Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT06257394
Status:
RECRUITING
Last Update Posted:
2025-06-08
First Post:
2024-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2034-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2024-02-01', 'studyFirstSubmitQcDate': '2024-02-12', 'lastUpdatePostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2034-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event free survival', 'timeFrame': 'Up to 5 years'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Up to 5 years', 'description': 'The time until defined by date of all-cause mortality from the date of 1st infusion'}, {'measure': 'Recurred rate', 'timeFrame': 'Up to 5 years', 'description': 'As the period from enrollment to disease progression/recurrence'}, {'measure': 'Death rate related to infusion', 'timeFrame': 'Up to 5 years', 'description': 'The time until defined by date of drug-related mortality from the date of 1st infusion'}, {'measure': 'Adverse Event', 'timeFrame': 'From Day 1 of the clinical trial to 28 days after last drug administration'}, {'measure': 'The rate of Hematopoietic stem cell transplantation', 'timeFrame': 'Up to 5 years', 'description': 'The rate of Hematopoietic stem cell transplantation after the Induction and consolidation therapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['VHR ALL', 'NGS-MRD'], 'conditions': ['Acute Lymphoblastic Leukemia, Pediatric']}, 'descriptionModule': {'briefSummary': 'Very high-risk acute lymphoblastic leukemia', 'detailedDescription': '* Arm A : Philadelphia chromosome-positive : Induction (Except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.)\n\n * Morphologic Complete Remission after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3\n\n 1. If Minimal Residual Disease \\& qPCR not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, High Dose Cytarabine → DI(Delayed Intensification) #1 → IM(Interim Maintenance) #2 → DI(Delayed Intensification) #2 → Maintenance\n 2. If Minimal Residual Disease or qPCR(Quantitative Polymerase Chain Reaction) positivie after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)\n * M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)\n\n 1. If Minimal Residual Disease \\& qPCR(Quantitative Polymerase Chain Reaction) not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, HD Cytarabine\n 2. If Minimal Residual Disease or qPCR(Quantitative Polymerase Chain Reaction) positivie after the post-reinduction : Consolidation #3 using Blinatumomab\n\n * In Arm A, except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.\n* Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction\n\n * Morphologic Complete Remission after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3\n\n 1. If Minimal Residual Disease not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, High Dose Cytarabine → Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)\n 2. If Minimal Residual Disease positivie after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)\n * M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)\n\n 1. If Minimal Residual Disease not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, High Dose Cytarabine\n 2. If Minimal Residual Disease positivie after the post-reinduction : Consolidation #3 using Blinatumomab'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients diagnosed with ALL between the ages of 1 and 19 years at the time of diagnosis who meet one or more of the following conditions:\n\n * Philadelphia chromosome-positive t(9;22)(q34;q11) or\n * Patients with failed remission who had blast \\> 5% on bone marrow test after initial remission induction therapy or\n * Hypodiploidy (Number of chromosomes \\< 44 (less than 44)) or\n * E2A-HLF(Hepatic Leukemia Factor) translocation-positive or\n * When the prognosis is judged to be poor according to NGS-MRD results among high-risk ALL patients (i) In B-ALL, the NGS-MRD(Next Generation Sequencing-Minimal Residual Disease) after consolidation therapy is 0.01% or more, and the NGS-MRD followed during interim maintenance treatment is also 0.01% or more, (ii) In T-ALL, NGS-MRD(Next Generation Sequencing-Minimal Residual Disease) is more than 0.01% after consolidation therapy\n\nExclusion Criteria:\n\n* Participants with contraindications to medications\n* When the study participant or their legal representative withdraws consent\n* Pregnant or lactating women (patients of child-bearing potential require adequate contraception during the study period)\n* Participants who are medically unsuitable to participate in this study at the discretion of the investigator Participants participating in other interventional studies other than this protocol'}, 'identificationModule': {'nctId': 'NCT06257394', 'acronym': 'VHR ALL', 'briefTitle': 'Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Multi-center Clinical Trial for Optimal Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea', 'orgStudyIdInfo': {'id': 'H-2401-028-1500'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[Arm A, Dasatinib(Sprycel) Arm]', 'description': '▪ Arm A : Philadelphia chromosome-positive : Induction (Except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.)\n\n* Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3\n\n 1. If MRD \\& qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → DI #1 → IM #2 → DI #2 → Maintenance\n 2. If MRD or qPCR positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT\n* M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT\n\n 1. If MRD \\& qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine\n 2. If MRD or qPCR positive after the post-reinduction : Consolidation #3 using Blinatumomab\n\n * In Arm A, except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.', 'interventionNames': ['Drug: Dasatinib(Sprycel) arm']}, {'type': 'EXPERIMENTAL', 'label': '[Arm B, Non-Dasatinib(Sprycel) Arm]', 'description': '▪ Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction\n\n* Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3\n\n 1. If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → Allogeneic HSCT\n 2. If MRD positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT\n* M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT\n\n 1. If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine\n 2. If MRD positive after the post-reinduction : Consolidation #3 using Blinatumomab', 'interventionNames': ['Drug: Non-Dasatinib(Sprycel) arm']}], 'interventions': [{'name': 'Dasatinib(Sprycel) arm', 'type': 'DRUG', 'description': '▪ Arm A : Philadelphia chromosome-positive : Induction (Except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.)\n\n* Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3\n\n 1. If MRD \\& qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → DI #1 → IM #2 → DI #2 → Maintenance\n 2. If MRD or qPCR positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT\n* M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT\n\n 1. If MRD \\& qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine\n 2. If MRD or qPCR positive after the post-reinduction : Consolidation #3 using Blinatumomab\n\n * In Arm A, except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.', 'armGroupLabels': ['[Arm A, Dasatinib(Sprycel) Arm]']}, {'name': 'Non-Dasatinib(Sprycel) arm', 'type': 'DRUG', 'description': '▪ Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction\n\n* Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3\n\n 1. If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → Allogeneic HSCT\n 2. If MRD positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT\n* M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3‡ → Allogeneic HSCT\n\n 1. If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine\n 2. If MRD positive after the post-reinduction : Consolidation #3 using Blinatumomab', 'armGroupLabels': ['[Arm B, Non-Dasatinib(Sprycel) Arm]']}]}, 'contactsLocationsModule': {'locations': [{'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': '05505', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ho Joon Im, Professor', 'role': 'CONTACT', 'email': 'hojim@amc.seoul.kr', 'phone': '8201062311573'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hee Young Ju, Professor', 'role': 'CONTACT', 'email': 'hyju320@gmail.com', 'phone': '+82-2-3410-0865'}], 'facility': 'Samsung Medical Center', '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}}, {'zip': '50612', 'city': 'Yangsan', 'status': 'NOT_YET_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}}], 'centralContacts': [{'name': 'Hyoung Jin Kang, Ph.D', 'role': 'CONTACT', 'email': 'kanghj@snu.ac.kr', 'phone': '+82-2-2072-3452'}, {'name': 'Hyoung Jin Kang', 'role': 'CONTACT', 'email': 'kanghj@snu.ac.kr', 'phone': '+82220723452'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hyoung Jin Kang', 'class': 'OTHER'}, 'collaborators': [{'name': 'Asan Medical Center', 'class': 'OTHER'}, {'name': 'Samsung Medical Center', 'class': 'OTHER'}, {'name': 'Severance Hospital', 'class': 'OTHER'}, {'name': 'Pusan National University Yangsan Hospital', 'class': 'OTHER'}, {'name': "Seoul St. Mary's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hyoung Jin Kang', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}