Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-03-05 @ 7:53 PM
Study NCT ID:
NCT05313958
Status:
RECRUITING
Last Update Posted:
2023-07-27
First Post:
2021-12-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007948', 'term': 'Leukemia, Monocytic, Acute'}], 'ancestors': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017338', 'term': 'Cladribine'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D015255', 'term': 'Idarubicin'}, {'id': 'D008942', 'term': 'Mitoxantrone'}, {'id': 'D000077157', 'term': 'Sorafenib'}], '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': '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': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'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': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D000880', 'term': 'Anthraquinones'}, {'id': 'D000095322', 'term': 'Anthrones'}, {'id': 'D000873', 'term': 'Anthracenes'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 43}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-25', 'studyFirstSubmitDate': '2021-12-26', 'studyFirstSubmitQcDate': '2022-03-28', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '3 years', 'description': 'TOS was defined as time from diagnostic date through the date of death due to any reasons. For all other participants, the last follow-up available was taken as the last control. If the participant had not completed the study, the date of the last visit available was considered.'}], 'secondaryOutcomes': [{'measure': 'Induced remission rate (CR)', 'timeFrame': '3 years', 'description': 'According to the time point specified in the treatment plan (22 days after the end of induction I, 29-43 days after the end of induction II and before each consolidation scheme) bone marrow puncture and lumbar puncture were performed. The follow-up contents included the detection of the count of primitive / immature lymphocytes and flow MRD. If there was a positive gene at the onset, the quantitative monitoring of the gene should be performed as MRD data at the same time. If the gene cannot be analyzed quantitatively, PCR qualitative analysis should still be performed as the monitoring basis'}, {'measure': 'Safety,including cumulative infection incidence, adverse reaction and chemotherapy-related mortality (TRD)', 'timeFrame': '3 years', 'description': 'During treatment, closely monitor relevant laboratory tests, register adverse reaction records, and report the records according to the requirements of CRF form.'}, {'measure': 'Event-free survival (EFS)', 'timeFrame': '3 years', 'description': 'EFS was estimated from date of diagnosis until date of one of the following events: relapse, refractory disease, second malignancy or death from any reason.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute monocytic leukemia', 'pediatric', 'Cladribine', 'sorafenib'], 'conditions': ['Leukemia, Monocytic, Acute', 'Pediatric AML']}, 'referencesModule': {'references': [{'pmid': '32216042', 'type': 'BACKGROUND', 'citation': 'Liu LP, Zhang AL, Ruan M, Chang LX, Liu F, Chen X, Qi BQ, Zhang L, Zou Y, Chen YM, Chen XJ, Yang WY, Guo Y, Zhu XF. Prognostic stratification of molecularly and clinically distinct subgroup in children with acute monocytic leukemia. Cancer Med. 2020 Jun;9(11):3647-3655. doi: 10.1002/cam4.3023. Epub 2020 Mar 26.'}, {'pmid': '31279288', 'type': 'RESULT', 'citation': 'Weis TM, Marini BL, Bixby DL, Perissinotti AJ. Clinical considerations for the use of FLT3 inhibitors in acute myeloid leukemia. Crit Rev Oncol Hematol. 2019 Sep;141:125-138. doi: 10.1016/j.critrevonc.2019.06.011. Epub 2019 Jun 28.'}, {'pmid': '19242495', 'type': 'RESULT', 'citation': 'Rubnitz JE, Crews KR, Pounds S, Yang S, Campana D, Gandhi VV, Raimondi SC, Downing JR, Razzouk BI, Pui CH, Ribeiro RC. Combination of cladribine and cytarabine is effective for childhood acute myeloid leukemia: results of the St Jude AML97 trial. Leukemia. 2009 Aug;23(8):1410-6. doi: 10.1038/leu.2009.30. Epub 2009 Feb 26.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, single arm, prospective, intervention trial. Since cladribine can enhance the biological activity and self-protection of cytarabine, giving cladribine and cytarabine together may kill more cancer cells. 10 centers from South China Childhood Leukaemia Collaborative Group carry out the SCCLG-M5-2022 regimen including two courses of CLAG(cladribine, darubicin and cytarabine) in the induction period for the treatment of newly dignosed acute monocytic leukemia (M5). The targeted drugs sorafenib is used for FLT3 positive acute monocytic leukemia to inhibit the serine / threonine kinase activity of FLT3.', 'detailedDescription': 'PRIMARY OBJECTIVES\n\n1.To study the 3 year-overall survival of newly diagnosed monocytic leukemia treated with Cladribine and cytarabine in children.\n\nSECONDARY OBJECTIVES\n\n1. To describe the complete response rate following CLAG (cladribine, cytarabine and granulocyte stimulating factor) in newly diagnosed monocytic leukemia in children for intensive induction therapy.\n2. To evaluate the 3-year progression-free survival in response to CLAG in children.\n3. To assess the toxicity of CLAG including cumulative infection incidence, cumulative adverse effects and chemotherapy-related mortality (TRD).\n4. To study the progression-free survival and overall survival (1 year, 2 year and 3 year) of newly diagnosed monocytic leukemia with positive FLT3 treated with CLAG in children and the side effects of sorafenib.\n\nOUTLINE:\n\n1. The induction phase includes two parts including induction therapy I(CLAG) and induction therpay II(CLAG+I/M).\n2. The diagnosis and classified criteria is according to the 2016 WHO classification criteria for hematopoietic and lymphoid tissue tumors, and the consolidation therapy consists the therapeutic phases as the NOPHO-AML 2004 protocol prescribed.\n\n INDUCTION THERAPY I: Patients receive cladribine intravenously (IV) at a dose of 5mg/m2/day combined with cytarabine 2g/m2/day on day 1-5 and granulocyte stimulating factor 5ug/kg/day on day 0-6. When blood count recover(WBC\\>2.0×109/L， ANC1.0×109/L、PLT≥50×109/L) , Patients achieving a morphological leukemia free state (\\< 5% blasts) or MRD\\< 1% receive a second course treatment as above.\n\n INDUCTION THERPAY II: Patients receive cladribine intravenously (IV) at a dose of 5mg/m2/day combined with cytarabine 2g/m2/day on day 1-5, mitoxantrone/idarubicin 10mg/m2/day on day 1-3 and granulocyte stimulating factor 5ug/kg/day on day 0-6. Patients achieving blast count≥5% or MRD ≥1% proceed to induction II therpy.\n3. For FLT3 positive acute monocytic leukemia children, sorafenib 200mg/m2/day was taken orally until molecular biology remission for 2 years.\n4. After two courses of indution phase, patients with incomplete response（MRD≥0.1%）are recommended into hematopoietic stem cell transplantation.\n5. After two courses of indution phase, patients with persisting positive adverse prognosis cytogenetic abnormalities are recommended into hematopoietic stem cell transplantation.\n\nPatients must meet one of the following risk criteria:\n\nStandard-risk (SR) group meeting all of the following criteria:\n\nInitial WBC \\< 10,000/μL\n\nM1 (\\<5%) blasts or MRD\\<1% in bone marrow after the first course of induction therapy\n\nM1 (\\<5%) blasts or MRD\\<0.1% in bone marrow after two courses of induction therapy\n\nCytogenetic abnormalities with good prognosis\n\nIntermediate-risk (IR) group meeting the following criteria:\n\nLack of low-risk and high-risk conditions\n\nHigh-risk (HR) group meeting ≥ 1 of the following criteria:\n\nM2/M3(≥5%) blasts or MRD\\>5% in bone marrow after the first course of induction therapy\n\nMRD≥0.1% in bone marrow after two course of induction therapy\n\nCytogenetic abnormalities with poor prognosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n0-14 years old\n\nCytologically proven acute monocytic leukemia (M5) with other treatment\n\nExclusion Criteria:\n\nSecondary to immunodeficiency or MDS\n\nSecond tumor\n\nDowm's syndrome\n\nEvolution of chronic myelogenous leukemia to blast crisis\n\nDeath or quit treatment in seven days at the begining of induction therapy\n\nTreatment with other effective chemotherapy drugs for AML, excluding the low dose chemotherapy for the purpose of reducing leukocytes in hyperleukocytic leukemia\n\nConcurrent severe and/or uncontrolled medical condition (e.g. uncontrolled heart, brain, liver and kidney failure etc.)\n\nAny psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule"}, 'identificationModule': {'nctId': 'NCT05313958', 'acronym': 'SCCLG-M5', 'briefTitle': 'Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}, 'officialTitle': 'Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children： A Prospective Multicenter Study in South China', 'orgStudyIdInfo': {'id': '2021-KY-052'}, 'secondaryIdInfos': [{'id': '2021A1515011809', 'type': 'OTHER_GRANT', 'domain': 'Province natural science fund of Guangdong'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment arm', 'description': 'The patients in this arm will receive SCCLG-M5 2022 regimen for newly dignosed acute monocytic leukemia (M5) ,including two courses of CLAG(cladribine, darubicin and cytarabine) in the induction period and followed by three courses(HA1M, HA2E, HA3) in consolidation therapy prescribed as the NOPHO-AML 2004 protocol.\n\nThe targeted drugs sorafenib 200mg/m2/day orally is used for FLT3 positive acute monocytic leukemia until molecular biology remission for 2 years.', 'interventionNames': ['Drug: Cladribine', 'Drug: G-CSF', 'Drug: Cytarabine', 'Drug: Idarubicin', 'Drug: Mitoxantrone', 'Drug: Sorafenib']}], 'interventions': [{'name': 'Cladribine', 'type': 'DRUG', 'otherNames': ['cladribine injection'], 'description': '5mg/㎡/day d1-5 in 2 hours, before the use of Cytarabine', 'armGroupLabels': ['treatment arm']}, {'name': 'G-CSF', 'type': 'DRUG', 'otherNames': ['granulocyte'], 'description': '5ug/kg/day d0-5,if Peripheral blood leukocytes\\<20,000/ul', 'armGroupLabels': ['treatment arm']}, {'name': 'Cytarabine', 'type': 'DRUG', 'otherNames': ['Ara-C'], 'description': '2g/㎡/day d1-5 in 4 hours, after the use of Cladribine', 'armGroupLabels': ['treatment arm']}, {'name': 'Idarubicin', 'type': 'DRUG', 'otherNames': ['Idamycin', 'IDA'], 'description': 'Idarubicin 10mg/m2/day or mitoxantrone 10mg/m2/day on day 1-3 in the induction therapy II', 'armGroupLabels': ['treatment arm']}, {'name': 'Mitoxantrone', 'type': 'DRUG', 'otherNames': ['MIT'], 'description': 'Idarubicin 10mg/m2/day or mitoxantrone 10mg/m2/day on day 1-3 in the induction therapy II', 'armGroupLabels': ['treatment arm']}, {'name': 'Sorafenib', 'type': 'DRUG', 'otherNames': ['sorafinib', 'Nexavar', 'sorafenib tosylate'], 'description': '200mg/m2/day was taken orally until molecular biology remission for 2 years', 'armGroupLabels': ['treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Foshan', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'riling chen, M.D', 'role': 'CONTACT', 'email': 'chenrl319@163.com', 'phone': '19820318067'}], 'facility': 'Maternal and Child Health Hospital of Foshan', 'geoPoint': {'lat': 23.02677, 'lon': 113.13148}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'lina wang, M.D', 'role': 'CONTACT', 'email': 'wanglina_11@yeah.net', 'phone': '18922234317'}], 'facility': "Guangzhou First People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yawei zhou, M.D', 'role': 'CONTACT', 'email': 'zywyhscg@qq.com', 'phone': '136423337577'}], 'facility': 'The First Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'huiqin chen, M.D', 'role': 'CONTACT', 'email': 'chenhuiqinchq@126.com', 'phone': '13724819908'}], 'facility': 'Third Affiliated Hospital, Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'lihua yang, M.D', 'role': 'CONTACT', 'email': 'yanglihua@163.com', 'phone': '13580532469'}], 'facility': 'Zhujiang Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Shantou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'beiyan wu, M.D', 'role': 'CONTACT', 'email': '1261305798@qq.com', 'phone': '13802336066'}], 'facility': "Guangzhou First People's Hospital First Affiliated Hospital of Shantou University Medical College", 'geoPoint': {'lat': 23.35489, 'lon': 116.67876}}, {'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'wuqing wan', 'role': 'CONTACT', 'email': 'wanwuqing65@163.com', 'phone': '13507316963'}], 'facility': 'Second Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'changda liang, M.D', 'role': 'CONTACT', 'email': 'liangchangda@163.com', 'phone': '13879175309'}], 'facility': "Jiangxi Province Children's Hospital Southern Medical University, China", 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'qiwen chen, M.D', 'role': 'CONTACT', 'email': '13970807656@163.com', 'phone': '13970807656'}], 'facility': 'The First Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}], 'centralContacts': [{'name': 'dunhua zhou, M.D', 'role': 'CONTACT', 'email': 'zdunhua@163.com', 'phone': '13560099258'}], 'overallOfficials': [{'name': 'dunha zhou, M.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Third Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Maternal and Child Health Hospital of Foshan', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, {'name': 'Second Xiangya Hospital of Central South University', 'class': 'OTHER'}, {'name': "Jiangxi Province Children's Hospital", 'class': 'OTHER'}, {'name': 'Southern Medical University, China', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Nanchang University', 'class': 'OTHER'}, {'name': "Guangzhou First People's Hospital", 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Shantou University Medical College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}