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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides

Intervention / Treatment
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* Drug: Methotrexate
* Drug: Interferon Alfa-2b


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed primary cutaneous T-cell lymphoma (CTCL) Age ≥ 18 years Performance status WHO<=2 Subject must have adequate bone marrow, renal and hepatic function Topical and phototherapy treatment failure in the past Signed informed consent Exclusion Criteria: Subject has received prior systemic methotrexate or interferon therapy Unacceptable methotrexate or interferon treatment toxicity in the past 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 anorexia major depression with suicidal ideation or suicide attempt in the past Symptomatic congestive heart failure Epilepsia or other symptomatic central nervous system dysfunction active skin infection not related to underlying CTCL, active Tuberculosis, HIV infection Subject is pregnant or lactating Psychiatric illness/social situation that would limit compliance with study requirements

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate as measured by the modified Severity Weighted Assessment Tool (mSWAT scoring system) | 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 |  | 3 years | 
| Quality of Life as measured by the Dermatology Life Quality Index (DLQI) | Evaluation according to Dermatology Life Quality Index (DLQI) | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mycosis Fungoides, Cutaneous T-Cell Lymphoma, Interferon, Methotrexate