NCT05718674 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Brosig A, Hahnel V, Orso E, Wolff D, Holler E, Ahrens N
Technical comparison of four different extracorporeal photopheresis systems. Transfusion. 2016 Oct;56(10):2510-2519. doi: 10.1111/trf.13728. Epub 2016 Jul 26.
Bueno JL, Alonso R, Gonzalez-Santillana C, Naya D, Romera I, Alarcon A, Aguilar M, Bautista G, Duarte R, Ussetti P, Cabrera JR
A paired trial comparing mononuclear cell collection in two machines for further inactivation through an inline or offline extr
Piccirillo N, Putzulu R, Massini G, Di Giovanni A, Chiusolo P, Sica S, Zini G
Inline extracorporeal photopheresis: evaluation of cell collection efficiency. Transfusion. 2019 Dec;59(12):3714-3720. doi: 10.1111/trf.15570. Epub 2019 Nov 4.
Piccirillo N, Putzulu R, Massini G, Fiore AG, Chiusolo P, Sica S, Zini G
Mononuclear cell collection for extracorporeal photopheresis: Concentrate characteristics for off-line UV-A irradiation procedure. J Clin Apher. 2018 Jun;33(3):217-221. doi: 10.1002
Worel N, Lehner E, Fuhrer H, Kalhs P, Rabitsch W, Mitterbauer M, Hopfinger G, Greinix HT
Extracorporeal photopheresis as second-line therapy for patients with acute graft-versus-host disease: does the number of cells treated matter? Transfusion. 2018 Apr

Photopheresis in GvHD After Hematopoietic Transplantation: Characteristics of the Procedure and of the Cell Product

Clinical trial NCT05718674 - References