NCT02323659

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Polish Lymphoma Research Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Lymphoma, T-Cell, Cutaneous
• Mycosis Fungoides

Interventions

Type	Name	Description
DRUG	Methotrexate	Methotrexate 20mg per dose, administered orally, once every week
DRUG	Interferon Alfa-2b	Interferon Alfa-2b 3 million international units (MIU), administered 3 times per week

Timeline

• Start date: 2014-06-01
• Primary completion: 2018-03-01
• Completion: 2018-03-31
• First posted: 2014-12-23
• Last updated: 2022-01-13

Locations

1 site across 1 country: Poland