaxis
therapy that allows for the GVL effect to develop, while limiting the exposure to high-dose
steroids may reduce transplant mortality and morbidity. We also will study how key chemical
and cellular factors relate to clinical outcome.
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