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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Methotrexate 20mg per dose, administered orally, once every week
Interferon Alfa-2b 3 million international units (MIU), administered 3 times per week
Centrum Onkologii im. prof. F. Łukaszczyka
Bydgoszcz, Poland
Objective response rate as measured by the modified Severity Weighted Assessment Tool (mSWAT scoring system)
Evaluation according to modified Severity Weighted Assessment Tool (mSWAT scoring system)
Time frame: 3 years
Number of Participants With Adverse Events
Time frame: 3 years
Quality of Life as measured by the Dermatology Life Quality Index (DLQI)
Evaluation according to Dermatology Life Quality Index (DLQI)
Time frame: 3 years
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