Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT04440267
Status:
RECRUITING
Last Update Posted:
2025-08-06
First Post:
2020-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015456', 'term': 'Leukemia, Biphenotypic, Acute'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D001215', 'term': 'Asparaginase'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D000092004', 'term': 'Tyrosine Kinase Inhibitors'}], 'ancestors': [{'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'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': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D000581', 'term': 'Amidohydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D013438', 'term': 'Sulfhydryl Compounds'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D047428', 'term': 'Protein Kinase Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2020-06-11', 'studyFirstSubmitQcDate': '2020-06-17', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Chromosomal abnormalities detected by G-banding', 'timeFrame': 'Baseline'}, {'measure': 'Fusion genes detected by polymerase chain reaction', 'timeFrame': 'Baseline'}, {'measure': 'Mutations detected by next-generation sequencing', 'timeFrame': 'Baseline'}, {'measure': 'Minimal residual disease（MRD）', 'timeFrame': '1 year', 'description': 'The presence of small numbers of leukemic cells detected by the flow cytometry after remission'}], 'primaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'up to 5 years', 'description': 'From the date of diagnosis until the date of death from any cause,'}], 'secondaryOutcomes': [{'measure': 'Relapse free survival (RFS)', 'timeFrame': 'up to 5 years', 'description': 'From the date of CR until the date of relapse or death'}, {'measure': 'The complete remission (CR) rate', 'timeFrame': 'up to 2.5 years', 'description': 'Incidence of complete remission after induction chemotherapy'}, {'measure': 'Mortality within 60 days', 'timeFrame': 'up to 60 days', 'description': 'Proportion of patients died within 60 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Leukemia of Ambiguous Lineage']}, 'descriptionModule': {'briefSummary': 'In this prospective, single arm, open label, clinical trial, a total of 50 acute leukemia of ambiguous lineage patients will be enrolled. Patients will receive acute lymphoblastic leukemia (ALL) -based chemotherapy and are permitted to receive allogeneic hematopoietic stem cell transplantation (HSCT) after CR . Otherwise, they will finish the consolidation chemotherapy. Patients with t(9;22) will receive chemotherapy combined with tyrosine kinase inhibitors. The purpose of current study is to evaluate the clinical efficacy of ALL-based chemotherapy，effect of genetic abnormality and minimal residual disease (MRD) on prognosis in patients with acute leukemia of ambiguous lineage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged above 14 years with acute leukemia of ambiguous lineage .\n2. Eastern Cooperative Oncology Group (ECOG) Performance status 2.\n3. Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); serum glutamic-oxaloacetic transaminase(SGOT) and serum glutamic pyruvic transaminase(SGPT) ≤ 2.5 x ULN; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; Patients must have adequate cardiac function (ejection fraction ≥ 45 % on Multiple Gated Acquisition (MUGA) scan).\n4. Patients must have the following laboratory values (≥ lower limit of normal (LLN) or corrected to within normal limits with supplements prior to the first dose of study medication.): Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN\n5. Patients should sign informed consent form.\n\nExclusion Criteria:\n\n1. Impaired cardiac function:\n\n Long QT syndrome or a known family history of long QT syndrome; clinically significant resting brachycardia (\\<50 beats per minute); ejection fraction \\< 45 % on MUGA scan. Corrected QT (QTc) interval \\> 450 msec on baseline ECG (using the QTcF formula). If QTcF interval\\>450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc. Myocardial infarction within 12 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias).\n2. Other concurrent severe and/or uncontrolled medical conditions:\n\n Patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease.\n3. Patients who are: (a) pregnant and (b) breast feeding.'}, 'identificationModule': {'nctId': 'NCT04440267', 'briefTitle': 'Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Hematology & Blood Diseases Hospital, China'}, 'officialTitle': 'A Prospective, Single Arm, Open Label, Clinical Trial to Evaluate the Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage', 'orgStudyIdInfo': {'id': 'IIT2020009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'single arm', 'description': 'Patients will receive acute lymphoblastic leukemia (ALL) -based chemotherapy and are permitted to receive allogeneic hematopoietic stem cell transplantation (HSCT) in CR. Otherwise, they will finish the consolidation chemotherapy. Patients with t(9;22) will receive chemotherapy combined with tyrosine kinase inhibitors.', 'interventionNames': ['Drug: vincristine', 'Drug: daunorubicin', 'Drug: cyclophosphamide', 'Drug: L-Asparaginase', 'Drug: prednisone', 'Drug: mercaptopurine', 'Drug: methotrexate', 'Drug: dexamethasone', 'Drug: Tyrosine kinase inhibitor']}], 'interventions': [{'name': 'vincristine', 'type': 'DRUG', 'description': 'acute lymphoblastic leukemia (ALL) -based chemotherapy', 'armGroupLabels': ['single arm']}, {'name': 'daunorubicin', 'type': 'DRUG', 'description': 'acute lymphoblastic leukemia (ALL) -based chemotherapy', 'armGroupLabels': ['single arm']}, {'name': 'cyclophosphamide', 'type': 'DRUG', 'description': 'acute lymphoblastic leukemia (ALL) -based chemotherapy', 'armGroupLabels': ['single arm']}, {'name': 'L-Asparaginase', 'type': 'DRUG', 'description': 'acute lymphoblastic leukemia (ALL) -based chemotherapy', 'armGroupLabels': ['single arm']}, {'name': 'prednisone', 'type': 'DRUG', 'description': 'acute lymphoblastic leukemia (ALL) -based chemotherapy', 'armGroupLabels': ['single arm']}, {'name': 'mercaptopurine', 'type': 'DRUG', 'description': 'acute lymphoblastic leukemia (ALL) -based chemotherapy', 'armGroupLabels': ['single arm']}, {'name': 'methotrexate', 'type': 'DRUG', 'description': 'acute lymphoblastic leukemia (ALL) -based chemotherapy', 'armGroupLabels': ['single arm']}, {'name': 'dexamethasone', 'type': 'DRUG', 'description': 'acute lymphoblastic leukemia (ALL) -based chemotherapy', 'armGroupLabels': ['single arm']}, {'name': 'Tyrosine kinase inhibitor', 'type': 'DRUG', 'description': 'acute lymphoblastic leukemia (ALL) -based chemotherapy', 'armGroupLabels': ['single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300020', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hui Wei', 'role': 'CONTACT'}], 'facility': 'HBDH', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Jianxiang Wang, Dr', 'role': 'CONTACT', 'email': 'wangjx@ihcams.ac.cn', 'phone': '86-22-23909120'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Hematology & Blood Diseases Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}