Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-01-01 @ 2:26 AM
Study NCT ID:
NCT03518112
Status:
TERMINATED
Last Update Posted:
2022-11-04
First Post:
2018-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Low-Intensity Chemotherapy and Blinatumomab in Treating Patients With Philadelphia Chromosome Negative Relapsed or Refractory Acute Lymphoblastic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002051', 'term': 'Burkitt Lymphoma'}], 'ancestors': [{'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': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C510808', 'term': 'blinatumomab'}, {'id': 'C568788', 'term': 'N,N-dicyclohexyl-isoborneol-10-sulfonamide'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'C059464', 'term': 'auricularum'}, {'id': 'C018038', 'term': 'dexamethasone acetate'}, {'id': 'C004180', 'term': 'dexamethasone 21-phosphate'}, {'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'C488629', 'term': 'azathiopurine'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'C015342', 'term': 'merphos'}, {'id': 'C455861', 'term': 'pegfilgrastim'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'C000626854', 'term': 'CT-P10'}, {'id': 'D014750', 'term': 'Vincristine'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D013438', 'term': 'Sulfhydryl Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'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': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ejabbour@mdanderson.org', 'phone': '713-792-4764', 'title': 'Dr. Elias Joseph Jabbour MD/Professor', 'organization': 'The University of Texas MD Anderson Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Time from the first day of treatment assessed up to 3 years, 1 month', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment (Blinatumomab, Combination Chemotherapy)', 'description': 'See detailed description.\n\nBlinatumomab: Given IV\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IT or IV\n\nDexamethasone: PO or IV\n\nFilgrastim: Given SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IT or IV\n\nPegfilgrastim: Given SC\n\nRituximab: Given IV\n\nVincristine Sulfate: Given IV', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Concentration Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Night Sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Edema Legs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infusion Related Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neutopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Decreased White Blood Count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cytokine Release Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Ventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Steroid Myopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Event Free Survival (EFS) Where Events Defined as no Response, Loss of Response, or Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Blinatumomab, Combination Chemotherapy)', 'description': 'See detailed description.\n\nBlinatumomab: Given IV\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IT or IV\n\nDexamethasone: PO or IV\n\nFilgrastim: Given SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IT or IV\n\nPegfilgrastim: Given SC\n\nRituximab: Given IV\n\nVincristine Sulfate: Given IV'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '34.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from the first day of treatment assessed up to 3 years, 1 month', 'description': 'Time from date of treatment start until the date of first objective documentation of disease-relapse. Relapse and resistant disease will be defined based on morphological assessment of bone marrow and peripheral blood.\n\nComplete Remission (CR): Normalization of the peripheral blood and bone marrow with 5% or less blasts in normocellular or hypercellular marrow with a granulocyte count of 1 x 10\\^9/L or above, and platelet count of 100 x 10\\^9/L. Complete resolution of all sites of extramedullary disease is required for CR.\n\nComplete remission without recovery of counts (CRi): Peripheral blood and marrow results as for CR, but with incomplete recover of counts (platelets \\< 100 x 10\\^9/L; neutrophils \\< 1 x 10\\^9/L).\n\nPartial Response (PR): As above for CR except for the presence of 6-25% marrow blasts.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Negative for Minimal Residual Disease (MRD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Blinatumomab, Combination Chemotherapy)', 'description': 'See detailed description.\n\nBlinatumomab: Given IV\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IT or IV\n\nDexamethasone: PO or IV\n\nFilgrastim: Given SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IT or IV\n\nPegfilgrastim: Given SC\n\nRituximab: Given IV\n\nVincristine Sulfate: Given IV'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3 years', 'description': 'Minimal Residual Disease (MRD) was assessed by flow cytometry. MRD negativity: Absence of detectable leukemia using multiparameter flow cytometry with a sensitivity of \\</= 0.01%.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Blinatumomab, Combination Chemotherapy)', 'description': 'See detailed description.\n\nBlinatumomab: Given IV\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IT or IV\n\nDexamethasone: PO or IV\n\nFilgrastim: Given SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IT or IV\n\nPegfilgrastim: Given SC\n\nRituximab: Given IV\n\nVincristine Sulfate: Given IV'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '34.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from the first day of treatment assessed up to 3 years, 1 month', 'description': 'Response date to loss of response or last follow up. Complete Remission (CR): Normalization of the peripheral blood and bone marrow with 5% or less blasts in normocellular or hypercellular marrow with a granulocyte count of 1 x 10\\^9/L or above, and platelet count of 100 x 10\\^9/L. Complete resolution of all sites of extramedullary disease is required for CR.\n\nComplete remission without recovery of counts (CRi): Peripheral blood and marrow results as for CR, but with incomplete recover of counts (platelets \\< 100 x 10\\^9/L; neutrophils \\< 1 x 10\\^9/L).\n\nPartial Response (PR): As above for CR except for the presence of 6-25% marrow blasts.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Participants With a Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Blinatumomab, Combination Chemotherapy)', 'description': 'See detailed description.\n\nBlinatumomab: Given IV\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IT or IV\n\nDexamethasone: PO or IV\n\nFilgrastim: Given SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IT or IV\n\nPegfilgrastim: Given SC\n\nRituximab: Given IV\n\nVincristine Sulfate: Given IV'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3 years', 'description': 'defined as the percentage of patients achieving complete response (CR) or CR with inadequate count recovery (CRi). Complete Remission (CR): Normalization of the peripheral blood and bone marrow with 5% or less blasts in normocellular or hypercellular marrow with a granulocyte count of 1 x 10\\^9/L or above, and platelet count of 100 x 10\\^9/L. Complete resolution of all sites of extramedullary disease is required for CR.\n\nComplete remission without recovery of counts (CRi): Peripheral blood and marrow results as for CR, but with incomplete recover of counts (platelets \\< 100 x 10\\^9/L; neutrophils \\< 1 x 10\\^9/L).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Blinatumomab, Combination Chemotherapy)', 'description': 'See detailed description.\n\nBlinatumomab: Given IV\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IT or IV\n\nDexamethasone: PO or IV\n\nFilgrastim: Given SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IT or IV\n\nPegfilgrastim: Given SC\n\nRituximab: Given IV\n\nVincristine Sulfate: Given IV'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '37'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from the first day of treatment assessed up to 3 years, 1 month', 'description': 'Time from date of treatment start until date of death due to any cause or last Follow-up.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment (Blinatumomab, Combination Chemotherapy)', 'description': 'See detailed description.\n\nBlinatumomab: Given IV\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IT or IV\n\nDexamethasone: PO or IV\n\nFilgrastim: Given SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IT or IV\n\nPegfilgrastim: Given SC\n\nRituximab: Given IV\n\nVincristine Sulfate: Given IV'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment Period: April 2018 to May 2021'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment (Blinatumomab, Combination Chemotherapy)', 'description': 'See detailed description.\n\nBlinatumomab: Given IV\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IT or IV\n\nDexamethasone: PO or IV\n\nFilgrastim: Given SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IT or IV\n\nPegfilgrastim: Given SC\n\nRituximab: Given IV\n\nVincristine Sulfate: Given IV'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000', 'lowerLimit': '33', 'upperLimit': '66'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-06', 'size': 434012, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-29T13:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Due to Competing Studies', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-03', 'studyFirstSubmitDate': '2018-04-25', 'resultsFirstSubmitDate': '2022-05-17', 'studyFirstSubmitQcDate': '2018-04-25', 'lastUpdatePostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-03', 'studyFirstPostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event Free Survival (EFS) Where Events Defined as no Response, Loss of Response, or Death', 'timeFrame': 'Time from the first day of treatment assessed up to 3 years, 1 month', 'description': 'Time from date of treatment start until the date of first objective documentation of disease-relapse. Relapse and resistant disease will be defined based on morphological assessment of bone marrow and peripheral blood.\n\nComplete Remission (CR): Normalization of the peripheral blood and bone marrow with 5% or less blasts in normocellular or hypercellular marrow with a granulocyte count of 1 x 10\\^9/L or above, and platelet count of 100 x 10\\^9/L. Complete resolution of all sites of extramedullary disease is required for CR.\n\nComplete remission without recovery of counts (CRi): Peripheral blood and marrow results as for CR, but with incomplete recover of counts (platelets \\< 100 x 10\\^9/L; neutrophils \\< 1 x 10\\^9/L).\n\nPartial Response (PR): As above for CR except for the presence of 6-25% marrow blasts.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Negative for Minimal Residual Disease (MRD)', 'timeFrame': 'Up to 3 years', 'description': 'Minimal Residual Disease (MRD) was assessed by flow cytometry. MRD negativity: Absence of detectable leukemia using multiparameter flow cytometry with a sensitivity of \\</= 0.01%.'}, {'measure': 'Duration of Response', 'timeFrame': 'Time from the first day of treatment assessed up to 3 years, 1 month', 'description': 'Response date to loss of response or last follow up. Complete Remission (CR): Normalization of the peripheral blood and bone marrow with 5% or less blasts in normocellular or hypercellular marrow with a granulocyte count of 1 x 10\\^9/L or above, and platelet count of 100 x 10\\^9/L. Complete resolution of all sites of extramedullary disease is required for CR.\n\nComplete remission without recovery of counts (CRi): Peripheral blood and marrow results as for CR, but with incomplete recover of counts (platelets \\< 100 x 10\\^9/L; neutrophils \\< 1 x 10\\^9/L).\n\nPartial Response (PR): As above for CR except for the presence of 6-25% marrow blasts.'}, {'measure': 'Participants With a Response', 'timeFrame': 'Up to 3 years', 'description': 'defined as the percentage of patients achieving complete response (CR) or CR with inadequate count recovery (CRi). Complete Remission (CR): Normalization of the peripheral blood and bone marrow with 5% or less blasts in normocellular or hypercellular marrow with a granulocyte count of 1 x 10\\^9/L or above, and platelet count of 100 x 10\\^9/L. Complete resolution of all sites of extramedullary disease is required for CR.\n\nComplete remission without recovery of counts (CRi): Peripheral blood and marrow results as for CR, but with incomplete recover of counts (platelets \\< 100 x 10\\^9/L; neutrophils \\< 1 x 10\\^9/L).'}, {'measure': 'Overall Survival', 'timeFrame': 'Time from the first day of treatment assessed up to 3 years, 1 month', 'description': 'Time from date of treatment start until date of death due to any cause or last Follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Philadelphia Chromosome Negative', 'Recurrent B Acute Lymphoblastic Leukemia', 'Refractory B Acute Lymphoblastic Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': "This phase II trial studies how well low-intensity chemotherapy and blinatumomab work in treating patients with Philadelphia chromosome negative acute lymphoblastic leukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as dexamethasone, filgrastim, pegfilgrastim, cyclophosphamide, methotrexate, cytarabine and vincristine sulfate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving low-intensity chemotherapy and blinatumomab may work better at treating acute lymphoblastic leukemia.", 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To evaluate the combined effect of blinatumomab and mini-hyper-CVD (low-intensity chemotherapy) on event-free survival.\n\nSECONDARY OBJECTIVES:\n\nI. Evaluating other clinical efficacy endpoints (minimal residual disease \\[MRD\\] negativity, duration of response, the overall response rate \\[complete response (CR) + CR with inadequate count recovery (CRi)\\]) of the regimen occurred any time during the treatment.\n\nII. Overall survival. III. Determining the safety of the combination regimen.\n\nOUTLINE:\n\nINDUCTION PHASE: Patients receive blinatumomab intravenously (IV) continuously on days 1-28 and dexamethasone orally (PO) or IV over 30 minutes on days -3 to day 0 and 7-10. Patients also receive filgrastim subcutaneously (SC) on days 1-42 or pegfilgrastim SC on days 1 and 25, cyclophosphamide IV over 3 hours twice daily (BID) on days -3 to -1, methotrexate intrathecally (IT) on day 2 and IV over 24 hours on day 22, cytarabine IT on day 7 and IV over 3 hours BID on days 23 and 24, and vincristine sulfate IV over 15 minutes on days 0 and 7. At the discretion of the treating physician, patients may receive rituximab IV over 4-6 hours on days -3, 0, 22 and 29, and leucovorin calcium IV over 15 minutes or PO 4 times daily (QID) for 8 doses.\n\nCONSOLIDATION PHASE: Patients receive blinatumomab IV continuously on days 1-28 and dexamethasone PO or IV over 30 minutes on days 1-4 and 11-14. Patients also receive cyclophosphamide IV over 3 hours BID on days 1-3, vincristine sulfate IV over 15 minutes on days 1 and 11, filgrastim SC on days 1-4 and 22-42 or pegfilgrastim SC on day 5 and 25, methotrexate IT on day 2 and IV over 24 hours on day 22, cytarabine IT on day 7 and IV over 3 hours BID on days 23 and 24. At the discretion of the treating physician, patients may receive rituximab IV over 4-6 hours on days 1, 8, 22 and 29, and leucovorin calcium IV over 15 minutes or PO QID for 8 doses. Treatment repeats every 42 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.\n\nMAINTENANCE PHASE: Patients receive prednisone PO and vincristine sulfate IV over 15 minutes on days 1-5 of cycles 5-9, 7-11 and 13-24, and mercaptopurine PO BID on days 1-28 of cycles 1-5, 7-11, and 13-24. Patients also receive methotrexate PO once a week and blinatumomab IV continuously on days 1-28 of cycles 6 and 12. Cycles repeat every 28 days for up to 24 cycles (2 years) in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up at 30 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with first or second relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)\n* Performance status =\\< 3 (Eastern Cooperative Oncology Group \\[ECOG\\] scale)\n* Total serum bilirubin =\\< 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the principal investigator (PI)\n* Alanine aminotransferase (ALT) =\\< 3 x ULN, unless due to the underlying leukemia approved by the PI\n* Aspartate aminotransferase (AST) =\\< 3 x ULN unless due to the underlying leukemia approved by the PI\n* Signed informed consent\n* Women of childbearing potential (WOCBP) or male subjects with a partner who is WOCBP must agree to use contraception during the study, if sexually active\n\nExclusion Criteria:\n\n* Patients with Philadelphia chromosome (Ph)-positive ALL or Burkitt leukemia\n* Active, uncontrolled central nervous system (CNS) leukemia involvement\n* Active serious infection not controlled by oral or intravenous antibiotics\n* Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year\n* Known hepatitis B or C infection, or known seropositivity for human immunodeficiency virus (HIV)\n* Active grade III-V cardiac failure as defined by the New York Heart Association criteria\n* Patients with a cardiac ejection fraction (as measured by either multi-gated acquisition \\[MUGA\\] or echocardiogram) \\< 40%\n* Prior history of treatment with blinatumomab\n* Treatment with any investigational antileukemic agents or chemotherapy agents in the last two weeks, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator\n* Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception; women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months; in addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control"}, 'identificationModule': {'nctId': 'NCT03518112', 'briefTitle': 'Low-Intensity Chemotherapy and Blinatumomab in Treating Patients With Philadelphia Chromosome Negative Relapsed or Refractory Acute Lymphoblastic Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Phase II Study of the Combination of Low-Intensity Chemotherapy and Blinatumomab in Patients With Philadelphia Chromosome Negative Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL)', 'orgStudyIdInfo': {'id': '2017-0127'}, 'secondaryIdInfos': [{'id': 'NCI-2018-00737', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2017-0127', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (blinatumomab, combination chemotherapy)', 'description': 'See detailed description.', 'interventionNames': ['Biological: Blinatumomab', 'Drug: Cyclophosphamide', 'Drug: Cytarabine', 'Drug: Dexamethasone', 'Biological: Filgrastim', 'Other: Laboratory Biomarker Analysis', 'Drug: Leucovorin Calcium', 'Drug: Mercaptopurine', 'Drug: Methotrexate', 'Biological: Pegfilgrastim', 'Biological: Rituximab', 'Drug: Vincristine Sulfate']}], 'interventions': [{'name': 'Blinatumomab', 'type': 'BIOLOGICAL', 'otherNames': ['Anti-CD19 x Anti-CD3 Bispecific Monoclonal Antibody', 'Anti-CD19/Anti-CD3 Recombinant Bispecific Monoclonal Antibody MT103', 'Blincyto', 'MEDI-538', 'MT-103'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (blinatumomab, combination chemotherapy)']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['(-)-Cyclophosphamide', '2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate', 'Carloxan', 'Ciclofosfamida', 'Ciclofosfamide', 'Cicloxal', 'Clafen', 'Claphene', 'CP monohydrate', 'CTX', 'CYCLO-cell', 'Cycloblastin', 'Cycloblastine', 'Cyclophospham', 'Cyclophosphamid monohydrate', 'Cyclophosphamide Monohydrate', 'Cyclophosphamidum', 'Cyclophosphan', 'Cyclophosphane', 'Cyclophosphanum', 'Cyclostin', 'Cyclostine', 'Cytophosphan', 'Cytophosphane', 'Cytoxan', 'Fosfaseron', 'Genoxal', 'Genuxal', 'Ledoxina', 'Mitoxan', 'Neosar', 'Revimmune', 'Syklofosfamid', 'WR- 138719'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (blinatumomab, combination chemotherapy)']}, {'name': 'Cytarabine', 'type': 'DRUG', 'otherNames': ['.beta.-Cytosine arabinoside', '1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone', '1-.beta.-D-Arabinofuranosylcytosine', '1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone', '1-Beta-D-arabinofuranosylcytosine', '1.beta.-D-Arabinofuranosylcytosine', '2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-', '2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-', 'Alexan', 'Ara-C', 'ARA-cell', 'Arabine', 'Arabinofuranosylcytosine', 'Arabinosylcytosine', 'Aracytidine', 'Aracytin', 'Aracytine', 'Beta-cytosine Arabinoside', 'CHX-3311', 'Cytarabinum', 'Cytarbel', 'Cytosar', 'Cytosine Arabinoside', 'Cytosine-.beta.-arabinoside', 'Cytosine-beta-arabinoside', 'Erpalfa', 'Starasid', 'Tarabine PFS', 'U 19920', 'U-19920', 'Udicil', 'WR-28453'], 'description': 'Given IT or IV', 'armGroupLabels': ['Treatment (blinatumomab, combination chemotherapy)']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Aacidexam', 'Adexone', 'Aknichthol Dexa', 'Alba-Dex', 'Alin', 'Alin Depot', 'Alin Oftalmico', 'Amplidermis', 'Anemul mono', 'Auricularum', 'Auxiloson', 'Baycadron', 'Baycuten', 'Baycuten N', 'Cortidexason', 'Cortisumman', 'Decacort', 'Decadrol', 'Decadron', 'Decadron DP', 'Decalix', 'Decameth', 'Decasone R.p.', 'Dectancyl', 'Dekacort', 'Deltafluorene', 'Deronil', 'Desamethasone', 'Desameton', 'Dexa-Mamallet', 'Dexa-Rhinosan', 'Dexa-Scheroson', 'Dexa-sine', 'Dexacortal', 'Dexacortin', 'Dexafarma', 'Dexafluorene', 'Dexalocal', 'Dexamecortin', 'Dexameth', 'Dexamethasone Intensol', 'Dexamethasonum', 'Dexamonozon', 'Dexapos', 'Dexinoral', 'Dexone', 'Dinormon', 'Fluorodelta', 'Fortecortin', 'Gammacorten', 'Hexadecadrol', 'Hexadrol', 'Lokalison-F', 'Loverine', 'Methylfluorprednisolone', 'Millicorten', 'Mymethasone', 'Orgadrone', 'Spersadex', 'TaperDex', 'Visumetazone', 'ZoDex'], 'description': 'PO or IV', 'armGroupLabels': ['Treatment (blinatumomab, combination chemotherapy)']}, {'name': 'Filgrastim', 'type': 'BIOLOGICAL', 'otherNames': ['G-CSF', 'Neupogen', 'r-metHuG-CSF', 'Recombinant Methionyl Human Granulocyte Colony Stimulating Factor', 'rG-CSF', 'Tevagrastim'], 'description': 'Given SC', 'armGroupLabels': ['Treatment (blinatumomab, combination chemotherapy)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (blinatumomab, combination chemotherapy)']}, {'name': 'Leucovorin Calcium', 'type': 'DRUG', 'otherNames': ['Adinepar', 'Calcifolin', 'Calcium (6S)-Folinate', 'Calcium Folinate', 'Calcium Leucovorin', 'Calfolex', 'Calinat', 'Cehafolin', 'Citofolin', 'Citrec', 'citrovorum factor', 'Cromatonbic Folinico', 'Dalisol', 'Disintox', 'Divical', 'Ecofol', 'Emovis', 'Factor, Citrovorum', 'Flynoken A', 'Folaren', 'Folaxin', 'FOLI-cell', 'Foliben', 'Folidan', 'Folidar', 'Folinac', 'Folinate Calcium', 'folinic acid', 'Folinic Acid Calcium Salt Pentahydrate', 'Folinoral', 'Folinvit', 'Foliplus', 'Folix', 'Imo', 'Lederfolat', 'Lederfolin', 'Leucosar', 'leucovorin', 'Rescufolin', 'Rescuvolin', 'Tonofolin', 'Wellcovorin'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (blinatumomab, combination chemotherapy)']}, {'name': 'Mercaptopurine', 'type': 'DRUG', 'otherNames': ['3H-Purine-6-thiol', '6 MP', '6 Thiohypoxanthine', '6 Thiopurine', '6-Mercaptopurine', '6-Mercaptopurine Monohydrate', '6-MP', '6-Purinethiol', '6-Thiopurine', '6-Thioxopurine', '6H-Purine-6-thione, 1,7-dihydro- (9CI)', '7-Mercapto-1,3,4,6-tetrazaindene', 'Alti-Mercaptopurine', 'Azathiopurine', 'BW 57-323H', 'Flocofil', 'Ismipur', 'Leukerin', 'Leupurin', 'Mercaleukim', 'Mercaleukin', 'Mercaptina', 'Mercaptopurinum', 'Mercapurin', 'Mern', 'NCI-C04886', 'Puri-Nethol', 'Purimethol', 'Purine, 6-mercapto-', 'Purine-6-thiol (8CI)', 'Purine-6-thiol, monohydrate', 'Purinethiol', 'Purinethol', 'U-4748', 'WR-2785'], 'description': 'Given PO', 'armGroupLabels': ['Treatment (blinatumomab, combination chemotherapy)']}, {'name': 'Methotrexate', 'type': 'DRUG', 'otherNames': ['Abitrexate', 'Alpha-Methopterin', 'Amethopterin', 'Brimexate', 'CL 14377', 'CL-14377', 'Emtexate', 'Emthexat', 'Emthexate', 'Farmitrexat', 'Fauldexato', 'Folex', 'Folex PFS', 'Lantarel', 'Ledertrexate', 'Lumexon', 'Maxtrex', 'Medsatrexate', 'Metex', 'Methoblastin', 'Methotrexate LPF', 'Methotrexate Methylaminopterin', 'Methotrexatum', 'Metotrexato', 'Metrotex', 'Mexate', 'Mexate-AQ', 'MTX', 'Novatrex', 'Rheumatrex', 'Texate', 'Tremetex', 'Trexeron', 'Trixilem', 'WR-19039'], 'description': 'Given IT or IV', 'armGroupLabels': ['Treatment (blinatumomab, combination chemotherapy)']}, {'name': 'Pegfilgrastim', 'type': 'BIOLOGICAL', 'otherNames': ['Filgrastim SD-01', 'filgrastim-SD/01', 'Fulphila', 'HSP-130', 'Jinyouli', 'Neulasta', 'Neulastim', 'Pegfilgrastim Biosimilar HSP-130', 'Pegfilgrastim Biosimilar Pegcyte', 'Pegfilgrastim-jmdb', 'SD-01', 'SD-01 sustained duration G-CSF'], 'description': 'Given SC', 'armGroupLabels': ['Treatment (blinatumomab, combination chemotherapy)']}, {'name': 'Rituximab', 'type': 'BIOLOGICAL', 'otherNames': ['ABP 798', 'BI 695500', 'C2B8 Monoclonal Antibody', 'Chimeric Anti-CD20 Antibody', 'CT-P10', 'IDEC-102', 'IDEC-C2B8', 'IDEC-C2B8 Monoclonal Antibody', 'MabThera', 'Monoclonal Antibody IDEC-C2B8', 'PF-05280586', 'Rituxan', 'Rituximab ABBS', 'Rituximab Biosimilar ABP 798', 'Rituximab Biosimilar BI 695500', 'Rituximab Biosimilar CT-P10', 'Rituximab Biosimilar GB241', 'Rituximab Biosimilar IBI301', 'Rituximab Biosimilar JHL1101', 'Rituximab Biosimilar PF-05280586', 'Rituximab Biosimilar RTXM83', 'Rituximab Biosimilar SAIT101', 'rituximab biosimilar TQB2303', 'rituximab-abbs', 'RTXM83', 'Truxima'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (blinatumomab, combination chemotherapy)']}, {'name': 'Vincristine Sulfate', 'type': 'DRUG', 'otherNames': ['Kyocristine', 'Leurocristine sulfate', 'Leurocristine, sulfate', 'Oncovin', 'Vincasar', 'Vincosid', 'Vincrex', 'Vincristine, sulfate'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (blinatumomab, combination chemotherapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Elias Jabbour', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}