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Comparison of methotrexate versus interferon-alfa 2b on efficacy, safety and quality of life in patients with primary cutaneous T-cell lymphomas after failure of topical or phototherapy treatment.
Full description
Methotrexate and interferon are widely used drugs in treatment in patients with cutaneous T-cell Lymphomas. Efficacy and safety of both drugs have never been compared directly in one study.
Patients will be randomly assigned to receive Methotrexate or Interferon Alfa 2b. Treatment will continue until disease progression or the development of intolerable toxicities. Study is conducted to analyse and compare efficacy, safety and quality of life provided by Methotrexate or Interferon Alfa 2b.
Enrollment
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Inclusion criteria
Exclusion criteria
Subject has received prior systemic methotrexate or interferon therapy
Unacceptable methotrexate or interferon treatment toxicity in the past
Inadequate bone marrow, renal or hepatic function as follows:
anorexia
major depression with suicidal ideation or suicide attempt in the past
Symptomatic congestive heart failure
Epilepsia or other symptomatic central nervous system dysfunction
active skin infection not related to underlying CTCL, active Tuberculosis, HIV infection
Subject is pregnant or lactating
Psychiatric illness/social situation that would limit compliance with study requirements
Primary purpose
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Interventional model
Masking
100 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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