Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-27 @ 10:05 PM
Study NCT ID:
NCT01513603
Status:
UNKNOWN
Last Update Posted:
2012-01-20
First Post:
2012-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Cladribine, Cytarabine, Mitoxantrone, Filgrastim (CLAG-M) in Relapsed Acute Lymphoblastic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}], 'ancestors': [{'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': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017338', 'term': 'Cladribine'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D008942', 'term': 'Mitoxantrone'}], 'ancestors': [{'id': 'D015762', 'term': '2-Chloroadenosine'}, {'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003839', 'term': 'Deoxyadenosines'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D000880', 'term': 'Anthraquinones'}, {'id': 'D000095322', 'term': 'Anthrones'}, {'id': 'D000873', 'term': 'Anthracenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-01-19', 'studyFirstSubmitDate': '2012-01-11', 'studyFirstSubmitQcDate': '2012-01-19', 'lastUpdatePostDateStruct': {'date': '2012-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete remission percentage', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Lymphoblastic Leukemia', 'Lymphoblastic Lymphoma', 'Burkitts Leukemia/Lymphoma', 'Chronic Myelogenous Leukemia']}, 'descriptionModule': {'briefSummary': 'CLAG-M is an active, well tolerated regimen in acute myelogenous leukemia. Each of the agents is active in Acute Lymphoblastic Leukemia (ALL) as well. The current trial will determine the efficacy of the regimen in patients with relapsed ALL.', 'detailedDescription': 'Patients will receive standard dose CLAG-M (cladribine, cytarabine, mitoxantrone, filgrastim). Standard support care will be given. Efficacy will be assessed through bone marrow examinations and blood tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Relapsed or refractory acute lymphoblastic leukemia,\n* Burkitts leukemia/lymphoma,\n* Lymphoid blastic CML,\n* Lymphoblastic lymphoma.'}, 'identificationModule': {'nctId': 'NCT01513603', 'briefTitle': 'Trial of Cladribine, Cytarabine, Mitoxantrone, Filgrastim (CLAG-M) in Relapsed Acute Lymphoblastic Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'New York Medical College'}, 'officialTitle': 'Phase II Trial of CLAG-M in Relapsed ALL', 'orgStudyIdInfo': {'id': 'L-10,442'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CLAG-M', 'interventionNames': ['Drug: CLAG-M']}], 'interventions': [{'name': 'CLAG-M', 'type': 'DRUG', 'otherNames': ['Leustatin', 'Ara-C', 'Novantrone'], 'description': 'IV times 5 days', 'armGroupLabels': ['CLAG-M']}, {'name': 'CLAG-M', 'type': 'DRUG', 'otherNames': ['Cladribine (Leustatin)', 'Cytarabine (Ara-c)', 'Mitoxantrone (Novantrone)'], 'description': 'Chemotherapy', 'armGroupLabels': ['CLAG-M']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Karen Seiter, MD', 'role': 'CONTACT', 'email': 'karen_seiter@nymc.edu', 'phone': '914-493-7514'}, {'name': 'Karen Seiter, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Delong Liu, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Claudio Sandoval, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Westchester Medical Center/New York Medical College', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}], 'centralContacts': [{'name': 'Karen Seiter, MD', 'role': 'CONTACT', 'email': 'karen_seiter@nymc.edu', 'phone': '914 493 7514'}, {'name': 'Nasir Ahmed, MD', 'role': 'CONTACT', 'email': 'nasir_ahmed@nymc.edu', 'phone': '914 493 7514'}], 'overallOfficials': [{'name': 'Karen Seiter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Karen Seiter', 'investigatorAffiliation': 'New York Medical College'}}}}