Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT00051012
Status:
COMPLETED
Last Update Posted:
2008-03-05
First Post:
2002-12-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients
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'}, {'id': 'D012751', 'term': 'Sezary Syndrome'}], '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': 'C078456', 'term': 'denileukin diftitox'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1995-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-02-29', 'studyFirstSubmitDate': '2002-12-31', 'studyFirstSubmitQcDate': '2003-01-02', 'lastUpdatePostDateStruct': {'date': '2008-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Rate of Response (ORR), defined as CR + CCR + PR'}], 'secondaryOutcomes': [{'measure': 'Time-to-Treatment Failure'}, {'measure': 'Time-to-Progression'}, {'measure': 'Duration of Response'}]}, 'conditionsModule': {'conditions': ['Lymphoma, T-Cell, Cutaneous', 'Mycosis Fungoides', 'Sezary Syndrome']}, 'referencesModule': {'references': [{'pmid': '23770157', 'type': 'DERIVED', 'citation': 'Duvic M, Geskin L, Prince HM. Duration of response in cutaneous T-cell lymphoma patients treated with denileukin diftitox: results from 3 phase III studies. Clin Lymphoma Myeloma Leuk. 2013 Aug;13(4):377-84. doi: 10.1016/j.clml.2013.02.020. Epub 2013 Jun 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to provide an opportunity for patients who exhibit progressive disease while receiving placebo on the companion 93-04-11 study to receive ONTAK. It is also designed to determine the effectiveness of ONTAK in Cutaneous T-cell Lymphoma (CTCL) patients whose tumors do not express CD25.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient must have been previously enrolled in Protocol 93-04-11 and randomized to the placebo arm; or the patient met all eligibility criteria for protocol 93-04-11 other than the expression of CD25 on CTCL tumor cells.\n* CTCL disease Stage Ia - III.\n* History of less than or equal to 3 previous therapies. Repeated use of the same agent is considered to be 1 therapy unless it is part of a different combination regimen. Only 1 prior combination cytotoxic chemotherapy regimen is permitted. Topical or systemic steroids are not considered a therapy.\n* Patient must have evaluable or measurable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow.\n* No significant pulmonary or cardiac disease. No active CNS, kidney, or liver disease.\n* No systemic infections.\n* ECOG performance status of 0 or 1.\n\nExclusion Criteria:\n\n• The 93-04-14 study is no longer open to subjects previously enrolled in 93-04-10 or 92-04-01.'}, 'identificationModule': {'nctId': 'NCT00051012', 'briefTitle': 'Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients', 'nctIdAliases': ['NCT00005620'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Multicenter Open-Label Study to Evaluate the Safety and Efficacy of DAB389IL-2 in Cutaneous T-Cell Lymphoma (CTCL) Patients Following Protocol 93-04-10, Protocol 93-04-11, or Protocol 92-04-01 or Who Meet the Requirements for Protocol 93-04-11 Except Have Biopsy-Documented CTCL That Does Not Express CD25', 'orgStudyIdInfo': {'id': '93-04-14'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ONTAK', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas, M.D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '2065', 'city': "Saint Leonard's", 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Level 4 Department of Haematology Royal North Shore Hospital'}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Hospital, Department of Haematology', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '4101', 'city': 'South Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Mater Misericordiae Adult Hospital', 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Oncology Haematology Radiation Oncology Unit, Princess Alexandra Hospital', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '3002', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Institute', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': 'A-8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'LKH Universitatsklinikum Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': 'A-1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Allgemeines Krankenhaus der Stadt Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Cross Cancer Centre', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Regional Cancer Center', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Universitatsklinikum Charite', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '91052', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'University of Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '45122', 'city': 'Essen', 'country': 'Germany', 'facility': 'Universitatsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'J.W. Goethe University Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitatskrankenhaus Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '68135', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'Universitatsklinikum Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': 'D-48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'Universitatsklinikum Munster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '80-952', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Medical Academy in Gdansk, Dept. of Hematology', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '93-509', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Regional Oncological Center, Dept. of Chemotherapy', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '20-950', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Klinika Hematoonkologii Akademii Medycznej w Lublinie', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '61-833', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Oddzial Chorob Wewnetrznych i Hematologii', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '02-097', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'The Medical University of Warsaw, Central Clinical Hospital', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-781', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Centrum Onkologii-Instytut im. Marii Sklodoskiej-Curie', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Blokhin Russian Cancer Research Center, RAMS', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Burdenko Main Military Clinical Hospital', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Central Research Institute of Skin and Venereal Diseases', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Haematology Research Center RAMS', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'St. Petersburg Pavlov State Medical University', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '443095', 'city': 'Samara', 'country': 'Russia', 'facility': 'Samara Regional Clinical Hospital', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Universitatsspital Zurich Dermatologische Klinik', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "St. John's Institute of Dermatology", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'City Hospital', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'Southampton General Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'Elyane Lombardy, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ligand Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Inc.', 'class': 'INDUSTRY'}}}}