Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-24 @ 3:03 PM
Study NCT ID:
NCT02323659
Status:
TERMINATED
Last Update Posted:
2022-01-13
First Post:
2014-12-12
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Methotrexate Versus Interferon-alfa 2b in Patients With Primary Cutaneous T-cell Lymphomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}, {'id': 'D009182', 'term': 'Mycosis Fungoides'}], 'ancestors': [{'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D003009', 'term': 'Clorazepate Dipotassium'}, {'id': 'D000077190', 'term': 'Interferon alpha-2'}, {'id': 'D007438', 'term': 'Introns'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D016898', 'term': 'Interferon-alpha'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D021901', 'term': 'DNA, Intergenic'}, {'id': 'D040481', 'term': 'Genome Components'}, {'id': 'D016678', 'term': 'Genome'}, {'id': 'D040342', 'term': 'Genetic Structures'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D040461', 'term': 'Gene Components'}, {'id': 'D005796', 'term': 'Genes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'whyStopped': 'Slow recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-23', 'studyFirstSubmitDate': '2014-12-12', 'studyFirstSubmitQcDate': '2014-12-22', 'lastUpdatePostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate as measured by the modified Severity Weighted Assessment Tool (mSWAT scoring system)', 'timeFrame': '3 years', 'description': 'Evaluation according to modified Severity Weighted Assessment Tool (mSWAT scoring system)'}], 'secondaryOutcomes': [{'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', 'description': 'Evaluation according to Dermatology Life Quality Index (DLQI)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mycosis Fungoides', 'Cutaneous T-Cell Lymphoma', 'Interferon', 'Methotrexate'], 'conditions': ['Lymphoma, T-Cell, Cutaneous', 'Mycosis Fungoides']}, 'referencesModule': {'references': [{'pmid': '32632956', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically confirmed primary cutaneous T-cell lymphoma (CTCL)\n2. Age ≥ 18 years\n3. Performance status WHO\\<=2\n4. Subject must have adequate bone marrow, renal and hepatic function\n5. Topical and phototherapy treatment failure in the past\n6. Signed informed consent\n\nExclusion Criteria:\n\n1. Subject has received prior systemic methotrexate or interferon therapy\n2. Unacceptable methotrexate or interferon treatment toxicity in the past\n3. Inadequate bone marrow, renal or hepatic function as follows:\n\n * 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);\n * Renal function: Creatinine \\>1.5 x Upper limit of normal (ULN)\n * Hepatic function: Aspartate and Alanine transaminase (AST and ALT) \\>3× ULN; bilirubin \\> 1.5 × ULN\n * Active hepatitis B or hepatitis C\n4. anorexia\n5. major depression with suicidal ideation or suicide attempt in the past\n6. Symptomatic congestive heart failure\n7. Epilepsia or other symptomatic central nervous system dysfunction\n8. active skin infection not related to underlying CTCL, active Tuberculosis, HIV infection\n9. Subject is pregnant or lactating\n10. Psychiatric illness/social situation that would limit compliance with study requirements'}, 'identificationModule': {'nctId': 'NCT02323659', 'briefTitle': 'Comparison of Methotrexate Versus Interferon-alfa 2b in Patients With Primary Cutaneous T-cell Lymphomas', 'organization': {'class': 'NETWORK', 'fullName': 'Polish Lymphoma Research Group'}, 'officialTitle': 'Comparison of Methotrexate Versus Interferon-alfa 2b on Efficacy, Safety and Quality of Life in Patients With Primary Cutaneous T-cell Lymphomas', 'orgStudyIdInfo': {'id': 'PLRG-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Methotrexate arm', 'description': 'Patients assigned to receive methotrexate', 'interventionNames': ['Drug: Methotrexate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Interferon Alfa-2b', 'description': 'Patients assigned to receive Interferon alfa 2b', 'interventionNames': ['Drug: Interferon Alfa-2b']}], 'interventions': [{'name': 'Methotrexate', 'type': 'DRUG', 'otherNames': ['Tranxene'], 'description': 'Methotrexate 20mg per dose, administered orally, once every week', 'armGroupLabels': ['Methotrexate arm']}, {'name': 'Interferon Alfa-2b', 'type': 'DRUG', 'otherNames': ['Intron A'], 'description': 'Interferon Alfa-2b 3 million international units (MIU), administered 3 times per week', 'armGroupLabels': ['Interferon Alfa-2b']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85-796', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Centrum Onkologii im. prof. F. Łukaszczyka', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}], 'overallOfficials': [{'name': 'Małgorzata Sokołowska Wojdyło, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Polish Lymphoma Research Group'}, {'name': 'Ewa Chmielowska, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Polish Lymphoma Research Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Polish Lymphoma Research Group', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}