Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT06802718
Status:
RECRUITING
Last Update Posted:
2025-01-31
First Post:
2024-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interferon-alpha As Maintenance Therapy for Favorable-risk 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': 'D007372', 'term': 'Interferons'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-25', 'studyFirstSubmitDate': '2024-12-21', 'studyFirstSubmitQcDate': '2025-01-25', 'lastUpdatePostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6-month negative conversion of MRD', 'timeFrame': 'Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.', 'description': 'MFC-MRD or RT-PCR genes (AML1-ETO, NPM1, and CBFb-MYH11) transition from positive to negative.'}], 'secondaryOutcomes': [{'measure': 'CIR', 'timeFrame': 'Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.', 'description': 'The number of patients with relapse calculated from the randomization time to the last follow-up time.'}, {'measure': 'EFS', 'timeFrame': 'Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.', 'description': 'Events include treatment failure (MRD positivity or molecular progression), relapse, or death from any cause.'}, {'measure': 'OS', 'timeFrame': 'Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.', 'description': 'calculated from randomization time to the time of death or the last follow-up time.'}, {'measure': 'Treatment-related Safety Indicators', 'timeFrame': 'Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.', 'description': 'Mainly include hematologic toxicity and liver toxicity.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'This research focuses on a prospective, randomized, controlled trial of "Interferon-alpha as maintenance therapy for favorable-risk acute myeloid leukemia." By fully utilizing prospective, randomized, controlled clinical trial and studying the negative conversion of MRD and the survival of favorable-risk AML patients, it aims to explore the efficacy and safety of Interferon-alpha in the maintenance treatment of favorable-risk AML and identify effective measures to prevent relapse, thereby improving the survival of favorable-risk AML patients. The primary endpoint is the negative conversion of MRD at 6 months. The secondary endpoints include the 2-year cumulative incidence of relapse, 2-year event-free survival (EFS), 2-year overall survival (OS), and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-70 years old (including 18 and 70 years old) with newly diagnosed favorable-risk AML (2022 ELN risk group classification).\n* Achieved CR1 after 1-2 cycles of standard chemotherapy.\n* Completed 4-6 cycles of consolidation chemotherapy (including at least 2 cycles of high-dose Cytarabine HDAC regimem).\n* At the end of consolidation treatment, bone marrow examination confirmed in CR1, flow cytometry MRD negative, but molecular MRD genes (RUNX1:: RUNX1T1, NPM1, and CBFb:: MYH11) decreased by \\> 3 log, but still detectable.\n* Performance status score of 0-2 (ECOG).\n* Liver function: ALT and AST ≤ 2.5 times the upper limit of normal, bilirubin ≤ 2 times the upper limit of normal.\n* Kidney function: Creatinine ≤ 1.5 times the upper limit of normal.\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia (APL).\n* AML with normal karyotype and bZIP intramolecular mutations in CEBPA.\n* ≥ CR2 status.\n* Patients strongly demanding transplantation, and with indications for transplantation but not eligible for transplantation.\n* Uncontrolled active infection.\n* Severe organ dysfunction.\n* Pregnancy.\n* Unwillingness to undergo interferon treatment.\n* Previous hyperthyroidism or hypothyroidism.\n* Participation in other clinical trials within one month.'}, 'identificationModule': {'nctId': 'NCT06802718', 'briefTitle': 'Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'A Prospective Randomized Controlled Trial of Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia', 'orgStudyIdInfo': {'id': '2023PHD001-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interferon Group', 'description': 'Polyethylene glycol interferon alpha-2b injection 135 μg/week was subcutaneously given for 6 months.', 'interventionNames': ['Drug: Interferon']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Observational follow-up without receiving any maintenance treatment.'}], 'interventions': [{'name': 'Interferon', 'type': 'DRUG', 'description': 'Polyethylene glycol interferon alpha-2b injection 135 μg/week was subcutaneously given for 6 months.', 'armGroupLabels': ['Interferon Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Feifei Tang', 'role': 'CONTACT', 'email': 'bjmugirl@163.com', 'phone': '13581671687'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Feifei Tang, Prof', 'role': 'CONTACT', 'email': 'bjmugirl@163.com', 'phone': '13581671687'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Xiao-Jun Huang', 'investigatorAffiliation': "Peking University People's Hospital"}}}}