- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02323659
Comparison of Methotrexate Versus Interferon-alfa 2b in Patients With Primary Cutaneous T-cell Lymphomas
Comparison of Methotrexate Versus Interferon-alfa 2b on Efficacy, Safety and Quality of Life in Patients With Primary Cutaneous T-cell Lymphomas
Study Overview
Status
Conditions
Intervention / 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Bydgoszcz, Poland, 85-796
- Centrum Onkologii im. prof. F. Łukaszczyka
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically confirmed primary cutaneous T-cell lymphoma (CTCL)
- Age ≥ 18 years
- Performance status WHO<=2
- Subject must have adequate bone marrow, renal and hepatic function
- Topical and phototherapy treatment failure in the past
- Signed informed consent
Exclusion Criteria:
- Subject has received prior systemic methotrexate or interferon therapy
- Unacceptable methotrexate or interferon treatment toxicity in the past
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
- anorexia
- major depression with suicidal ideation or suicide attempt in the past
- Symptomatic congestive heart failure
- Epilepsia or other symptomatic central nervous system dysfunction
- active skin infection not related to underlying CTCL, active Tuberculosis, HIV infection
- Subject is pregnant or lactating
- Psychiatric illness/social situation that would limit compliance with study requirements
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Methotrexate arm
Patients assigned to receive methotrexate
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Methotrexate 20mg per dose, administered orally, once every week
Other Names:
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Active Comparator: Interferon Alfa-2b
Patients assigned to receive Interferon alfa 2b
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Interferon Alfa-2b 3 million international units (MIU), administered 3 times per week
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate as measured by the modified Severity Weighted Assessment Tool (mSWAT scoring system)
Time Frame: 3 years
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Evaluation according to modified Severity Weighted Assessment Tool (mSWAT scoring system)
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3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events
Time Frame: 3 years
|
3 years
|
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Quality of Life as measured by the Dermatology Life Quality Index (DLQI)
Time Frame: 3 years
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Evaluation according to Dermatology Life Quality Index (DLQI)
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3 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Małgorzata Sokołowska Wojdyło, MD, PhD, Polish Lymphoma Research Group
- Principal Investigator: Ewa Chmielowska, MD, PhD, Polish Lymphoma Research Group
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Bacterial Infections and Mycoses
- Lymphoma
- Mycoses
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Lymphoma, T-Cell, Cutaneous
- Mycosis Fungoides
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Interferons
- Interferon-alpha
- Interferon alpha-2
- Methotrexate
Other Study ID Numbers
- PLRG-14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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