Clinical trial NCT02323659: Comparison of Methotrexate Versus Interferon-alfa 2b in Patients With Primary Cutaneous T-cell Lymphomas
Official title: Comparison of Methotrexate Versus Interferon-alfa 2b on Efficacy, Safety and Quality of Life in Patients With Primary Cutaneous T-cell Lymphomas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Lymphoma, T-Cell, Cutaneous
Mycosis Fungoides
Keywords: Mycosis Fungoides
Cutaneous T-Cell Lymphoma
Interferon
Methotrexate
Lead sponsor: Polish Lymphoma Research Group
Sponsor class: NETWORK
First posted: 2014-12-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Objective response rate as measured by the modified Severity Weighted Assessment Tool (mSWAT scoring system)
timeFrame: 3 years
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 3 years
measure: Quality of Life as measured by the Dermatology Life Quality Index (DLQI)
timeFrame: 3 years
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. prof. F. Łukaszczyka
Study officials:
affiliation: Polish Lymphoma Research Group
name: Małgorzata Sokołowska Wojdyło, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Polish Lymphoma Research Group
name: Ewa Chmielowska, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.