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

Mycosis Fungoides Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02323659
• Other study ID #: PLRG-14
• Status: Terminated
• Phase: Phase 4
• Start date: June 1, 2014
• Est. completion date: March 31, 2018

Study information

• Verified date: October 2018
• Source: Polish Lymphoma Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: March 31, 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Mycoses
• Mycosis Fungoides

Intervention

Drug:
• Methotrexate
Methotrexate 20mg per dose, administered orally, once every week
• Interferon Alfa-2b
Interferon Alfa-2b 3 million international units (MIU), administered 3 times per week

Locations

Country	Name	City	State
Poland	Centrum Onkologii im. prof. F. Lukaszczyka	Bydgoszcz

Sponsors (1)

Lead Sponsor	Collaborator
Polish Lymphoma Research Group

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Adverse Events		3 years
Secondary	Quality of Life as measured by the Dermatology Life Quality Index (DLQI)	Evaluation according to Dermatology Life Quality Index (DLQI)	3 years