Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-27 @ 4:49 AM
Study NCT ID:
NCT06099366
Status:
RECRUITING
Last Update Posted:
2025-06-08
First Post:
2023-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001215', 'term': 'Asparaginase'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'D004317', 'term': 'Doxorubicin'}], 'ancestors': [{'id': 'D000581', 'term': 'Amidohydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'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': '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': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013438', 'term': 'Sulfhydryl Compounds'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'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': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2033-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2023-10-18', 'studyFirstSubmitQcDate': '2023-10-24', 'lastUpdatePostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2033-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '5-year event free survival rate', 'timeFrame': 'Up to 5-years'}], 'secondaryOutcomes': [{'measure': 'Confirmation of the therapeutic effect of the initial treatment response', 'timeFrame': 'Up to 5-years', 'description': 'Relapse-free survival between two groups(NGS-MRD positive vs. NGS MRD negative after induction) offsets by NGS MRD based stratified treatment'}, {'measure': 'Disease prognosis-related factor', 'timeFrame': 'Up to 5-years', 'description': 'Relapse-free survival according to presence or absence of known good prognosis factors(high hyperdilpoidy, ETV6/RUNX1, Trisomy 4/10/17) have no clinical significance when NGS MRD based stratified treatment is performed.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Standard Risk ALL', 'NGS MRD'], 'conditions': ['Lymphoblastic Leukemia in Children']}, 'descriptionModule': {'briefSummary': 'Aim of this study is to investigate the outcome of NGS MRD based risk stratified treatment for high risk acute lymphoblastic leukemia in children and adolescents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': '\\<Inclusion Criteria\\>\n\n* Newly diagnosed pediatric/adolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-4 of following\n\n 1. 1 year old ≤ Age \\< 10 years old\n 2. white blood cell at initial diagnosis \\< 5x10\\^10/L (50,000uL)\n 3. No testis involvement\n 4. Satisfaction of following organ functions\n\nA. Kidney function (satisfies i or ii) i. Creatinine clearance (or radioisotope-measured GFR) ≥ 70mL/min/1.73m2 ii. Creatinine value according to age/sec satisfies the following:\n\n1 to \\< 2 years: Male: 0.6 / Female: 0.6, 2 to \\< 6 years: Male: 0.8 / Female: 0.8, 6 to \\< 10 years: Male: 1 / Female: 1, 10 to \\< 13 years: Male: 1.2 / Female: 1.2, 13 to \\< 16 years: Male: 1.5 / Female: 1.4, ≥ 16 years: Male: 1.7 / Female: 1.4 However, subjects who meet the selection criteria within 1 week before registration after receiving appropriate conservative treatment, including fluid therapy, can be registered.\n\nB. Liver function i. Direct bilirubin \\< 3.0mg/dL\n\n\\<Exclusion Criteria\\>\n\n1. Steroid administration within 2 weeks before the registration\n2. t(9;22) or t(4;11)(q11;q23) or chromosome \\< 44 or iAMP21 or t(17;19)/TCF3-HLF\n3. Newly diagnosed T cell ALL\n4. One of the following syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or other bone marrow failure syndrome\n5. Burkitt leukemia/lymphoma\n6. In the presence of electrocardiographic findings suggesting uncontrolled cardiac dysfunction (e.g., unstable ischemia, symptomatic arrhythmia, congestive heart failure) or congenital long QT syndrome\n7. When the clinical trial subject(or legal representative) does not consent or is unable to give written consent'}, 'identificationModule': {'nctId': 'NCT06099366', 'acronym': 'SR ALL', 'briefTitle': 'Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in', 'orgStudyIdInfo': {'id': '2023-09-142'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard-low (SL)', 'description': 'Induction-\\> SL Consolidation(4weeks)-\\> Interim Maintenance 1st-\\> Delayed Intesificaion-\\> Interim Maintenance 2nd-\\> Maintenance', 'interventionNames': ['Drug: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate', 'Drug: Consolidation: Vincristine, Mecaptopurine, Intrathecal Methotrexate', 'Drug: Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate', 'Drug: Delayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate', 'Drug: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate']}, {'type': 'EXPERIMENTAL', 'label': 'Standard-average (SA)', 'description': 'Induction-\\> SH Consolidation(4weeks)-\\> Intensified Consolidation(4weeks)-\\> Interim Maintenance 1st-\\> Delayed Intesificaion-\\> Interim Maintenance 2nd-\\> Maintenance', 'interventionNames': ['Drug: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate', 'Drug: Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate', 'Drug: Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate', 'Drug: Delayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate', 'Drug: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate']}, {'type': 'EXPERIMENTAL', 'label': 'Standard-high 1 (SH1)', 'description': 'Induction-\\> SL Consolidation(4weeks)-\\> Intesified Consolidattion(4weeks)-\\> Interim Maintenance 1st-\\> Delayed Intesificaion 1st-\\> Interim Maintenance 2nd-\\> Delayed Intestificaion 2nd-\\> Maintenance', 'interventionNames': ['Drug: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate', 'Drug: Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate', 'Drug: Interim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate', 'Drug: Delayed Intesification(DI): Vincristine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate', 'Drug: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate']}, {'type': 'EXPERIMENTAL', 'label': 'Standard-high 2 (SH2)', 'description': 'Induction-\\> SH Consolidation(4weeks)-\\> Intensified Consolidation(4weeks)-\\> Interim Maintenance 1st-\\> Delayed Intesificaion 1st-\\> Interim Maintenance 2nd-\\> Delayed Intestificaion 2nd-\\> Maintenance', 'interventionNames': ['Drug: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate', 'Drug: Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate', 'Drug: Interim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate', 'Drug: Delayed Intesification(DI): Vincristine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate', 'Drug: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate']}], 'interventions': [{'name': 'induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate', 'type': 'DRUG', 'description': 'vincristine 1.5mg/m2 L-asparaginase 6,000U/m2 Dexamethasone 6mg/m2 Intrathecal Cytarabine Intrathecal Methotreate', 'armGroupLabels': ['Standard-average (SA)', 'Standard-high 1 (SH1)', 'Standard-high 2 (SH2)', 'Standard-low (SL)']}, {'name': 'Consolidation: Vincristine, Mecaptopurine, Intrathecal Methotrexate', 'type': 'DRUG', 'description': 'Vincristine 1.5mg/m2 Mecaptopurine 50mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 L-asparaginase 6,000U/m2 Intrathecal Methotrexate', 'armGroupLabels': ['Standard-low (SL)']}, {'name': 'Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate', 'type': 'DRUG', 'description': 'Vincristine 1.5mg/m2 Mecaptopurine 50mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 L-asparaginase 6,000IU/m2 Intrathecal Methotrexate', 'armGroupLabels': ['Standard-average (SA)', 'Standard-high 1 (SH1)', 'Standard-high 2 (SH2)']}, {'name': 'Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate', 'type': 'DRUG', 'description': 'Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Intrathecal Methotrexate', 'armGroupLabels': ['Standard-average (SA)', 'Standard-low (SL)']}, {'name': 'Interim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate', 'type': 'DRUG', 'description': 'Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Mecaptopurine: 25mg/m2 Intrathecal Methotrexate', 'armGroupLabels': ['Standard-high 1 (SH1)', 'Standard-high 2 (SH2)']}, {'name': 'Delayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate', 'type': 'DRUG', 'description': 'Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 L-asparaginase 6,000IU/m2 Doxorubicin 25mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 Dexamethasone 10mg/m2 Intrathecal Methotrexate', 'armGroupLabels': ['Standard-average (SA)', 'Standard-low (SL)']}, {'name': 'Delayed Intesification(DI): Vincristine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate', 'type': 'DRUG', 'description': 'Vincristine 1.5mg/m2 L-asparaginase 6,000IU/m2 Doxorubicin 25mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 100mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate', 'armGroupLabels': ['Standard-high 1 (SH1)', 'Standard-high 2 (SH2)']}, {'name': 'Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate', 'type': 'DRUG', 'description': 'Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 Methotrexate 20mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate', 'armGroupLabels': ['Standard-average (SA)', 'Standard-high 1 (SH1)', 'Standard-high 2 (SH2)', 'Standard-low (SL)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03174', 'city': 'Seoul', 'state': 'Other (Non U.s.)', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyery KIM, MD, PhD', 'role': 'CONTACT', 'email': 'taban@hanmail.net', 'phone': '82-2-3010-3373'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03174', 'city': 'Seoul', 'state': 'Other (Non U.s.)', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hee Young Ju, MD, PhD', 'role': 'CONTACT', 'email': 'heeyoung.ju@samsung.com', 'phone': '82-2-3410-0865'}, {'name': 'hyunjung Shin', 'role': 'CONTACT', 'email': 'hjds.shin@samsung.com', 'phone': '82-2-3410-6763'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '50612', 'city': 'Yangsan', 'state': 'Yangsan-si', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Eu Jeen Yang, Professor', 'role': 'CONTACT', 'email': '41sirius@hanmail.net', 'phone': '+82-10-6478-8489'}], 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}, {'zip': '58128', 'city': 'Hwasun', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hee Jo Baek, Professor', 'role': 'CONTACT', 'email': 'swan93@naver.com', 'phone': '+82-61-379-8060'}], 'facility': 'Chonnam National University Hwasun Hospital', 'geoPoint': {'lat': 35.06125, 'lon': 126.98746}}, {'zip': '63241', 'city': 'Jeju City', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyun Sik Kang, Professor', 'role': 'CONTACT', 'email': 'medyapsb@naver.com', 'phone': '+82-64-717-1528'}], 'facility': 'Jeju National University Hospital', 'geoPoint': {'lat': 33.50972, 'lon': 126.52194}}, {'zip': '02841', 'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jun Eun Park, Professor', 'role': 'CONTACT', 'email': 'pedonco@korea.ac.kr', 'phone': '+82-10-9476-0932'}], 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03080', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyoung Jin Kang, Professor', 'role': 'CONTACT', 'email': 'kanghj@snu.ac.kr', 'phone': '+82-2-2072-3452'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung-min Hahn, Professor', 'role': 'CONTACT', 'email': 'bluenile88@yuhs.ac', 'phone': '+82-2-2258-9943'}], 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jae Won Yoo, Professor', 'role': 'CONTACT', 'email': 'hoiring0209@gmail.com', 'phone': '+82-2-2258-6763'}], 'facility': "Seoul saint Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hee Young Ju, MD, Phd', 'role': 'CONTACT', 'email': 'heeyoung.ju@samsung.com', 'phone': '82-2-3410-0865'}, {'name': 'hyunjung Shin', 'role': 'CONTACT', 'email': 'hjds.shin@samsung.com', 'phone': '82-2-3410-6763'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hee Young Ju', 'class': 'OTHER'}, 'collaborators': [{'name': 'Asan Medical Center', 'class': 'OTHER'}, {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, {'name': "Seoul St. Mary's Hospital", 'class': 'OTHER'}, {'name': 'Severance Hospital', 'class': 'OTHER'}, {'name': 'Pusan National University Yangsan Hospital', 'class': 'OTHER'}, {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}, {'name': 'Chonnam National University Hospital', 'class': 'OTHER'}, {'name': 'Jeju National University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Hee Young Ju', 'investigatorAffiliation': 'Samsung Medical Center'}}}}