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

Phase 4

Terminated

• Conditions: Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides
• Interventions: Drug: Methotrexate; Drug: Interferon Alfa-2b

• Registration Number: NCT02323659
• Lead Sponsor: Polish Lymphoma Research Group

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 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 Timeline

• Study Start: 2014-06-01
• Study First Submitted: 2014-12-12
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-23
• Primary Completion: 2018-03
• Study Completion: 2018-03-31
• Status Verified: 2018-10
• Last Update Submitted: 2021-12-23
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methotrexate arm	Methotrexate	Patients assigned to receive methotrexate
Interferon Alfa-2b	Interferon Alfa-2b	Patients assigned to receive Interferon alfa 2b

Primary Outcome Measures

Name	Time	Method
Objective response rate as measured by the modified Severity Weighted Assessment Tool (mSWAT scoring system)	3 years	Evaluation according to modified Severity Weighted Assessment Tool (mSWAT scoring system)

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	3 years
Quality of Life as measured by the Dermatology Life Quality Index (DLQI)	3 years	Evaluation according to Dermatology Life Quality Index (DLQI)

Trial Locations

Locations (1)

Centrum Onkologii im. prof. F. Łukaszczyka; 🇵🇱 Bydgoszcz, Poland