Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:27 PM
Study NCT ID:
NCT07211958
Status:
RECRUITING
Last Update Posted:
2025-12-08
First Post:
2025-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation
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': 'C000728983', 'term': 'revumenib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 468}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT05918913', 'statusForNctId': 'NO_LONGER_AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2031-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2025-09-30', 'studyFirstSubmitQcDate': '2025-10-01', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event Free Survival', 'timeFrame': 'Up to 2 years'}, {'measure': 'Measurable Residual Disease Complete Remission Rate', 'timeFrame': 'Up to 2 years'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Up to 5 years'}, {'measure': 'Rate of Complete Remission', 'timeFrame': 'Up to 2 years'}, {'measure': 'Overall Response Rate', 'timeFrame': 'Up to 2 years'}, {'measure': 'Duration of Complete Remission', 'timeFrame': 'Up to 2 years'}, {'measure': 'Duration of Composite Complete Remission', 'timeFrame': 'Up to 2 years'}, {'measure': 'Duration of Response', 'timeFrame': 'Up to 2 years'}, {'measure': 'Number of Participants with a Treatment-emergent Adverse Event', 'timeFrame': 'Up to 2 years'}, {'measure': 'Change from Baseline in Patient-reported Fatigue Questionnaire Scores', 'timeFrame': 'Up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SNDX-5613', 'Nucleophosmin 1', 'NPM1', 'Acute Myeloid Leukemias', 'AML', 'Revumenib', 'Newly diagnosed AML'], 'conditions': ['Acute Myeloid Leukemias']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess if adding revumenib to standard chemotherapy improves outcomes in participants with AML with certain genetic mutations compared to chemotherapy alone. The study will also assess the safety of adding revumenib to chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Participants must have newly diagnosed and previously untreated AML and be candidates for intensive chemotherapy.\n* Presence of an NPM1 mutation.\n* Eastern Cooperative Oncology Group performance status ≤2 (≤1 if \\>65 years old); Karnofsky or Lansky ≥40.\n* Have a life expectancy of ≥3 months as judged by the Investigator.\n* Negative serum pregnancy test.\n* Adequate liver, kidney, and cardiac function.\n\nKey Exclusion Criteria:\n\n* Diagnosis of active acute promyelocytic leukemia.\n* Active central nervous system disease.\n* Fridericia's corrected QT interval (QTcF) \\>450 milliseconds at screening, diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome.\n* Any gastrointestinal (GI) issue of the upper GI tract likely to affect oral drug absorption or ingestion.\n* Any concurrent malignancy requiring active therapy (except breast or prostate cancer stable on or responding to endocrine therapy).\n* Inability to swallow oral medication.\n* Pregnant or nursing females.\n* Participant has known active or chronic hepatitis B or active hepatitis C (HCV) infection or human immunodeficiency virus (HIV)-positive with detectable viral load.\n\nNote: Additional inclusion/exclusion criteria may apply, per protocol."}, 'identificationModule': {'nctId': 'NCT07211958', 'acronym': 'REVEAL-ND NPM1', 'briefTitle': 'Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Syndax Pharmaceuticals'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Revumenib in Combination With Intensive Chemotherapy in Participants With Newly Diagnosed AML With an NPM1 Mutation', 'orgStudyIdInfo': {'id': 'SNDX-5613-0710'}, 'secondaryIdInfos': [{'id': '2025-522279-27-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Revumenib + Intensive Chemotherapy', 'description': 'Participants will receive revumenib plus an intensive chemotherapy regimen.', 'interventionNames': ['Drug: Revumenib', 'Drug: Intensive Chemotherapy Regimen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + Intensive Chemotherapy', 'description': 'Participants will receive placebo plus an intensive chemotherapy regimen.', 'interventionNames': ['Drug: Placebo', 'Drug: Intensive Chemotherapy Regimen']}], 'interventions': [{'name': 'Revumenib', 'type': 'DRUG', 'otherNames': ['SNDX-5613'], 'description': 'Participants will receive revumenib orally.', 'armGroupLabels': ['Revumenib + Intensive Chemotherapy']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will receive placebo (non-active agent) orally.', 'armGroupLabels': ['Placebo + Intensive Chemotherapy']}, {'name': 'Intensive Chemotherapy Regimen', 'type': 'DRUG', 'description': 'Participants will receive an intensive chemotherapy regimen of cytarabine and daunorubicin by intravenous (IV) infusion.', 'armGroupLabels': ['Placebo + Intensive Chemotherapy', 'Revumenib + Intensive Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6000', 'city': 'Batumi', 'state': 'Adjara', 'status': 'RECRUITING', 'country': 'Georgia', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 41.64077, 'lon': 41.6306}}, {'zip': '0159', 'city': 'Tbilisi', 'status': 'RECRUITING', 'country': 'Georgia', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}], 'centralContacts': [{'name': 'Syndax Pharmaceuticals', 'role': 'CONTACT', 'email': 'clinicaltrials@syndax.com', 'phone': '781-419-1400'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Syndax Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}