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Insufficient accrual
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | 8-MOP + UVA x 24 weeks |
|
| B | Active Comparator | IFN alone, 2 weeks, 8-MOP + UVA irradiation + IFN, 22 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PUVA (8MOP + UVA) + IFN | Drug | Weeks 3-24: 8.MOP: 0.6 MG/K, 3 times a week, 2 hours pre UVA irradiation (1-2 jul/cm2 according to phototype, increasing until 10 Jul/cm2, if tolerated) IFN: week1: 3, 6 and 9 MU (Mon, Wed, Fry). Weeks 2-24: 9MU 3 times a week) |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of PUVA vs PUVA + IFN | Weeks 4, 8, 12, 16 and 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco Vanaclocha Sebastián, MD | Hospital 12 de Octubre | Principal Investigator |
| Jesús Fernández Herrera, MD, PhD | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Príncipe de Asturias. | Alcalá de Henares | Madrid | Spain | |||
| Hospital Universitario de Getafe |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32632956 | Derived | Valipour 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. |
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| ID | Term |
|---|---|
| D009182 | Mycosis Fungoides |
| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
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| ID | Term |
|---|---|
| D008730 | Methoxsalen |
| ID | Term |
|---|---|
| D011564 | Furocoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| PUVA (8-MOP + UVA) | Drug | Weeks 1-24: 8.MOP: 0.6 MG/K, 3 times a week, 2 hours pre UVA irradiation (1-2 jul/cm2 according to phototype, increasing until 10 Jul/cm2, if tolerated) |
|
| Getafe |
| Madrid |
| Spain |
| Hospital de la Princess | Madrid | Madrid | 28009 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Madrid | 28041 | Spain |
| Fundación Jiménez Díaz | Madrid | Madrid | Spain |
| Hospital Clínico San Carlos | Madrid | Madrid | Spain |
| Hospital Gómez Ulla | Madrid | Madrid | Spain |
| Hospital La Paz | Madrid | Madrid | Spain |
| Hospital Ramón y Cajal | Madrid | Madrid | Spain |
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |