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

December 23, 2021 updated by: Polish Lymphoma Research Group

Comparison of Methotrexate Versus Interferon-alfa 2b on Efficacy, Safety and Quality of Life 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 after failure of topical or phototherapy treatment.

Study Overview

Status

Terminated

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Bydgoszcz, Poland, 85-796
        • Centrum Onkologii im. prof. F. Łukaszczyka

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically confirmed primary cutaneous T-cell lymphoma (CTCL)
  2. Age ≥ 18 years
  3. Performance status WHO<=2
  4. Subject must have adequate bone marrow, renal and hepatic function
  5. Topical and phototherapy treatment failure in the past
  6. Signed informed consent

Exclusion Criteria:

  1. Subject has received prior systemic methotrexate or interferon therapy
  2. Unacceptable methotrexate or interferon treatment toxicity in the past

  3. Inadequate bone marrow, renal or hepatic function as follows:

    • Bone Marrow: Absolute neutrophil count (ANC) < 1,500/mm 3 (1.5 × 10 9 /L); Platelets <100,000/mm 3 (100 × 10 9 /L); Hemoglobin < 9.0 g/dL (1.4 mmol/L);
    • Renal function: Creatinine >1.5 x Upper limit of normal (ULN)
    • Hepatic function: Aspartate and Alanine transaminase (AST and ALT) >3× ULN; bilirubin > 1.5 × ULN
    • Active hepatitis B or hepatitis C
  4. anorexia
  5. major depression with suicidal ideation or suicide attempt in the past
  6. Symptomatic congestive heart failure
  7. Epilepsia or other symptomatic central nervous system dysfunction
  8. active skin infection not related to underlying CTCL, active Tuberculosis, HIV infection
  9. Subject is pregnant or lactating
  10. Psychiatric illness/social situation that would limit compliance with study requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Methotrexate arm
Patients assigned to receive methotrexate
Drug: Methotrexate
Methotrexate 20mg per dose, administered orally, once every week
Other Names:
  • Tranxene
Active Comparator: Interferon Alfa-2b
Patients assigned to receive Interferon alfa 2b
Drug: Interferon Alfa-2b
Interferon Alfa-2b 3 million international units (MIU), administered 3 times per week
Other Names:
  • Intron A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events
Time Frame: 3 years
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)
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 31, 2018

Study Registration Dates

First Submitted

December 12, 2014

First Submitted That Met QC Criteria

December 22, 2014

First Posted (Estimate)

December 23, 2014

Study Record Updates

Last Update Posted (Actual)

January 13, 2022

Last Update Submitted That Met QC Criteria

December 23, 2021

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLRG-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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