Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT05339204
Status:
RECRUITING
Last Update Posted:
2022-04-21
First Post:
2022-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of Allo-HSCT in MRD-negative Patients With AML Under the Age of 60 Years in the First Complete Remission
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-14', 'studyFirstSubmitDate': '2022-04-14', 'studyFirstSubmitQcDate': '2022-04-14', 'lastUpdatePostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival for AML in CR1 with MRD-negativity after first course of chemo', 'timeFrame': '5 years'}, {'measure': 'Relapse probability', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '5 years'}, {'measure': 'Disease-free survival', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AML, MRD, allo-HSCT, CR1, adult'], 'conditions': ['AML']}, 'descriptionModule': {'briefSummary': 'Depending on the variant of the disease, patients are divided into 3 groups: A, B and C. Group A include patients with acute myeloid leukemia (AML) inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11, group B - AML with t(8;21)(q22;q22.1); RUNX1-RUNX1T1, AML with normal karyotype with or without gene mutations (FLT3, NPM1, CEBPa) regardless of the allele ratio, and also AML with cytogenetic abnormalities not classified as those within groups A/C, group C - AML with myelodysplasia-related changes. Patients from group A receive treatment according to the scheme: 2 courses "7+3", 2 courses "FLAG", then - 6 courses of maintenance therapy according to the scheme "5+5". Patients from group B are given one course of "7+3". After that, their minimal residual disease (MRD) status is assessed. In case MRD negativity is achieved after the 1st course of "7 +3", randomization is carried out: branch 1 - therapy is similar to therapy for patients from group A (4 courses of induction and consolidation + 6 courses of maintenance chemotherapy (CT), allogeneic hematopoietic stem cell transplantation (allo-HSCT) is not planned), branch 2 - performing allo-HSCT should be done as soon as possible (before the start of maintenance CT is most desirable). If MRD negativity is not achieved after the 1st course of "7+3", the patient is given CT according to the standard program, followed by mandatory allo-HSCT. Patients from group C are treated either according to the "Aza-Ida-Ara-C" scheme, or according to the "Ven-DAC /AZA" scheme, followed by mandatory allo-HSCT.', 'detailedDescription': '"7+3" regimen:\n\n1. Cytarabine 200 mg/m2 (IV continuous infusion over 24 hours), days 1-7\n2. Daunorubicin 60 mg/m2 (IV bolus), days 1-3\n\n"FLAG" regimen:\n\n1. Fludarabine 25 mg/m2 (IV in 30 minutes), days 1-5\n2. Cytarabine 1500 mg/m2 (IV in 3 hours), days 1-5\n3. Granulocyte colony-stimulating factor 5 mcg/kg (subcutaneous injection), from day 6 until regression of cytopenia\n\n"Aza-Ida-Ara-C" regimen:\n\n1. Azacitidine 75 mg/m2 (subcutaneous injection), days 1-3\n2. Idarubicin 3 mg/m2 (IV bolus), days 4-10\n3. Cytarabine 15 mg/m2 twice a day (subcutaneous injection), days 4-17\n\n"Ven-DAC/AZA"\n\n1. Venetoclax 400 mg once daily (PO), days 1-28\n2. Either Azacitidine or Decitabine Azacitidine 75 mg/m2 (subcutaneous injection), days 1-7 Decitabine 20 mg/m2 (IV in 60 minutes). days 1-5\n\n"5+5" regimen\n\n1. Cytarabine 50 mg/m2 twice a day (subcutaneous injection), days 1-5\n2. Mercaptopurine 30 mg/m2 twice a day (PO), days 1-5'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Newly diagnosed, previously untreated AML;\n2. Age from 18 to 59 years;\n3. Somatic status - ECOG \\< 3.\n\nExclusion Criteria:\n\n1. previous chemotherapy for AML;\n2. pregnancy;\n3. relapses and refractory forms of AML;\n4. acute promyelocytic leukemia;\n5. blast crisis of chronic myeloid leukemia;\n6. de novo AML with t(9;22);\n7. AML transformed from MDS or MPN after treatment, for which a different protocol is provided;\n8. Blastoid plasmacytoid dendritic cell neoplasia (with the exception of cases when a small population of plasmacytoid dendritic progenitors is detected in the leukemic neoplasia).\n9. Undifferentiated acute leukemia'}, 'identificationModule': {'nctId': 'NCT05339204', 'briefTitle': 'The Role of Allo-HSCT in MRD-negative Patients With AML Under the Age of 60 Years in the First Complete Remission', 'organization': {'class': 'NETWORK', 'fullName': 'National Research Center for Hematology, Russia'}, 'officialTitle': 'Prospective Multicenter Randomized Controlled Clinical Trial for Evaluation the Role of Allo-HSCT in the First Complete Remission, MRD-negative After the First Course, in Patients With AML Under the Age of 60 Years', 'orgStudyIdInfo': {'id': 'AML-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'allo-HSCT', 'description': 'Patients with AML in CR1, MRD-negative after first course recieve allo-HSCT', 'interventionNames': ['Procedure: allo-HSCT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chemo', 'description': 'Patients with AML in CR1, MRD-negative after first course continue chemotherapy', 'interventionNames': ['Procedure: allo-HSCT']}], 'interventions': [{'name': 'allo-HSCT', 'type': 'PROCEDURE', 'description': 'allo-HSCT from any type of donor', 'armGroupLabels': ['Chemo', 'allo-HSCT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Elena Parovichnikova', 'role': 'CONTACT'}], 'facility': 'National Research Center for Hematology', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Irina Lukianova, MD PhD', 'role': 'CONTACT', 'email': 'Irina.donskova99@mail.ru', 'phone': '+79653493473'}, {'name': 'Anastasia Kashlakova, MD', 'role': 'CONTACT', 'email': 'salvatorvaltz@gmail.com', 'phone': '+74956124592'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Research Center for Hematology, Russia', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Botkin Hospital', 'class': 'OTHER'}, {'name': 'St. Petersburg State Pavlov Medical University', 'class': 'OTHER'}, {'name': 'Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health', 'class': 'OTHER'}, {'name': 'Federal Research Clinical Center of Federal Medical & Biological Agency, Russia', 'class': 'OTHER_GOV'}, {'name': 'Regional Clinical Hospital of Yaroslavl', 'class': 'UNKNOWN'}, {'name': 'Nizhny Novgorod regional clinical hospital named after N.A.Semashko', 'class': 'UNKNOWN'}, {'name': 'Clinical hospital №1 of Sverdlovsk region', 'class': 'UNKNOWN'}, {'name': 'Irkutsk regional clinical hospital, winner of the "Mark of the Honor" award', 'class': 'UNKNOWN'}, {'name': 'The Federal State-Financed Scientific Institution Kirov Research Institute of Hematology and Blood T', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}