Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-30 @ 2:36 PM
Study NCT ID:
NCT03462095
Status:
UNKNOWN
Last Update Posted:
2018-03-13
First Post:
2018-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
De-escalated Treatment Approach for Adult Ph-negative Acute Lymphoblastic Leukemia (ALL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'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'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-12', 'studyFirstSubmitDate': '2018-03-06', 'studyFirstSubmitQcDate': '2018-03-06', 'lastUpdatePostDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': '5-years', 'description': 'Impact of autologous HSCT on DFS in T-cell ALL patients'}], 'secondaryOutcomes': [{'measure': 'MRD-negativity after consolidation', 'timeFrame': '6 months', 'description': 'Minimal Residual Disease clearance on non-intensive but non-interruptive treatment'}, {'measure': 'Overall survival', 'timeFrame': '5-years', 'description': 'Impact of de-escalated approach on OS'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Precursor Cell Lymphoblastic Leukemia-Lymphoma']}, 'descriptionModule': {'briefSummary': 'No high-dose methotrexate (MTX) and high-dose cytarabine (ARA-C) consolidation blocks, L-asparaginaseis scheduled for 1 year of treatment, 21 intrathecal injections through the whole treament, T-ALL patients in complete remossion (CR) after the informed consent are randomized to: auto-HSCT vs no auto-HSCT, - with the similar further maintenance. Stem cell harvest is performed after the 3rd consolidation by G-SCF disregarding minimal residual disease (MRD) level. Auto-HSCT is planned after the 5th consolidation phase. All primary bone samples are collected and tested for cytogenetics and molecular markers, all included patients are monitored by flow cytometry by aberrant immunophenotype in a centralized lab.', 'detailedDescription': '* 7 days prednisolone prephase\n* 8 weeks induction with de-escalation of induction chemotherapy: 3 instead of 4 dauno/vncr pulses,\n\n 1. instead of 2 Cph injections during induction,\n 2. instead of 4 ARA-C blocks, distribution of of L-asp injections through all phases\n* After CR achievement T-cell ALL patients are being randomized to auto-HSCT vs no auto-HSCT\n* Non-interruptive 5 consolidation phases with dose modification according to WBC and platelets count after CR achievement. Rotation of consolidation is permitted\n* After the 3rd consolidation stem cells harvesting is carried out for T-cell ALL patients randomized to auto-HSCT\n* Auto-HSCT after the 5th consolidation phase with non-myeloablative CEAM conditioning\n* 2 years maintenance for all patients\n* 21 TIT through the whole treatment with higher intensity during induction\\|consolidation\n* Centralized MRD monitoring at +70 d, + 133 d, + 190 days; before and after auto-HSCT\n* Allo-HSCT is planned only for very high risk patients (11q23 ALL, MRD positivity at day +190)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-55 yy, newly diagnosed non-treated Ph-negative ALL\n\nExclusion Criteria:\n\n* age \\> 55 yy, Ph-positivity, relapsed\\|refractory ALL, pretreated ALL'}, 'identificationModule': {'nctId': 'NCT03462095', 'briefTitle': 'De-escalated Treatment Approach for Adult Ph-negative Acute Lymphoblastic Leukemia (ALL)', 'organization': {'class': 'NETWORK', 'fullName': 'National Research Center for Hematology, Russia'}, 'officialTitle': 'Non-intensive But Non-interruptive Treatment of Adult Ph-negative Acute Lymphoblastic Leukemia With Randomization for Maintenance or Autologous Hematopoietic Stem Cell Transplantation (HSCT) Followed by Maintenance in T-cell ALL Patients', 'orgStudyIdInfo': {'id': 'ALL--2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'no Auto-HSCT', 'description': 'After completing prolonged consolidation T-cell ALL patients will continue with 2 years maintenance'}, {'type': 'EXPERIMENTAL', 'label': 'Auto-HSCT', 'description': 'After completing prolonged consolidation T-cell ALL patients will get autologous HSCT followed by 2 years maintenance', 'interventionNames': ['Procedure: Autologous HSCT']}], 'interventions': [{'name': 'Autologous HSCT', 'type': 'PROCEDURE', 'description': 'After the 3rd consolidation, T-cell ALL patients, randomized to auto-HSCT will be mobilised by G-SCF and harvested disregarding MRD-status. After completing the 5th consolidation T-ALL patients will be transplanted after non-myeloablative CEAM (CCNU, Ethoposide, ARA-C, Melphalan) conditioning, and after reconstitution will continue 2-years maintenance', 'armGroupLabels': ['Auto-HSCT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '125167', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Elena N Parovichnikova, MD PhD', 'role': 'CONTACT', 'email': 'elenap@blood.ru', 'phone': '+7(495)6124313'}], 'facility': 'National Research Center for Hematology', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Elena N Parovichnikova, MD,PhD', 'role': 'CONTACT', 'email': 'elenap@blood.ru', 'phone': '+79161252623'}, {'name': 'Olga A Gavrilina, M.D.', 'role': 'CONTACT', 'email': 'dr.gavrilina@mail.ru'}], 'overallOfficials': [{'name': 'Valeriy V Savchenko, Academician', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Research Center for hematology, Moscow, Russia'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Once a year', 'ipdSharing': 'YES', 'description': 'Each participating site has its on-line access to WEB-data base', 'accessCriteria': 'phone-call to coodinating center'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Research Center for Hematology, Russia', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}