Uvadex/Therakos Photopheresis (methoxsalen/ECP) / Mallinckrodt 
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  • ||||||||||  Uvadex/Therakos Photopheresis (methoxsalen/ECP) / Mallinckrodt
    Trial completion date, Trial primary completion date:  Photopheresis in Early-stage Mycosis Fungoides (clinicaltrials.gov) -  Apr 27, 2026   
    P2,  N=74, Recruiting, 
    Trial completion date: Jul 2027 --> Jul 2028 | Trial primary completion date: Mar 2026 --> Mar 2027
  • ||||||||||  Uvadex/Therakos Photopheresis (methoxsalen/ECP) / Mallinckrodt
    Enrollment change, Trial withdrawal, Checkpoint inhibition:  EPIC- Extracorporeal Photopheresis (ECP) for Immune-related Colitis (clinicaltrials.gov) -  Dec 27, 2025   
    P2,  N=0, Withdrawn, 
    Median age was 9 years in SR-aGvHD, (52 N=30 --> 0 | Suspended --> Withdrawn
  • ||||||||||  Uvadex/Therakos Photopheresis (methoxsalen/ECP) / Mallinckrodt
    Trial completion date:  Photopheresis in Early-stage Mycosis Fungoides (clinicaltrials.gov) -  Sep 23, 2025   
    P2,  N=74, Recruiting, 
    N=30 --> 0 | Suspended --> Withdrawn Trial completion date: Jul 2026 --> Jul 2027
  • ||||||||||  Uvadex/Therakos Photopheresis (methoxsalen/ECP) / Mallinckrodt
    Trial primary completion date:  Extracorporeal Photopheresis in Early Diffuse Cutaneous Systemic Sclerosis (clinicaltrials.gov) -  Mar 13, 2025   
    P2,  N=15, Not yet recruiting, 
    3. Trial primary completion date: Dec 2026 --> Jul 2026
  • ||||||||||  Uvadex/Therakos Photopheresis (methoxsalen/ECP) / Mallinckrodt
    Trial initiation date, Trial suspension, Checkpoint inhibition:  EPIC- Extracorporeal Photopheresis (ECP) for Immune-related Colitis (clinicaltrials.gov) -  Feb 28, 2025   
    P2,  N=30, Suspended, 
    Trial primary completion date: Dec 2026 --> Jul 2026 Initiation date: Jan 2025 --> Dec 2025 | Not yet recruiting --> Suspended
  • ||||||||||  Promacta (eltrombopag) / Novartis, Uvadex/Therakos Photopheresis (methoxsalen/ECP) / Mallinckrodt
    Cancelled: Minimal Effect of Eltrombopag Related Plasma Discoloration on Extracorporeal Photopheresis Efficiency () -  Oct 8, 2024 - Abstract #AABB2024AABB_393;    
    Our findings suggest that the serum chromogens associated with ELT and its metabolites should not interfere with substrate penetration by the high-energy UVA photons delivered during ECP nor the resultant immunomodulatory actions. Indeed, with no adjustments to the instrument calculated irradiation time our patient responded well, and no longer required oxygen supplementation well before his course of ECP was concluded.
  • ||||||||||  Uvadex/Therakos Photopheresis (methoxsalen/ECP) / Mallinckrodt
    Trial completion date, Trial primary completion date:  Extracorporeal Photopheresis in Early Diffuse Cutaneous Systemic Sclerosis (clinicaltrials.gov) -  Mar 2, 2024   
    P2,  N=15, Not yet recruiting, 
    Indeed, with no adjustments to the instrument calculated irradiation time our patient responded well, and no longer required oxygen supplementation well before his course of ECP was concluded. Trial completion date: Jun 2026 --> Jun 2027 | Trial primary completion date: Dec 2025 --> Dec 2026
  • ||||||||||  Uvadex/Therakos Photopheresis (methoxsalen/ECP) / Mallinckrodt
    Trial completion date, Trial primary completion date:  Extracorporeal Photopheresis in Early Diffuse Cutaneous Systemic Sclerosis (clinicaltrials.gov) -  Mar 8, 2023   
    P2,  N=15, Not yet recruiting, 
    When starting ECP, 33 (89%) had stage III/IV disease; 30 (77%) had erythroderma; 10.3%, 33.3% and 56.4% of pts had B0, B1 and B2 disease, respectively (Table 1). Trial completion date: Jun 2024 --> Jun 2026 | Trial primary completion date: Sep 2023 --> Dec 2025
  • ||||||||||  Uvadex/Therakos Photopheresis (methoxsalen/ECP) / Mallinckrodt
    New P2 trial:  Photopheresis in Early-stage Mycosis Fungoides (clinicaltrials.gov) -  Jan 11, 2023   
    P2,  N=80, Recruiting, 
  • ||||||||||  Uvadex/Therakos Photopheresis (methoxsalen/ECP) / Mallinckrodt
    Enrollment open:  Extracorporeal Photopheresis in Sezary Syndrome (clinicaltrials.gov) -  Jul 7, 2022   
    P2,  N=15, Recruiting, 
    Trial completion date: Jun 2024 --> Jun 2026 | Trial primary completion date: Sep 2023 --> Dec 2025 Not yet recruiting --> Recruiting
  • ||||||||||  Uvadex/Therakos Photopheresis (methoxsalen/ECP) / Mallinckrodt
    Trial initiation date:  Extracorporeal Photopheresis in Sezary Syndrome (clinicaltrials.gov) -  May 12, 2022   
    P2,  N=15, Not yet recruiting, 
    Use of the THERAKOS® CELLEX® Photopheresis System was effective in children with SR-aGvHD, with more than half experiencing improvement by day 28 and further responses observed over 12 weeks. Very few TEAEs were attributable to ECP, and no new safety signals were observed. Initiation date: Jan 2022 --> Jun 2022
  • ||||||||||  Uvadex/Therakos Photopheresis (methoxsalen/ECP) / Mallinckrodt
    Trial initiation date, Trial primary completion date:  Extracorporeal Photopheresis in Early Diffuse Cutaneous Systemic Sclerosis (clinicaltrials.gov) -  Apr 18, 2022   
    P2,  N=15, Not yet recruiting, 
    Initiation date: Jan 2022 --> Jun 2022 Initiation date: Mar 2022 --> Sep 2022 | Trial primary completion date: Mar 2023 --> Sep 2023
  • ||||||||||  Uvadex/Therakos Photopheresis (methoxsalen/ECP) / Mallinckrodt
    New P2 trial:  Extracorporeal Photopheresis in Sezary Syndrome (clinicaltrials.gov) -  Dec 14, 2021   
    P2,  N=15, Not yet recruiting, 
  • ||||||||||  Uvadex/Therakos Photopheresis (methoxsalen/ECP) / Mallinckrodt
    Trial completion date, Trial initiation date, Trial primary completion date:  Extracorporeal Photopheresis in Early Diffuse Cutaneous Systemic Sclerosis (clinicaltrials.gov) -  Nov 26, 2021   
    P2,  N=15, Not yet recruiting, 
    Initiation date: Mar 2022 --> Sep 2022 | Trial primary completion date: Mar 2023 --> Sep 2023 Trial completion date: Mar 2024 --> Jun 2024 | Initiation date: Sep 2021 --> Mar 2022 | Trial primary completion date: Sep 2023 --> Mar 2023
  • ||||||||||  Uvadex/Therakos Photopheresis (methoxsalen/ECP) / Mallinckrodt
    [VIRTUAL] EXTRACORPOREAL PHOTOPHERESIS - FIRST PROCEDURE PERFORMED IN THE APHERESIS SERVICE OF THE BLOOD BANK OF HOSPITAL SANTA MARCELINA - CASE REPORT () -  Oct 27, 2021 - Abstract #HEMO2021HEMO_783;    
    Introduction Extracorporeal Photopheresis (FEC) is based on the manipulation of T lymphocytes with photosensitizing substances that, when exposed to ultraviolet (UV) light, undergo apoptosis and, when returned to the patient, trigger a series of immunomodulatory effects. Few services have the equipment and we report the first experience of the Apheresis sector at Hospital Santa Marcelina in the use of FEC.Case report A 55-year-old male patient with Cutaneous T-Cell Lymphoma since 2017, previously treated with corticoids and CHOEP, no response ; from Dec/2017 to Jan/2018 he took methotrexate, partial response; changed to GVD from Feb/2018 to May/2018 and again partial response. New treatment with Cladribine in Jun/2018 with complete response. Oct/2018 again presents erythema and biopsy showed relapse. Interferon was prescribed and sent in Aug/2019 to our Bone Marrow Transplant Service (BMT), disease activity was found and FEC was indicated before BMT. Proposed the ASFA (American Society for Apheresis) protocol that recommends for Cutaneous T-Cell Lymphoma/Mycosis Fungoid/Sezary's Syndrome two photopheresis sessions on consecutive days (considered a cycle) and the cycle repeated after 2–4 weeks for 5–6 months. The photopheresis procedure is contraindicated when the leukometry is above 25,000/mm3, on 02/05/2020 the patient had total leukocytes of 26,540/mm3, being necessary to increase the dose of interferon and associate corticoids, a new blood count of 02/07/20 /2020 counting at 22,800/mm3, the first cycle was programmed and carried out on 10 and 11/02/2020. There was prior training for the nursing staff by the company of the THERAKOS CELLEX Photopheresis System and the first two procedures, from the first cycle, were followed-up in loco. The following cycles were performed with remote support, a total of 5 cycles (10 sessions of FEC) were performed, the patient always receiving guidance on care, in particular on the use of UVA protection: sunglasses, sunscreen, avoid direct sun exposure. Since the first procedure, he had fever hours after the procedure, the most common adverse reaction. However, the erythroderma worsened, in the second cycle it was more pronounced, and in the third cycle the symptoms were intensified with bullous lesions, and the patient was hospitalized on 03/25/2020. After dermatological evaluation, we suspected bullous pemphigoid or pharmacoderma secondary to medication or ultraviolet radiation. The FEC was suspended for a cycle and we resumed on 4/22/2020, we took a longer break, carrying out the 5th cycle on 5/26/2020. But the patient continued to present bullous lesions, and after the 5th cycle he remained hospitalized for treatment, and the sessions were suspended. The patient is discharged on 6/25/2020 with guidance for outpatient follow-up. Conclusion With the THERAKOS CELLEX Photopheresis System, the FEC procedure is easy to perform, and the person responsible for the procedure is responsible for specific actions, such as assembling the kit carefully for the set of lamps ultraviolet light and the placement of the photosensitizing solution (UVADEX Methoxsalen) on the collected product. It is fast, less than 60 minutes, and the patient must have adequate venous access to the peripheral flow or through a catheter. A good clinical history, verifying that the patient is not splenectomized (which contraindicates the procedure), and checking pre-procedural tests such as white blood cell count, coagulogram, lipid profile and bilirubin should be performed. The first experience in Extracorporeal Photopheresis of the Apheresis Service was fundamental for us to develop internal protocols with team training and interactions between all the sectors involved.
  • ||||||||||  Uvadex/Therakos Photopheresis (methoxsalen/ECP) / Mallinckrodt
    Enrollment change, Trial withdrawal:  PROMPT: Study of Photopheresis in the Treatment of Erythrodermic MF and SS (clinicaltrials.gov) -  Sep 8, 2021   
    P2,  N=0, Withdrawn, 
    Conclusion With the THERAKOS CELLEX Photopheresis System, the FEC procedure is easy to perform, and the person responsible for the procedure is responsible for specific actions, such as assembling the kit carefully for the set of lamps ultraviolet light and the placement of the photosensitizing solution (UVADEX Methoxsalen) on the collected product. It is fast, less than 60 minutes, and the patient must have adequate venous access to the peripheral flow or through a catheter. A good clinical history, verifying that the patient is not splenectomized (which contraindicates the procedure), and checking pre-procedural tests such as white blood cell count, coagulogram, lipid profile and bilirubin should be performed. The first experience in Extracorporeal Photopheresis of the Apheresis Service was fundamental for us to develop internal protocols with team training and interactions between all the sectors involved. N=46 --> 0 | Not yet recruiting --> Withdrawn
  • ||||||||||  Uvadex/Therakos Photopheresis (methoxsalen/ECP) / Mallinckrodt, J&J
    [VIRTUAL] Extracorporeal photopheresis for refractory scleroderma () -  Sep 9, 2020 - Abstract #BAD2020BAD_178;    
    Extracorporeal photopheresis (ECP), also known as extracorporeal photochemotherapy, is a leucapheresis‐based therapy whereby a patient's T cells are mixed with Uvadex® (methoxsalen) and exposed to ultraviolet A light, inactivating the T cells...Systemic treatment options include prednisolone, phototherapy, ciclosporin, methotrexate, mycophenolate and ECP...Unlike other immunosuppressive therapies, ECP has not been associated with an increased incidence of infections or second malignancies and improves functionality and QoL of patients. It is important to consider ECP as a therapeutic treatment option for refractory scleroderma.
  • ||||||||||  tacrolimus intravenous / Generic mfg., Uvadex/Therakos Photopheresis (methoxsalen/ECP) / Mallinckrodt, J&J
    Clinical, Journal:  Randomized controlled study of ECP with methoxsalen as first-line treatment of patients with moderate to severe cGVHD. (Pubmed Central) -  Jul 8, 2020   
    P1
    Adult patients with new-onset (≤3 years of hematopoietic stem cell transplantation) moderate or severe cGVHD were randomized 1:1 to 26 weeks of SoC+ECP vs SoC (corticosteroids and cyclosporine A/tacrolimus) between 2011 and 2015...The encouraging short-term results of this study could inform the design of subsequent studies. This trial was registered at www.clinicaltrials.gov as #NCT01380535.
  • ||||||||||  Uvadex/Therakos Photopheresis (methoxsalen/ECP) / Mallinckrodt
    Trial completion date, Trial primary completion date:  PROMPT: Study of Photopheresis in the Treatment of Erythrodermic MF and SS (clinicaltrials.gov) -  Nov 19, 2019   
    P2,  N=46, Not yet recruiting, 
    Clinical Trial Registry: Name of the Clinical Trial Registry: Clincatrials.gov Trial registration number: NCT02524847 Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Sep 2021 --> Sep 2022