Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides
Conditions
Keywords
Mycosis Fungoides, Cutaneous T-Cell Lymphoma, Interferon, Methotrexate
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.
Interventions
DRUGMethotrexate
Methotrexate 20mg per dose, administered orally, once every week
DRUGInterferon Alfa-2b
Interferon Alfa-2b 3 million international units (MIU), administered 3 times per week
Sponsors
Polish Lymphoma Research Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Poland
Outcome results
None listed