Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-31 @ 11:20 AM
Study NCT ID:
NCT00083694
Status:
COMPLETED
Last Update Posted:
2010-07-02
First Post:
2004-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013792', 'term': 'Thalidomide'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-08'}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2005-05'}, 'lastUpdateSubmitDate': '2010-07-01', 'studyFirstSubmitDate': '2004-05-27', 'studyFirstSubmitQcDate': '2004-05-28', 'lastUpdatePostDateStruct': {'date': '2010-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the efficacy and safety of Thalidomide in patients with leukemia.'}]}, 'conditionsModule': {'keywords': ['Leukemia', 'Thalidomide', 'relapsed'], 'conditions': ['Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://myeloma.uams.edu', 'label': 'Myeloma Institute for Research \\& Therapy website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of Thalidomide in patients with leukemia.', 'detailedDescription': 'Patients will take Thalidomide tablets at bedtime daily until remission. The dose will be increased gradually and modified according to side-effects. The drug will be given daily up to the time of complete remission then as long as it is beneficial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of refractory or relapsed leukemia: acute leukemia, CML, CLLm and MDS.\n* Signed informed consent, including patient agreeing to use safe contraceptive methods during the treatment and for at least 4 months after the treatment is completed\n* Serum creatinine \\< or = 2.5mg/dL\n* Serum bilirubin\\< or = 2.5mg/dL\n* Negative pregnancy test\n* Age 18 years or older\n* Performance status \\< or = 3\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Concurrent treatment with cytotoxic chemotherapy, or radiation\n* History of seizures, neurotoxicity, or active CNS disease\n* Serious infections not controlled by antibiotics'}, 'identificationModule': {'nctId': 'NCT00083694', 'briefTitle': 'Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'UARK, 98-032, Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia', 'orgStudyIdInfo': {'id': 'UARK 98-032'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Thalidomide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences/MIRT', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Barthel Barlogie, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UAMS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'collaborators': [{'name': 'Celgene Corporation', 'class': 'INDUSTRY'}]}}}