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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02323659
Recruitment Status : Recruiting
First Posted : December 23, 2014
Last Update Posted : July 17, 2017
Information provided by (Responsible Party):
Polish Lymphoma Research Group

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.

Condition or disease Intervention/treatment Phase
Lymphoma, T-Cell, Cutaneous Mycosis Fungoides Drug: Methotrexate Drug: Interferon Alfa-2b Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Active Comparator: Methotrexate arm
Patients assigned to receive methotrexate
Drug: Methotrexate
Methotrexate 20mg per dose, administered orally, once every week
Other Name: Tranxene

Active Comparator: Interferon Alfa-2b
Patients assigned to receive Interferon alfa 2b
Drug: Interferon Alfa-2b
Interferon Alfa-2b 3 million international units (MIU), administered 3 times per week
Other Name: Intron A

Primary Outcome Measures :
  1. Objective response rate as measured by the modified Severity Weighted Assessment Tool (mSWAT scoring system) [ Time Frame: 3 years ]
    Evaluation according to modified Severity Weighted Assessment Tool (mSWAT scoring system)

Secondary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: 3 years ]
  2. Quality of Life as measured by the Dermatology Life Quality Index (DLQI) [ Time Frame: 3 years ]
    Evaluation according to Dermatology Life Quality Index (DLQI)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02323659

Contact: Ewa Chmielowska, MD, PhD 48523743421

Centrum Onkologii im. prof. F. Łukaszczyka Recruiting
Bydgoszcz, Poland, 85-796
Contact: Ewa Chmielowska, MD, PhD    48523743421   
Sponsors and Collaborators
Polish Lymphoma Research Group
Principal Investigator: Małgorzata Sokołowska Wojdyło, MD, PhD Polish Lymphoma Research Group
Principal Investigator: Ewa Chmielowska, MD, PhD Polish Lymphoma Research Group

Responsible Party: Polish Lymphoma Research Group Identifier: NCT02323659     History of Changes
Other Study ID Numbers: PLRG-14
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Polish Lymphoma Research Group:
Mycosis Fungoides
Cutaneous T-Cell Lymphoma

Additional relevant MeSH terms:
Mycosis Fungoides
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors