Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-30 @ 10:19 PM
Study NCT ID:
NCT06569095
Status:
RECRUITING
Last Update Posted:
2024-12-20
First Post:
2024-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Value of Myelodysplastic Syndrome Stem Cells Determined by Multiparameter Flow Cytometry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 163}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-12-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-17', 'studyFirstSubmitDate': '2024-07-15', 'studyFirstSubmitQcDate': '2024-08-22', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1 year-cumulative relapse rate', 'timeFrame': 'through study completion, an average of 1 year', '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 transplantation to the date of disease recurrence. Patients exhibiting minimal residual disease were not classified as having relapsed.'}], 'secondaryOutcomes': [{'measure': 'Cumulative positive rate of measurable residual disease (MRD) after transplantation', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The proportion of MRD positive patients after treatment.'}, {'measure': 'Disease-free survival (LFS)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Disease-free survival was defined as days from transplantation to disease progression after transplantation.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Overall survival referred to patients who survived until the final follow-up time point.'}, {'measure': 'Non-recurrent death (NRM)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Non-recurrent 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 death (TRM)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Transplant-related death was defined as all causes of death other than those related directly to malignant disease itself, occurring at any time after transplantation.'}, {'measure': 'Acute graft-versus-host disease (GVHD)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Acute GVHD was defined and graded from 0 to IV based on the pattern and severity of organ involvement; grades III-IV aGVHD manifest as serious clinical features on the skin, liver and/or gut.'}, {'measure': 'Chronic graft-versus-host disease (GVHD)', 'timeFrame': 'through study completion, an average of 1 year', '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': ['Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': 'Presently, multiparameter flow cytometry (MFC) and polymerase chain reaction (PCR) have been used for disease load, including measurable residual disease (MRD), monitoring in patients with myelodysplastic syndrome (MDS). MFC is the most commonly method for disease load evaluation. In patients with acute myeloid leukemia, leukemia stem cells (LSCs) determined using MFC for leukemia load and MRD detection is superior to traditional MFC method. In the investigators previous single center study, the investigators demonstrated that detection of disease load, including MRD, by MFC in patients with MDS-EB is superior to predict outcomes after allogeneic stem cell transplantation. Here, the investigators will perform a multi-center, prospective clinical trial to investigate the predictive values of MDS-SC in patients with MDS-EB who received allografting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "To determine whether there was any difference in relapse between the pre-transplant MRD-positive and -negative groups, the cumulative incidence approach was used with a test for equivalence of CIF for the difference in the Kaplan-Meier estimate of the 1-year CIR. With a planned sample size of 163 AML/MDS patients, 80% power can be achieved against the hypothesis of CIR as 18.3% and 3.6% for cases in the pre-transplant MRD-positive and -negative groups at a significance level of P = 0.05 in Student's one-tailed t-test.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Myelodysplastic syndromes;\n* Between 15 and 70 years old;\n* Subjects are able to provide written informed consent.\n\nExclusion Criteria:\n\n* Subjects who cannot comply with the study;\n* Patient has severe cardiac (ejection fraction \\<50%), hepatic (total bilirubin \\>34μmol/L, ALT, AST \\>2x upper limit of normal) or renal (blood creatinine \\>130μmol/L) disease；\n* Uncontrolled serious infection;\n* Other conditions that do not tolerate transplantation or other therapies.'}, 'identificationModule': {'nctId': 'NCT06569095', 'briefTitle': 'Predictive Value of Myelodysplastic Syndrome Stem Cells Determined by Multiparameter Flow Cytometry', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Predictive Value of Myelodysplastic Syndrome Stem Cells Determined by Multiparameter Flow Cytometry in Patients Receiving Allotransplantation: a Multi-center, Prospective Clinical Study', 'orgStudyIdInfo': {'id': 'PekingUPH Chang YJ'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MDS-EB', 'interventionNames': ['Other: Detection of MDS-SC using MFC']}], 'interventions': [{'name': 'Detection of MDS-SC using MFC', 'type': 'OTHER', 'description': 'The aim of this study is to investigate the predictive values of MDS-SC determined by MFC for patients with MDS-EB who underwent allotransplantation.', 'armGroupLabels': ['MDS-EB']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hai-Yan Zhu', 'role': 'CONTACT', 'email': 'zhy301@yeah.net', 'phone': '861013910020121'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying-Jun Chang, PhD', 'role': 'CONTACT', 'email': 'rmcyj@bjmu.edu.cn', 'phone': '861013520536738'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Wuhan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi-Cheng Zhang', 'role': 'CONTACT', 'email': 'yczhang@tjh.tjmu.edu.cn', 'phone': '18607140317'}], 'facility': 'Wuhan TongJi Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Zhengzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhi-Lei Bian, PhD', 'role': 'CONTACT', 'email': 'bianzhilei@sina.com'}], 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'chief physician', 'role': 'CONTACT', 'email': 'rmcyj@bjmu.edu.cn', 'phone': '13520536738'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University First Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, {'name': 'Wuhan TongJi Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chief Physician', 'investigatorFullName': 'Chang Yingjun', 'investigatorAffiliation': "Peking University People's Hospital"}}}}