Clinical trial · Interventional
PUVA Maintenance Therapy in Mycosis Fungoides
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
NCT01686594CI-TRIAL-00035782M_PUVA_2012completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Patch/Plaque Stage Mycosis Fungoides | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 8-methoxypsoralen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- PUVA maintenance treatment
- description
- Psoralen plus UVA (PUVA) treatment. The patients receive a standardized dose of oral 8-methoxypsoralen (Oxsoralen) 1 hour before UVA exposure
- interventionNames
- Drug: 8-methoxypsoralen
- type
- NO_INTERVENTION
- label
- No maintenance treatment
- description
- observation
Primary outcomes (1)
- measure
- Recurrence after complete remission within 12 months post therapy
- timeFrame
- 12 months after end of therapy
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 82 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathologically documented MF clinical stage IA-IIB (see Table1) confirmed by current or previous diagnostic lesion biopsy * A Karnofsky performance score \> 60 * No previous PUVA treatment * Anti-ds-DNA (antinuclear antibodies) or anti-Ro/La antibodies: negative * Acceptable organ function defined as follows: SGOT (AST) and SGPT (ALT) \< 2.5 times the upper limit of normal for the institution * Creatinine \< 2 times the upper limit of normal for the institution * No evidence of severe cardiac insufficiency (NYHA grade III-IV) * Women of child bearing potential must have a negative serum pregnancy test (ß-HCG) within seven (7) days prior to randomization * Absence of any serious intercurrent illness or infection at time of entry into the study that could interfere with planned treatment * Patients must be willing to accept limiting sun exposure on the day receiving PUVA treatment * Written informed consent Exclusion Criteria: * Pregnancy and Lactation * Photosensitive diseases such as lupus erythematosus or basal cell nevus syndrome * Skin cancer syndromes such as xeroderma pigmentosum or basal cell nevus syndrome
References
Publications (2)
- DERIVEDGraier 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. PMID 32850876
- DERIVEDVieyra-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. PMID 30892603