Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-28 @ 1:05 PM
Study NCT ID:
NCT00086203
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2004-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Talabostat and Rituximab in Advanced Chronic Lymphocytic Leukemia (CLL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C477478', 'term': 'PT-100 dipeptide'}, {'id': 'C514044', 'term': 'talabostat'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'statusVerifiedDate': '2006-08', 'completionDateStruct': {'date': '2007-09'}, 'lastUpdateSubmitDate': '2015-03-24', 'studyFirstSubmitDate': '2004-06-28', 'studyFirstSubmitQcDate': '2004-06-28', 'lastUpdatePostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-06-29', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Chronic Lymphocytic Leukemia']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the efficacy and safety of talabostat and rituximab in patients with advanced CLL who failed to respond, or have progressed following a prior response, to a fludarabine regimen.', 'detailedDescription': 'Completion date provided represents the completion date of the grant per OOPD records'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "INCLUSION CRITERIA:\n\n* Men or women ≥18 years of age\n* Histopathologically confirmed diagnosis of B-CLL expressing surface CD20 of any detectable intensity\n* Rai Stage III or IV. Rai Stages I and II with massive or progressive lymphadenopathy or hepatosplenomegaly.\n* Primary resistance to a fludarabine regimen (no PR or CR) or progressive disease within 1 year of a prior response\n* ECOG performance status 0, 1, or 2\n* Written informed consent\n\nEXCLUSION CRITERIA:\n\n* Therapy for CLL within 4 weeks of Study Day 1 (including chemotherapy, radiation, immunotherapy, cytokine or biologic \\[with the exception of hematopoietic growth factors\\]). Patients must have recovered from the adverse effects of prior therapy.\n* Known primary or secondary malignancy of the central nervous system\n* Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix\n* Serum creatinine \\>2.0mg/dL (\\>176 micromol/L)\n* AST or ALT ≥3 x the upper limit of normal (ULN)\n* Total bilirubin ≥1.5 x ULN (unless secondary to Gilbert's)\n* Positive serology for hepatitis B (HBsAg) or hepatitis C (anti-HCV antibody)\n* Known positivity for HIV\n* Prior organ allograft\n* Concurrent comorbid medical conditions that, in the opinion of the investigator, preclude the safe delivery of the experimental treatment\n* Pregnant or nursing women"}, 'identificationModule': {'nctId': 'NCT00086203', 'briefTitle': 'Study of Talabostat and Rituximab in Advanced Chronic Lymphocytic Leukemia (CLL)', 'organization': {'class': 'FED', 'fullName': 'FDA Office of Orphan Products Development'}, 'orgStudyIdInfo': {'id': 'PTH-203'}, 'secondaryIdInfos': [{'id': 'FD-R-003021-01'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Talabostat mesylate (PT-100) tablets', 'type': 'DRUG'}, {'name': 'Rituximab', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Science', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '34474', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Ocala Oncology Center', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '33705', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Gulfcoast Oncology Associates', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Oncology/Hematology Consultants', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '59101', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'Hematology/Oncology Centers of the Northern Rockies', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '89135', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Nevada Cancer Institute', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '11365', 'city': 'Fresh Meadows', 'state': 'New York', 'country': 'United States', 'facility': 'Queens Medical Associates, PC', 'geoPoint': {'lat': 40.73482, 'lon': -73.79347}}, {'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Jewish Medical Center', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'James P. Wilmot Cancer Center/University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27511', 'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Raleigh Hematology/Oncology Clinic', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Cancer Care Associates/Oklahoma City', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '74136', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Cancer Care Associates--Tulsa', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '29672', 'city': 'Seneca', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Cancer Centers of the Carolinas', 'geoPoint': {'lat': 34.68566, 'lon': -82.9532}}, {'zip': '79606-5208', 'city': 'Abilene', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Cancer Center/Abilene', 'geoPoint': {'lat': 32.44874, 'lon': -99.73314}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Oncology Associates-Lake Wright Cancer Center', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Point Therapeutics', 'class': 'INDUSTRY'}}}}