Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-29 @ 12:16 AM
Study NCT ID:
NCT01459159
Status:
TERMINATED
Last Update Posted:
2013-11-25
First Post:
2011-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of (Telintra®) in Non-Del(5q) 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': 'C096329', 'term': 'gamma-Glu-S-BzCys-PhGly diethyl ester'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 162}}, 'statusModule': {'whyStopped': 'Study TLK199.2108 was terminated for business reasons.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-20', 'studyFirstSubmitDate': '2011-10-11', 'studyFirstSubmitQcDate': '2011-10-21', 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hematologic Improvement-Erythroid (HI-E) rate', 'timeFrame': 'At 8 weeks of treatment', 'description': 'Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)'}, {'measure': 'Hematologic Improvement-Erythroid (HI-E) rate', 'timeFrame': 'At 16 weeks of treatment', 'description': 'Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)'}, {'measure': 'Hematologic Improvement-Erythroid (HI-E) rate', 'timeFrame': 'At 24 weeks of treatment', 'description': 'Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)'}, {'measure': 'Hematologic Improvement-Erythroid (HI-E) rate', 'timeFrame': 'At 32 weeks of treatment', 'description': 'Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)'}], 'secondaryOutcomes': [{'measure': 'RBC Transfusion independence (TI) rate', 'timeFrame': 'At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment'}, {'measure': 'Hematologic Improvement-Neutrophil (HI-N) rate', 'timeFrame': 'At 8, 16, 24, & 32 weeks of treatment', 'description': 'Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)'}, {'measure': 'Hematologic Improvement-Platelet (HI-P) rate', 'timeFrame': 'At 8, 16, 24, & 32 weeks of treatment', 'description': 'Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)'}, {'measure': 'Unilineage, bilineage, trilineage, and overall HI response rate', 'timeFrame': '2 years'}, {'measure': 'Cytogenetic response rate', 'timeFrame': '16 weeks, 48 weeks and at the time of first HI response'}, {'measure': 'Duration of response', 'timeFrame': '2 years'}, {'measure': 'Safety of ezatiostat in this MDS population', 'timeFrame': 'At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment', 'description': 'Recording and grading of AEs using NCI-CTCAE v4.03'}, {'measure': 'Evaluation of the relationship between HI-E response, gene expression profiling and response-related variables', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hematology', 'MDS', 'Myelodysplastic Syndrome', 'Low risk MDS', 'Int-1 risk MDS', 'Transfusion dependence', 'Telintra', 'ezatiostat', 'ezatiostat hydrochloride', 'TLK199', 'Glutathione', 'Glutathione analog', 'Glutathione Transferase', 'Glutathione Transferase P1-1 inhibitor', 'GST P1-1 inhibitor', 'Apoptosis', 'Differentiation', 'Enzyme inhibitor', 'non-del (5q)', 'non-deletion 5q'], 'conditions': ['Myelodysplastic Syndrome (MDS)']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, single arm open label Phase 2b Study of oral ezatiostat (Telintra®) in Patients who are RBC tranfusion dependent, Low to INT-1 IPSS risk, non-del (5q) Myelodysplastic Syndrome (MDS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary or de Novo MDS\n* Low to Intermediate-1 IPSS risk of MDS\n* ECOG performance score of 0 or 1\n* Documentation of significant anemia with or without additional cytopenia\n* Adequate kidney and liver function\n* Patients must have discontinued hematopoietic growth factors at least 3 weeks prior to study entry\n\nExclusion Criteria:\n\n* Deletion of the 5q chromosome \\[del(5q) MDS\\]\n* Prior allogenic bone marrow transplant for MDS\n* Known sensitivity to ezatiostat (injection or oral tablets)\n* Prior treatment with hypomethylating agent (HMA) (e.g., azacitadine, decitabine)\n* History of MDS IPSS risk score of greater than 1.0\n* Pregnant or lactating women\n* Any severe concurrent disease, infection or comorbidity that, in the judgement of the investigator, would make the patient inappropriate for study entry\n* Oral steroids greater than 10 mg per day. Exceptions: those prescribed for other conditions (such as new adrenal failure, asthma, arthritis) or brief sterioid use (such as tapered dosing for an acute non-MDS condition)\n* History of hepatitis B or C, or HIV'}, 'identificationModule': {'nctId': 'NCT01459159', 'briefTitle': 'Study of (Telintra®) in Non-Del(5q) Myelodysplastic Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Telik'}, 'officialTitle': 'Phase 2b Study of Oral Ezatiostat Hydrochloride (Telintra®) in Patients With Low to Intermediate-1 Risk, Non-Deletion 5q Myelodysplastic Syndrome', 'orgStudyIdInfo': {'id': 'TLK199.2108'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ezatiostat hydrochloride (Telintra®)', 'type': 'DRUG', 'otherNames': ['Telintra', 'Telintra Tablets', 'Oral Telintra', 'ezatiostat', 'ezatiostat hydrochloride', 'oral ezatiostat'], 'description': 'Three weeks of treatment with ezatiostat at 2000 mg per day in divided doses followed by a one week rest period in four-week treatment cycles.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'Bay Area Cancer Research Group', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '62794', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'SIU School of Medicine, Simmons Cancer Institute', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Center for Cancer and Blood Disorders', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The West Clinic', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Gail L Brown, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Telik'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Telik', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}