Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2025-12-27 @ 9:34 PM
Study NCT ID:
NCT04655261
Status:
TERMINATED
Last Update Posted:
2022-10-26
First Post:
2020-11-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Oral Venetoclax Tablets in Combination With Intravenous Obinutuzumab Injection to Assess Achievement of Best Response in Adult Participants With Chronic Lymphocytic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Lack of Recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-24', 'studyFirstSubmitDate': '2020-11-30', 'studyFirstSubmitQcDate': '2020-11-30', 'lastUpdatePostDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Overall Response Rate (ORR) Best Response', 'timeFrame': 'Up to approximately 36 Months', 'description': 'ORR is defined as complete remission (CR) + complete remission with incomplete bone marrow recovery (CRi) + partial remission (PR) + nodular partial remission (nPR).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Objective Response Rate (ORR)', 'timeFrame': 'Up to 12 Months', 'description': 'ORR is defined as CR + CRi + PR + nPR.'}, {'measure': 'Time to First Response', 'timeFrame': 'Up to approximately 36 Months', 'description': 'Time to first response is defined as number of days from first venetoclax intake to first response.'}, {'measure': 'Time to Best Response', 'timeFrame': 'Up to approximately 36 Months', 'description': 'Time to best response is defined as number of days from first venetoclax intake to best response (CR, CRi, PR, nPR).'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'Up to approximately 36 Months', 'description': 'Duration of Response (DoR) is defined as number of days from first response to disease progression or death from any cause, whichever comes first.'}, {'measure': 'Time to Next Treatment', 'timeFrame': 'Up to approximately 36 Months', 'description': 'Time to next treatment is defined as number of days from first venetoclax intake to first intake of next treatment including death from any cause.'}, {'measure': 'Minimal Residual Disease (MRD)', 'timeFrame': 'Up to 36 Months', 'description': 'Percentage of participants achieving MRD (CLL \\< 10000 leucocytes) in the bone marrow, peripheral blood, either and both will be assessed.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 36 Months', 'description': 'OS is defined as the number of days from the date of first dose to the date of the observational period end or death for all dosed participants.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Up to 36 Months', 'description': 'PFS is defined as the interval (in days) between the first treatment day to the first sign of disease progression or death from any cause.'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to approximately 36 Months', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Lymphocytic Leukemia (CLL)', 'Venetoclax', 'Venclexta', 'Obinutuzumab', 'Cancer'], 'conditions': ['Chronic Lymphocytic Leukemia (CLL)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=P20-486&Latitude=&Longitude=&LocationName=#additional-resources-section', 'label': 'clinical study report synopsis'}]}, 'descriptionModule': {'briefSummary': 'Chronic Lymphoid Leukemia (CLL) is the most common type of leukemia (cancer of blood cells) in adults affecting men more so than women. The main objective of this study is to assess the how effective venetoclax (Venclexta) in combination with Obinutuzumab is in treating Chronic Lymphocytic Leukemia (CLL). Effectiveness is assessed by achievement of best response.\n\nVenetoclax is an approved drug developed for the treatment of CLL. Approximately 50 adult participants with previously untreated CLL will be enrolled in approximately 10 to 15 sites in Russian Federation.\n\nParticipants will receive oral venetoclax tablets in combination with intravenous (IV) Obinutuzumab as prescribed by the physician prior to enrolling in this study in accordance to the local practice and label.\n\nThere may be a higher burden for participants in this study compared to standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult participants with previously untreated chronic lymphocytic leukemia (CLL)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of previously untreated Chronic Lymphocytic Leukemia (CLL).\n* Participant for whom the physician has decided to initiate CLL treatment with Venetoclax combo therapy with Obinutuzumab, according to approved local label up to 4 weeks (28 days) after Obinutuzumab treatment initiation.\n\nExclusion Criteria:\n\n* Contraindications to Venclexta (Venetoclax) as listed on the approved local label in Russian Federation.\n* Creatinine Clearance \\< 30 milliLitres/minute.\n* Richter syndrome or Transformation of CLL to aggressive non-Hodgkin lymphoma.\n* Participating in a clinical trial with an investigative drug for CLL.'}, 'identificationModule': {'nctId': 'NCT04655261', 'acronym': 'FIRST', 'briefTitle': 'Study of Oral Venetoclax Tablets in Combination With Intravenous Obinutuzumab Injection to Assess Achievement of Best Response in Adult Participants With Chronic Lymphocytic Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Prospective Multi-Center Observational Study to Assess Effectiveness of Venclexta (Venetoclax) in Combination With Obinutuzumab in Population of Previously Untreated Chronic Lymphocytic Leukemia Patients in Routine Clinical Practice in Russian Federation (FIRST)', 'orgStudyIdInfo': {'id': 'P20-486'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants Treated With Venetoclax + Obinutuzumab', 'description': 'Participants will receive venetoclax (Venclexta) in combination with Obinutuzumab according to local label.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '125284', 'city': 'Moscow', 'state': 'Moscow', 'country': 'Russia', 'facility': 'Moscow State budget healthcare /ID# 226058', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '400138', 'city': 'Volgograd', 'state': 'Volgograd Oblast', 'country': 'Russia', 'facility': "Regional Children's Clinical Hospital of Volgograd /ID# 238328", 'geoPoint': {'lat': 48.71378, 'lon': 44.4976}}, {'zip': '191024', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 231127', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '300053', 'city': 'Tula', 'country': 'Russia', 'facility': 'Tula Regional Clinical Hospital /ID# 231128', 'geoPoint': {'lat': 54.19609, 'lon': 37.61822}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}