Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-02-12 @ 8:35 AM
Study NCT ID:
NCT06452732
Status:
RECRUITING
Last Update Posted:
2024-12-05
First Post:
2024-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Multiparametric Flow Cytometry to Detect Peripheral Blood and Bone Marrow Leukaemia Stem Cells for Relapse Prediction in P-AML
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'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'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 283}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2024-06-05', 'studyFirstSubmitQcDate': '2024-06-05', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary end point was cumulative incidences of relapse (CIR)', 'timeFrame': '2 years', 'description': 'Relapse was defined by the morphological evidence of disease in the peripheral blood, BM or extramedullary sites. Time to relapse was defined from the date of diagnosis to the date of disease recurrence. Patients exhibiting minimal residual disease were not classified as having relapsed.'}], 'secondaryOutcomes': [{'measure': 'Leukemia free survival (LFS)', 'timeFrame': '2 years', 'description': 'Leukimia-free survival was defined as days from diagnosis to disease progression after transplantation.'}, {'measure': 'Overall survival (OS)', 'timeFrame': '2 years', 'description': 'Overall survival referred to patients who survived until the final follow-up time point.'}, {'measure': 'Non-relapse mortality (NRM)', 'timeFrame': '2 years', 'description': 'Non-relapse mortality was defined as all causes of death other than those related directly to malignant disease itself, occurring at any time after CR.'}, {'measure': 'Transplant related mortality (TRM)', 'timeFrame': '2 years', 'description': 'Transplant-related mortality was defined as all causes of death other than those related directly to malignant disease itself, occurring at any time after transplantation.'}, {'measure': 'Acute GVHD', 'timeFrame': '2 years', 'description': 'Acute GVHD was defined and graded from 0 to IV based on the pattern and severity of organ involvement\\[Sullivan KM. Graft-versus-host-disease. In: Thomas ED, Blume KG, Forman SJ (eds). Hematopoietic Cell Transplantation. 2nd edn. Blackwell Science: Boston, MA, USA, 1999, pp 515-536.\\]; grades III-IV aGVHD manifest as serious clinical features on the skin, liver and/or gut.'}, {'measure': 'Chronic GVHD', 'timeFrame': '2 years', 'description': 'Chronic GVHD was defined and graded according to the National Institute of Health criteria:\\[Biol Blood Marrow Transplant,2005,11: 945\\] that is, mild cGVHD reflects the involvement of no more than 1 or 2 organs/sites (except for lung) with a maximum score of 1; moderate cGVHD involves at least 1 organ/site with a score of 2 or ≥3 organs/sites with a score of 1 (or lung score 1); and severe cGVHD is diagnosed when a score of 3 is given to any organ (or lung score 2). The diagnosis is mainly based on clinical manifestations.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia', 'Acute Lymphoblastic Leukemia']}, 'descriptionModule': {'briefSummary': 'Leukaemia is a major disease that seriously endangers human health, the long-term survival rate of acute myeloid leukaemia receiving conventional chemotherapy is only 10% to 45%, haematological relapse is the main cause of treatment failure in acute myeloid leukaemia, reducing the relapse rate is the key to improving the efficacy of acute leukaemia, biomarker-guided preemptive therapy is an effective way to reduce the recurrence of leukaemia, existing markers to predict the recurrence has a high false Existing markers have high false-negative and false-positive rates for predicting relapse, and improving the accuracy of leukaemia relapse prediction is a major clinical problem that needs to be solved urgently. The group has found that circulating leukaemia stem cells remaining after chemotherapy are the key to relapse, therefore, we propose to conduct a multicentre prospective clinical study on the prediction of acute leukaemia relapse by circulating leukaemia stem cells.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study was an exploratory study in search of new biomarkers, based on the previous literature, the recurrence rates of pre-transplant MRD (+) and MRD (-) in pediatric AML were 41% and 23.8% respectively (Br J Haematol.2024;204:585-594), with the ratio of patients in the two groups being 1:1.The calculation was done using PASS 15.0 assuming a two-sided test of α=0.05 and a test efficacy of = 1-β=80%, with the number of people needed being 226, taking into account a 20% censoring rate, the final total sample size was 283 patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnoses candidates with acute myeloid leukemia.\n* Lower than or equal to 18 years-old;\n* Subjects are able to provide written informed consent.\n\nExclusion Criteria:\n\n* Subjects who cannot comply with the study;\n* Subjects with severe cardiac disease (ejection fraction\\<50% ), liver disease (total bilirubin \\>34umol/L, ALT and AST\\>1.5×upper limit normal) or kidney disease (Serum creatinine\\>130umol/L).\n* Subjects with severe infection.\n* Subjects with other conditions that cannot receive chemotherapy or transplantation.'}, 'identificationModule': {'nctId': 'NCT06452732', 'briefTitle': 'Using Multiparametric Flow Cytometry to Detect Peripheral Blood and Bone Marrow Leukaemia Stem Cells for Relapse Prediction in P-AML', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Using Multiparametric Flow Cytometry to Detect Peripheral Blood and Bone Marrow Leukaemia Stem Cells for Relapse Prediction in Pediatric Acute Myeloid Leukaemia: a Prospective Study', 'orgStudyIdInfo': {'id': 'PekingUPH Chang Ying-Jun'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MRD monitoring', 'interventionNames': ['Other: MFC for the determination of leukemia stem cell']}], 'interventions': [{'name': 'MFC for the determination of leukemia stem cell', 'type': 'OTHER', 'description': 'MFC for the determination of leukemia stem cell', 'armGroupLabels': ['MRD monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying-Jun Chang', 'role': 'CONTACT', 'email': 'rmcyj@bjmu.edu.cn', 'phone': '8610-88325949'}], 'facility': "People's Hospital of Peking University", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yingjun Chang Y Prof. Ying-Jun Chang Chang', 'role': 'CONTACT', 'email': 'rmcyj@bjmu.edu.cn', 'phone': '8610-88325949'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Chang Yingjun', 'investigatorAffiliation': "Peking University People's Hospital"}}}}