NCT02323659.

Study name	Comparison of methotrexate versus interferon‐alfa 2b on efficacy, safety and quality of life in patients with primary cutaneous T‐cell lymphomas
Methods	This is a randomised, controlled, open‐label trial comparing methotrexate vs. 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
Participants	Inclusion criteria Histologically‐confirmed primary cutaneous T‐cell lymphoma (CTCL) Age ≥ 18 years Topical and phototherapy treatment failure in the past Exclusion criteria Participant has received prior systemic methotrexate or interferon therapy Unacceptable methotrexate or interferon treatment toxicity in the past
Interventions	Arm I Methotrexate 20 mg per dose, administered orally, once every week Arm II Interferon Alfa‐2b 3 million international units (MIU), administered 3 times per week
Outcomes	Primary outcome of the trial Objective response rate as measured by the modified Severity Weighted Assessment Tool (mSWAT scoring system) Evaluation according to mSWAT scoring system Secondary outcomes of the trial Number of participants with adverse events Quality of Life as measured by the Dermatology Life Quality Index (DLQI) Evaluation according to Dermatology Life Quality Index (DLQI)
Starting date	June 2014
Contact information	Sponsors and collaborators Polish Lymphoma Research Group Investigators Principal Investigator: Małgorzata Sokołowska Wojdyło, MD, PhD Polish Lymphoma Research Group Principal Investigator: Ewa Chmielowska, MD, PhD Polish Lymphoma Research Group
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