Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-28 @ 12:08 AM
Study NCT ID:
NCT00098033
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2004-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Clofarabine in Acute Leukemias
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D015465', 'term': 'Leukemia, Myeloid, Accelerated Phase'}, {'id': 'D001752', 'term': 'Blast Crisis'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'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': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002471', 'term': 'Cell Transformation, Neoplastic'}, {'id': 'D063646', 'term': 'Carcinogenesis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077866', 'term': 'Clofarabine'}], 'ancestors': [{'id': 'D000227', 'term': 'Adenine Nucleotides'}, {'id': 'D011685', 'term': 'Purine Nucleotides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09'}, 'statusVerifiedDate': '2004-12', 'completionDateStruct': {'date': '2005-09'}, 'lastUpdateSubmitDate': '2015-03-24', 'studyFirstSubmitDate': '2004-12-02', 'studyFirstSubmitQcDate': '2004-12-02', 'lastUpdatePostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-12-03', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['clinical', 'pharmacodynamics', 'investigational drug clofarabine', 'AML, ALL, CML-accelerated phase, CML-blastic phase', 'Chronic Myelogenous Leukemia - accelerated phase', 'Chronic Myelogenous Leukemia - blastic phase'], 'conditions': ['Acute Myelogenous Leukemia', 'Acute Lymphocytic Leukemia', 'Chronic Myelogenous Leukemia']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Cortes JE, Gandhi V, et al. Clofarabine (2-chloro-9-(deoxy-2-fluoro-b-D-arabinosfuranosyl)adenine) is active for patients with refractory or relapsed acute leukemia. #739 ASH 2002.'}], 'seeAlsoLinks': [{'url': 'http://www.clinicaltrials.gov', 'label': "FDA's clinical trials website"}]}, 'descriptionModule': {'briefSummary': 'The goals and objectives of this project are to evaluate the antileukemic activity of the investigational agent clofarabine in patients with acute myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), and chronic myelogenous leukemia (CML) in accelerated and blastic phases.', 'detailedDescription': 'The specific aims of the project are (1) conduct the phase II study of clofarabine and evaluate the antileukemic efficacy in AML, ALL, and CML-accelerated and blastic phases in terms of complete response (CR) rate, response duration, and survival; and (2) analyze the relationship between cellular uptake and retention of clofarabine triphosphate (the active metabolite), inhibition of DNA synthesis, and clinical outcome.\n\nCompletion date provided represents the completion date of the grant per OOPD records'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Patient is diagnosed with AML, ALL, myelodysplastic syndrome (MDS), and CML in transformation (includes CML-blastic phase and CML-accelerated phase).\n* No prior chemo-, immuno-, or radio-therapy for 2 weeks before entering the study, unless progressive life-threatening leukemia as judged by the treated physician.\n* Adequate liver function (bilirubin \\</= 2 mg%) and renal function (creatinine \\</= 2 mg%).\n* Pregnant and lactating females not eligible.\n* Zubrod performance status 0-2\n* Adequate cardiac status\n* No life-threatening conditions (e.g. infections) which may cause death within 3 weeks.'}, 'identificationModule': {'nctId': 'NCT00098033', 'briefTitle': 'Investigation of Clofarabine in Acute Leukemias', 'organization': {'class': 'FED', 'fullName': 'FDA Office of Orphan Products Development'}, 'officialTitle': 'Phase II Clinical and Pharmacodynamic Investigation of Clofarabine in Acute Leukemias', 'orgStudyIdInfo': {'id': '2127'}}, 'armsInterventionsModule': {'interventions': [{'name': 'clofarabine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Hagop M Kantarjian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}, {'name': 'Jorge E Cortes, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas', 'class': 'OTHER'}}}}