Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT03987958
Status:
RECRUITING
Last Update Posted:
2025-01-10
First Post:
2019-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Describe the Safety and Effectiveness of Venetoclax in Acute Myeloid Leukemia (AML) Patients (REVIVE Study)
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-08', 'studyFirstSubmitDate': '2019-06-14', 'studyFirstSubmitQcDate': '2019-06-14', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Time from treatment to death from any cause, up to approximately 30 months', 'description': 'Overall survival is defined as the time from the date of first treatment to the date of death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Percentage of participants achieving composite complete remission (CR or CRi)', 'timeFrame': 'Approximately 30 months', 'description': 'The percentage of participants achieving CR or CRi will be calculated based on the modified International Working Group (IWG) criteria for AML.'}, {'measure': 'Time to transfusion independence', 'timeFrame': 'Up to 30 months', 'description': 'Transfusion independence is defined as the time between date of first venetoclax treatment and absence of red blood cell (RBC) or platelet transfusion for any consecutive 8 and/or 16 week period.'}, {'measure': 'Change in patient reported outcomes for the Euro Quality of Life 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L)', 'timeFrame': 'Week 0 to approximately 30 months', 'description': 'The EQ-5D-5L is a standardized, non-disease specific instrument used to measure health-related quality of life. The EQ-5D-5L assesses general health on 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The scores for the 5 dimensions are used to compute a single utility index score ranging from 0 to 1 representing the general health status of the individual, with higher scores indicating better health state.'}, {'measure': 'Percentage of participants treated with venetoclax as compared to participants treated with other approved biologics', 'timeFrame': 'Up to approximately 30 months', 'description': 'The percentage of participants treated with venetoclax in combination with Hypomethylating Agents (HMAs) and Low Dose Cytarabine (LDAC) will demonstrate treatment patterns of prescribing physicians.'}, {'measure': 'Change in patient reported outcomes for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire CORE (EORTC QLQ-C30)', 'timeFrame': 'Week 0 to approximately 30 months', 'description': 'EORTC QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).'}, {'measure': 'Percentage of participants achieving transfusion independence', 'timeFrame': 'Up to 30 months', 'description': 'Transfusion independence is defined as the time between date of first venetoclax treatment and absence of red blood cell (RBC) or platelet transfusion for any consecutive 8 and/or 16 week period.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Myeloid Leukemia, Venetoclax'], 'conditions': ['Acute Myeloid Leukemia']}, 'referencesModule': {'references': [{'pmid': '39637307', 'type': 'DERIVED', 'citation': 'Wolach O, Levi I, Nachmias B, Tavor S, Amitai I, Ofran Y, Ganzel C, Zuckerman T, Okasha D, Hellmann I, Tadmor T, Dally N, Canaani J, Stemer G, Grunspan M, Berger AJ, Frankel N, Berelovich J, Bleterman A, Barak M, Cohen R, Moshe Y. Trial eligibility, treatment patterns, and outcome for venetoclax-based therapy in AML: a prospective cohort study. Blood Adv. 2025 Apr 8;9(7):1544-1554. doi: 10.1182/bloodadvances.2024014014.'}], 'seeAlsoLinks': [{'url': 'https://www.rxabbvie.com/', 'label': 'Related info'}]}, 'descriptionModule': {'briefSummary': 'This study will describe the safety and effectiveness of venetoclax in AML patients in routine clinical practice in Israel. The decision to treat with venetoclax is made by the physician prior to any decision regarding participation in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with AML treated with venetoclax in routine clinical practice', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant diagnosed with Acute Myeloid Leukemia (AML) and is eligible to receive venetoclax per Israel Ministry of Health.\n* Participant who will be treated with venetoclax and the decision to treat with venetoclax is made by the physician prior to any decision regarding participation in this study.\n\nExclusion Criteria:\n\n\\- Participant participating in an interventional trial within 30 days prior to starting venetoclax treatment.'}, 'identificationModule': {'nctId': 'NCT03987958', 'acronym': 'REVIVE', 'briefTitle': 'A Study to Describe the Safety and Effectiveness of Venetoclax in Acute Myeloid Leukemia (AML) Patients (REVIVE Study)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Prospective Non-interventional Study to Describe the Effectiveness and Safety of Venetoclax in Acute Myeloid Leukemia (AML) Patients in Routine Clinical Practice (REVIVE Study)', 'orgStudyIdInfo': {'id': 'P19-831'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Venetoclax', 'description': 'Participants in this observational study will receive treatment with venetoclax for AML.\n\nThe decision to treat with venetoclax has been made independently from this observational study before participants are offered the opportunity to participate in this study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4428164', 'city': 'Kfar Saba', 'state': 'Central District', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'Meir Medical Center /ID# 213352', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'zip': '6971028', 'city': 'Tel Aviv', 'state': 'Central District', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Israel', 'facility': 'Assuta Tel Aviv Medical Center /ID# 213371'}, {'zip': '1834111', 'city': 'Afula', 'state': 'H_efa', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Israel', 'facility': 'HaEmek Medical Center /ID# 213370', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}, {'zip': '3109601', 'city': 'Haifa', 'state': 'H_efa', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Israel', 'facility': 'Rambam Health Care Campus /ID# 213355', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '3339419', 'city': 'Haifa', 'state': 'H_efa', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Israel', 'facility': 'Bnai Zion Medical Center /ID# 213344', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '91031', 'city': 'Jerusalem', 'state': 'Jerusalem', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Israel', 'facility': 'Shaare Zedek Medical Center /ID# 228016', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '91120', 'city': 'Jerusalem', 'state': 'Jerusalem', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Israel', 'facility': 'Hadassah /ID# 213356', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '13100', 'city': 'Safed', 'state': 'Northern District', 'status': 'COMPLETED', 'country': 'Israel', 'facility': 'ZIV Medical Center /ID# 229211', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}, {'zip': '8443901', 'city': 'Beersheba', 'state': 'Southern District', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Israel', 'facility': 'Soroka University Medical Center /ID# 213369', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '5265601', 'city': 'Ramat Gan', 'state': 'Tel Aviv', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Israel', 'facility': 'The Chaim Sheba Medical Center /ID# 213353', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '6423906', 'city': 'Tel Aviv', 'state': 'Tel Aviv', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Israel', 'facility': 'Tel Aviv Sourasky Medical Center /ID# 213354', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '4941492', 'city': 'Haifa', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Israel', 'facility': 'Rabin Medical Center /ID# 213343', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Jenia Berelovich', 'role': 'CONTACT', 'email': 'jenia.berelovich@abbvie.com', 'phone': '972528298196'}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}