Clinical trial · Interventional
PUVA Versus PUVA + IFN Alpha 2a in Mycosis Fungoides
Prospective, Randomized Multicentic to Compare PUVA+IFN Alpha 2a vs PUVA Alone in Mycosis Fungoides Stages Ia, Ib or IIa.
NCT00630903CI-TRIAL-00001335MF99terminatedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient accrual
Summary
Brief summary (as posted)
The purpose of this study is to determine if combination of PUVA with interferon alpha is better than PUVA alone to treat mycosis fungoides stage Ia Ib or IIa.
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 |
|---|---|---|---|
| Cutaneous T-Cell Lymphoma (Mycosis Fungoides) | Mycosis Fungoides | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PUVA (8-MOP + UVA) | Drug | — | UNRESOLVED |
| PUVA (8MOP + UVA) + IFN | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- 8-MOP + UVA x 24 weeks
- interventionNames
- Drug: PUVA (8-MOP + UVA)
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- IFN alone, 2 weeks, 8-MOP + UVA irradiation + IFN, 22 weeks
- interventionNames
- Drug: PUVA (8MOP + UVA) + IFN
Primary outcomes (1)
- measure
- Efficacy of PUVA vs PUVA + IFN
- timeFrame
- Weeks 4, 8, 12, 16 and 24
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Mycosis fungoides Stage Ia Ib IIa * Written informed consent * 18-70 y.o., both sex * No concomitant systemic disease Exclusion Criteria: * Pregnant or lactating women * Fertile women not accepting contraception * Medical history of melanoma or non melanoma skin cancer * Concomitant infections * Immunodeficiency states * Previous Heart disease * Respiratory insufficiency * Chronic RRenal insufficiency * Chronic hepatopathy * Epilepsy * Depression * Leucocytes \<3000 or neutrophiles \<1000 or thrombocytes \<100000 or hemoglobin \<12 gr/dL or ANA \<1/80 * Treatment with systemic steroids * Altered thyroid hormones * Previous resistance to PUVA and/or IFN * Hypersensitivity to IFN * Patients under treatment with teophiline and/or dicumarol * Previous total skin electron beam * Wash up period less than 3 month for IFN and /or PUVA * Wash up period less than 1 month for topical treatments
References
Publications (1)
- DERIVEDValipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3. PMID 32632956