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Prospective, Randomized Multicentic to Compare PUVA+IFN Alpha 2a vs PUVA Alone in Mycosis Fungoides Stages Ia, Ib or IIa.


Phase 4
18 Years
70 Years
Not Enrolling
Both
Cutaneous T-Cell Lymphoma (Mycosis Fungoides)

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Trial Information

Prospective, Randomized Multicentic to Compare PUVA+IFN Alpha 2a vs PUVA Alone in Mycosis Fungoides Stages Ia, Ib or IIa.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy of PUVA vs PUVA + IFN

Outcome Time Frame:

Weeks 4, 8, 12, 16 and 24

Safety Issue:

Yes

Principal Investigator

Francisco Vanaclocha Sebastián, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital 12 de Octubre

Authority:

Spain: Spanish Agency of Medicines

Study ID:

MF99

NCT ID:

NCT00630903

Start Date:

January 2000

Completion Date:

Related Keywords:

  • Cutaneous T-Cell Lymphoma (Mycosis Fungoides)
  • Lymphoma
  • Mycoses
  • Mycosis Fungoides
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous

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