Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-01-01 @ 3:26 AM
Study NCT ID:
NCT03902769
Status:
UNKNOWN
Last Update Posted:
2019-04-08
First Post:
2019-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess Length of Remission With Intensive Chemotherapy in Rapidly Responding AML Patients.
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'One arm open study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-04-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-04', 'studyFirstSubmitDate': '2019-04-02', 'studyFirstSubmitQcDate': '2019-04-02', 'lastUpdatePostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event free survival', 'timeFrame': 'Two years'}], 'secondaryOutcomes': [{'measure': 'Overall survivial', 'timeFrame': 'two years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'We previously reported results of a prospective observational study demonstrating that early response defined as reduction in bone marrow (BM) blast counts to less than 5% of BM cells by the fifth day of induction therapy is a strong predictor of remission and overall survival (Ofran Y, et al. AJH, 2015). The long term survival benefit of early response was confirmed later on after a median follow-up for surviving patients of 53 months (range 17.5-84.5).', 'detailedDescription': 'Patients diagnosed with AML, younger than 61 year of age assigned for intensive chemotherapy, and diagnosed with standard or intermediate risk AML, will undergo BM examination on the fifth day of induction. Patients in whom BM blast count at the fifth day of induction will be lower than 5% will proceed therapy with consolidations or autologous SCT with-holding the option for allo-SCT. MRD monitoring will apply to those with reliable molecular marker.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '61 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AML diagnosis,\n* treated with 3+7 Induction chemotherapy\n* Intermediate/standard risk AML\n\nExclusion Criteria:\n\n* Diagnosed of APL\n* high risk molecular/cytogenetic score'}, 'identificationModule': {'nctId': 'NCT03902769', 'acronym': 'AML', 'briefTitle': 'Study to Assess Length of Remission With Intensive Chemotherapy in Rapidly Responding AML Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Phase II Prospective Study to Assess Rate for Prolonged Remission With Intensive Chemotherapy in Rapid Respondents AML Patients Younger Than 61 as Demonstrated by Day 5 Examination of the First Treatment.', 'orgStudyIdInfo': {'id': 'RMB-250-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'No allogeneic SCT', 'description': 'For standard or intermediate risk AML patients who achieved good rapid response, allogenic SCT will be excluded from treatment plan', 'interventionNames': ['Procedure: Prescribing conventional chemotherapy while with holding allo-SCT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard post induction therapy', 'description': 'For slow responding AML patients, post induction therapy will be provided according to treating physician discretion', 'interventionNames': ['Procedure: Prescribing conventional chemotherapy while with holding allo-SCT']}], 'interventions': [{'name': 'Prescribing conventional chemotherapy while with holding allo-SCT', 'type': 'PROCEDURE', 'otherNames': ['No Allogeneic for rapid responders'], 'description': 'Prescribing conventional chemotherapy (chemotherapy consolidations or autologous SCT) while with holding allo-SCT', 'armGroupLabels': ['No allogeneic SCT', 'Standard post induction therapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yishai Ofran, MD', 'role': 'CONTACT', 'email': 'y_ofran@rambam.health.gov.il', 'phone': '+972-4-7778026'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of leukemia Service', 'investigatorFullName': 'Dr. Yishai Ofran', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}