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

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Polish Lymphoma Research Group
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Methotrexate

Criteria

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