Clinical Trial: Comparison of Methotrexate Versus Interferon-alfa 2b in Patients With Primary Cutaneous T-cell Lymphomas

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Comparison of Methotrexate Versus Interferon-alfa 2b on Efficacy, Safety and Quality of Life in Patients With Primary Cutaneous T-cell Lymphomas

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Polish Lymphoma Research Group

Current Primary Outcome: Objective response rate as measured by the modified Severity Weighted Assessment Tool (mSWAT scoring system) [ Time Frame: 3 years ]

Evaluation according to modified Severity Weighted Assessment Tool (mSWAT scoring system)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of Participants With Adverse Events [ Time Frame: 3 years ]
  • Quality of Life as measured by the Dermatology Life Quality Index (DLQI) [ Time Frame: 3 years ]
    Evaluation according to Dermatology Life Quality Index (DLQI)


Original Secondary Outcome: Same as current

Information By: Polish Lymphoma Research Group

Dates:
Date Received: December 12, 2014
Date Started: June 2014
Date Completion: May 2017
Last Updated: February 21, 2017
Last Verified: February 2016