M_PUVA_2012
A Multi-center, Randomized Study on Oral 8-methoxypsoralen Plus UVA With or Without Maintenance Therapy in Mycosis Fungoides EORTC/ISCL Stage IA to IIB
Sponsor study identifier
Secondary identifiers
OTHER · Ethics committee Medical University of Graz
interventional
28
1 country
9
Study Start
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2, 2018
Actual (reported)Study Completion
July 2, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 9, 2012
Actual (reported)September 18, 2012
Actual (reported)February 2013
Date type not reportedThis date has not been verified as actual or estimated.
July 2, 2018
Actual (reported)July 2, 2018
Actual (reported)Recurrence after complete remission within 12 months post therapy
Recurrence is defined as mSWAT (modified severity weighted assessment tool ) \>0. The primary outcome will be evaluated by survival analysis (log-rank test; Kaplan-Meier) comparing time to recurrence after complete remission between patients treated with maintenance therapy vs. patients without maintenance therapy.
12 months after end of therapy
Quality of life
Week -4 to 0; week 12, 24, 36, and 48; month 15, 18, 21, 24, 36, 48, 60, and 72
HADS
Week -4 to 0; week 12, 24, 36, and 48; month 15, 18, 21, 24, 36, 48, 60, and 72
Cytokine response in serum
Week -4 to 0; week 6, 12, 24, and 48
Levels of regulatory T cells
Week -4 to 0; week 6, 12, 24, and 48
Function of regulatory T cells
Week -4 to 0; week 6, 12, 24, and 48
Psoralen plus UVA (PUVA) treatment. The patients receive a standardized dose of oral 8-methoxypsoralen (Oxsoralen) 1 hour before UVA exposure
observation
8-methoxypsoralen 10mg per 20 kg body weight 1 hour before UVA exposure
Medical University of Graz
Graz, 8010, Austria
Department of Dermatology, Medical University of Innsbruck
Innsbruck, A-6020, Austria
Department of Dermatology, General Hospital of the City of Linz
Linz, A-4021, Austria
Department of Dermatology, Hospital Salzburg - Paracelsus Private Medical University
Salzburg, A-5020, Austria
Department of Dermatology, County Hospital St. Pölten
Sankt Pölten, A-3100, Austria
Department of Dermatology, Medical University of Vienna
Vienna, A-1090, Austria
Department of Dermatology, Hospital Hietzing
Graier T, Fink-Puches R, Porkert S, Lang R, Pochlauer S, Ratzinger G, Tanew A, Selhofer S, Sator PG, Hofer A, Gruber-Wackernagel A, Legat FJ, Vieyra-Garcia PA, Quehenberger F, Wolf P. Quality of Life, Anxiety, and Depression in Patients With Early-Stage Mycosis Fungoides and the Effect of Oral Psoralen Plus UV-A (PUVA) Photochemotherapy on it. Front Med (Lausanne). 2020 Aug 5;7:330. doi: 10.3389/fmed.2020.00330. eCollection 2020.
Vieyra-Garcia P, Fink-Puches R, Porkert S, Lang R, Pochlauer S, Ratzinger G, Tanew A, Selhofer S, Paul-Gunther S, Hofer A, Gruber-Wackernagel A, Legat F, Patra V, Quehenberger F, Cerroni L, Clark R, Wolf P. Evaluation of Low-Dose, Low-Frequency Oral Psoralen-UV-A Treatment With or Without Maintenance on Early-Stage Mycosis Fungoides: A Randomized Clinical Trial. JAMA Dermatol. 2019 May 1;155(5):538-547. doi: 10.1001/jamadermatol.2018.5905.
Peter Wolf, MD
Medical University of Graz
28 participants (actual enrollment reported by the registry).
First Submitted
May 9, 2012
First Posted
September 18, 2012
Study Start
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Vienna, A-1130, Austria
Department of Dermatology, Klinikum Wels
Wels, A-4600, Austria
Department of Dermatology, County Hospital Wiener Neustadt
Wiener Neustadt, A-2700, Austria
Primary Completion
July 2, 2018
Actual (reported)Study Completion
July 2, 2018
Actual (reported)Last Updated
November 14, 2018
Record last verified: 2018-11
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