Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-01-13 @ 7:52 AM
Study NCT ID:
NCT00035867
Status:
COMPLETED
Last Update Posted:
2008-06-03
First Post:
2002-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'statusVerifiedDate': '2005-06', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-30', 'studyFirstSubmitDate': '2002-05-06', 'studyFirstSubmitQcDate': '2002-05-06', 'lastUpdatePostDateStruct': {'date': '2008-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-05-07', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Myelodysplastic Syndromes']}, 'referencesModule': {'references': [{'pmid': '19439093', 'type': 'DERIVED', 'citation': 'Raza A, Galili N, Callander N, Ochoa L, Piro L, Emanuel P, Williams S, Burris H 3rd, Faderl S, Estrov Z, Curtin P, Larson RA, Keck JG, Jones M, Meng L, Brown GL. Phase 1-2a multicenter dose-escalation study of ezatiostat hydrochloride liposomes for injection (Telintra, TLK199), a novel glutathione analog prodrug in patients with myelodysplastic syndrome. J Hematol Oncol. 2009 May 13;2:20. doi: 10.1186/1756-8722-2-20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and efficacy of TLK199 in patients with myelodysplastic syndrome (MDS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of MDS\n* Adequate liver and kidney function\n* Ineligible for, or refusing, allogeneic bone marrow transplant\n* At least 18 years of age\n* Discontinuation of growth factors (e.g., G- CSF) at least 2 weeks prior to study entry\n\nExclusion Criteria:\n\n* Failure to recover from any prior surgery, or any major surgery within 4 weeks of study entry\n* Pregnant or lactating women\n* History of allergy to eggs\n* Other investigational drugs within 14 days of study entry\n* Chemotherapy, radiotherapy or immunotherapy within 14 days of study entry\n* Concomitant steroids or hormones for the treatment of neoplasms'}, 'identificationModule': {'nctId': 'NCT00035867', 'briefTitle': 'Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Telik'}, 'officialTitle': 'Phase 1-2a Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome', 'orgStudyIdInfo': {'id': 'TLK199.1001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'TLK199 HCl Liposomes for Injection', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90404', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'The Angeles Clinic & Research Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60077', 'city': 'Skokie', 'state': 'Illinois', 'country': 'United States', 'facility': 'Midwest Cancer Research Group', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The Sarah Cannon Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Cancer Associates', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M.D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Telik', 'class': 'INDUSTRY'}}}}