Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-01-01 @ 5:44 PM
Study NCT ID:
NCT06458257
Status:
RECRUITING
Last Update Posted:
2025-07-29
First Post:
2024-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Allogeneic Hematopoietic Stem Cell Transplantation in Newly Diagnosed High-relapse-risk CEBPA Mutant Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'bone marrow; peripheral blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2024-01-09', 'studyFirstSubmitQcDate': '2024-06-09', 'lastUpdatePostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease-free-survival', 'timeFrame': 'from data of AML diagnosis until the data of AML relapse, assessed up to 3 years', 'description': 'disease-free-survival'}, {'measure': 'The relation of CEBPA Mutant AML genetics subgroup with MRD negativity rate after chemotherapy and DFS after transplantation', 'timeFrame': 'from enrollment to study completion, a maximum of 3 years', 'description': 'The relation of CEBPA Mutant AML genetics subgroup with MRD negativity rate after chemotherapy and DFS after transplantation'}], 'secondaryOutcomes': [{'measure': 'non-relapse-mortality', 'timeFrame': 'from enrollment to study completion, a maximum of 3 years', 'description': 'non-relapse-mortality'}, {'measure': 'overall survival', 'timeFrame': 'from enrollment to study completion, a maximum of 3 years', 'description': 'overall survival'}, {'measure': 'adverse events', 'timeFrame': 'from enrollment to study completion, a maximum of 3 years', 'description': 'adverse events'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['newly diagnosed; high-relapse-risk; CEBPA mutant'], 'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'For newly diagnosed high-relapse-risk CEBPA mutant acute myeloid leukemia patients, we aim to perform allogeneic hematopoietic stem cell transplantation after patients finished one cycle of induction and two cycles of consolidation. To access whether the therapeutic regimen is effective for high-relapse-risk CEBPA mutant acute myeloid leukemia, the disease-free-survival (DFS), overall survival (OS), non-relapse-mortality of patients is evaluated.', 'detailedDescription': 'High-relapse-risk definition:\n\nParticipants with non-bZIP in-frame mutations, WT1 mutated status or CD7 negative status are considered of high-relapse-risk; The positive threshold for flow cytometry MRD was 0.0001%; The MRD threshold of molecular biology is the lowest value of the detection protocol of the center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients Diagnosed in Ruijin Hospital', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with confirmed CEBPA mutant AML. Diagnostic criteria include the presence of CEBPA mutant gene detected at the molecular level;\n2. Patients with high-risk molecular markers or gene mutations, or complex karyotypes for disease recurrence, or flow cytometry/gene MRD positivity after two chemotherapy treatments; high-risk molecular markers or gene mutations include: CD7 positive, WT1 mutation, non-bzip-inframe CEBPA mutation; The positive threshold for flow cytometry MRD was 0.0001%; The MRD threshold of molecular biology is the lowest value of the detection protocol of the center.\n3. Medical history and diagnosis of MICM, exclusion of MDS, transformation and treatment-related AML;\n4. Age 18-65 years old (18 years old ≤Age\\< 65 years old);\n5. Liver and kidney function: blood bilirubin ≤ 35 μmol/L, AST/ALT below 2 times the upper limit of normal, serum creatinine ≤ 150 μmol/L;\n6. Normal cardiac function (EF≥50%, New York Cardiac Function Classification NYHA I/II);\n7. Physical condition score 0-2 (ECOG score);\n8. For patients with peripheral blood leukocytes \\< 50\\*109/L at the initial onset, no chemotherapy has been given except for hydroxyurea before the start of induction therapy;\n9. For patients with peripheral blood leukocytes ≥ 50\\*109/L at the initial onset, cytarabine and hydroxyurea are allowed to be treated before the start of induction therapy;\n10. Non-pregnant and lactating women;\n11. For all women of childbearing age, a pregnancy test must be performed to measure hCG to rule out pregnancy;\n12. Obtain informed consent signed by the patient or family member.\n\nExclusion Criteria:\n\n1. MDS-converted AML, treatment-related AML; mixed cell leukemia; AML patients with central nervous system infiltrates and extramedullary lesions at the time of onset;\n2. Relapse patients;\n3. Allergies or contraindications to any of the drugs involved in the protocol;\n4. Liver and kidney function are obviously abnormal, exceeding the enrollment criteria;\n5. Cardiac disease: including echocardiogram EF \\<50%, cardiac insufficiency (New York cardiac function classification NYHA: III/IV), pericardial effusion (CTCAE score \\>2) within six months after acute myocardial infarction, ECG QTc \\>470ms;\n6. Lung diseases: pulmonary edema, pleural effusion (CTCAE score \\>2);\n7. Suffering from malignant tumors of other organs at the same time;\n8. Active patients with HAV, HBV, HCV and tuberculosis, HIV-positive patients;\n9. Concomitant other hematologic diseases (including coagulation abnormalities unrelated to leukemia);\n10. Inability to understand or follow the study protocol;\n11. Those who participate in other clinical studies at the same time; Presence of any other condition that would preclude the conduct of the study'}, 'identificationModule': {'nctId': 'NCT06458257', 'briefTitle': 'The Efficacy of Allogeneic Hematopoietic Stem Cell Transplantation in Newly Diagnosed High-relapse-risk CEBPA Mutant Acute Myeloid Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'The Efficacy of Allogeneic Hematopoietic Stem Cell Transplantation in Newly Diagnosed High-relapse-risk CEBPA Mutant Acute Myeloid Leukemia', 'orgStudyIdInfo': {'id': 'CEBPA-AML01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HSCT-group', 'description': 'patients received allogeneic hematopoietic stem cell transplantation after consolidation treatment', 'interventionNames': ['Procedure: Allogeneic Hematopoietic Stem Cell Transplantation']}, {'label': 'Chemo-group', 'description': 'patients received chemotherapy after consolidation treatment', 'interventionNames': ['Drug: Chemotherapy']}], 'interventions': [{'name': 'Allogeneic Hematopoietic Stem Cell Transplantation', 'type': 'PROCEDURE', 'description': 'Allogeneic Hematopoietic Stem Cell Transplantation', 'armGroupLabels': ['HSCT-group']}, {'name': 'Chemotherapy', 'type': 'DRUG', 'description': 'Chemotherapy', 'armGroupLabels': ['Chemo-group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian Li, PhD', 'role': 'CONTACT', 'email': 'lj12116@rjh.com.cn', 'phone': '02164370045'}, {'name': 'Yang Shen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ruijin Hospital Affiliated to Shanghai Jiaotong University School Of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Shen yang', 'investigatorAffiliation': 'Ruijin Hospital'}}}}