Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-29 @ 1:44 PM
Study NCT ID:
NCT03873857
Status:
COMPLETED
Last Update Posted:
2023-09-01
First Post:
2019-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess Effectiveness of Venclexta (Venetoclax) in Patients With Relapse or Refractory Chronic Lymphocytic Leukemia in Routine Clinical Practice in Russian Federation
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C579720', 'term': 'venetoclax'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-30', 'studyFirstSubmitDate': '2019-03-12', 'studyFirstSubmitQcDate': '2019-03-12', 'lastUpdatePostDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) 12 Months after Treatment Initiation', 'timeFrame': 'Up to approximately 12 months after treatment initiation', 'description': 'ORR is defined as the percentage of participants who reach either complete remission (CR), CR with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) to treatment.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) 24 Months after Treatment Initiation', 'timeFrame': 'Up to approximately 24 months after treatment initiation', 'description': 'ORR is defined as the percentage of participants who reach either complete remission (CR), CR with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) to treatment.'}, {'measure': 'Time to First Response to Treatment', 'timeFrame': 'Up to approximately 24 months', 'description': 'The time to response to treatment is defined by the time between the date of the first venetoclax intake and the date of the first assessment having documented a response (CR, CRi, nPR, and PR).'}, {'measure': 'Time to Best Response to Treatment', 'timeFrame': 'Up to approximately 24 months', 'description': 'The time to best response to treatment is defined by the time between the date of the first venetoclax intake and the date of the best response documented (CR, CRi, nPR, and PR).'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'Up to approximately 24 months', 'description': 'DoR defined as the number of days from the date of first response (CR, CRi, nPR, or PR) to the date of disease progression or death from any cause, whichever comes first.'}, {'measure': 'Time To Next Treatment', 'timeFrame': 'Up to approximately 24 months', 'description': 'The time to next treatment is defined as the time between the date of the first venetoclax intake and the date of the first next treatment intake after venetoclax discontinuation.'}, {'measure': 'Percentage of Patients with Undetectable Minimal Residual Disease (MRD)', 'timeFrame': 'Up to approximately 24 months', 'description': 'Patients will be defined as having a clinical remission in the absence of MRD when they have blood or marrow with less than one CLL cell per 10000 leucocytes.'}, {'measure': 'Overall Survival (OS) Rate', 'timeFrame': 'Up to approximately 24 months', 'description': 'OS is defined as number of days from the date of first dose to the date of the observational period end or death for all dosed patients.'}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Up to approximately 24 months', 'description': 'Progression-free survival is defined as the interval between the first treatment day to the first sign of disease progression or death from any cause'}, {'measure': 'Change from Baseline in RAND Short Form (SF)-36 Questionnaire', 'timeFrame': 'Up to approximately 24 months', 'description': 'Patient quality of life was measured by the RAND-36 health-related quality of life (HRQoL) survey instrument. This questionnaire is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Lymphocytic Leukemia (CLL)', 'Cancer', 'Observational Study', 'Venetoclax', 'Relapsed Chronic Lymphocytic Leukemia', 'Refractory Chronic Lymphocytic Leukemia'], 'conditions': ['Chronic Lymphocytic Leukemia (CLL)', 'Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=P19-569#additional-resources-section', 'label': 'clinical study report synopsis'}]}, 'descriptionModule': {'briefSummary': 'This study seeks to assess the effectiveness and safety of venetoclax in patients with relapsed and refractory chronic lymphocytic leukemia (CLL) in a real-world setting across clinical practice in the Russian Federation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with relapsed or refractory CLL in a real-world clinical practice setting.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has a confirmed diagnosis of relapsed or refractory CLL.\n* Patient for whom the physician has decided to initiate CLL treatment with venetoclax (mono and combo therapy), or up to 4 weeks after venetoclax treatment initiation\n* Patient voluntarily agrees to participate in this study and signs informed consent form\n\nExclusion Criteria:\n\n* Has contraindications to venetoclax as listed on the approved local label in Russian Federation.\n* Has Richter syndrome\n* Participated in a clinical trial with an investigative drug for CLL within 30 days prior to treatment initiation'}, 'identificationModule': {'nctId': 'NCT03873857', 'acronym': 'FORTE', 'briefTitle': 'A Study to Assess Effectiveness of Venclexta (Venetoclax) in Patients With Relapse or Refractory Chronic Lymphocytic Leukemia in Routine Clinical Practice in Russian Federation', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Prospective Multi-Center Observational Study to Assess Effectiveness of Venclexta (Venetoclax) in Population of Relapse or Refractory Chronic Lymphocytic Leukemia Patients in Routine Clinical Practice in Russian Federation (FORTE)', 'orgStudyIdInfo': {'id': 'P19-569'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Venetoclax', 'description': 'Participants in this observational study will receive treatment with venetoclax for up to 24 months for treatment of relapsed or refractory CLL.\n\nThe prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study.', 'interventionNames': ['Drug: Venetoclax']}], 'interventions': [{'name': 'Venetoclax', 'type': 'DRUG', 'otherNames': ['Venclexta', 'ABT-199'], 'description': 'tablet;oral', 'armGroupLabels': ['Venetoclax']}]}, 'contactsLocationsModule': {'locations': [{'zip': '354057', 'city': 'Sochi', 'state': 'Krasnodarskiy Kray', 'country': 'Russia', 'facility': 'Oncology Dispensary #2 /ID# 215831', 'geoPoint': {'lat': 43.59699, 'lon': 39.72477}}, {'zip': '125284', 'city': 'Moscow', 'state': 'Moscow', 'country': 'Russia', 'facility': 'Moscow State budget healthcare /ID# 212875', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '129110', 'city': 'Moscow', 'state': 'Moscow Oblast', 'country': 'Russia', 'facility': 'Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 215830'}, {'zip': '197101', 'city': 'Saint Petersburg', 'state': 'Sankt-Peterburg', 'country': 'Russia', 'facility': 'Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 212368', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '620137', 'city': 'Yekaterinburg', 'state': 'Sverdlovsk Oblast', 'country': 'Russia', 'facility': 'Central City Hospital #7 /ID# 212373', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}, {'zip': '400138', 'city': 'Volgograd', 'state': 'Volgograd Oblast', 'country': 'Russia', 'facility': "Regional Children's Clinical Hospital of Volgograd /ID# 212366", 'geoPoint': {'lat': 48.71378, 'lon': 44.4976}}, {'zip': '656024', 'city': 'Barnaul', 'country': 'Russia', 'facility': 'Krai Clinical Hospital /ID# 224952', 'geoPoint': {'lat': 53.36199, 'lon': 83.72786}}, {'zip': '664032', 'city': 'Irkutsk', 'country': 'Russia', 'facility': 'GBUZ Regional Cancer center /ID# 216871', 'geoPoint': {'lat': 52.29566, 'lon': 104.29076}}, {'zip': '680009', 'city': 'Khabarovsk', 'country': 'Russia', 'facility': 'Krai Clinical Hospital #1 /ID# 212367', 'geoPoint': {'lat': 48.46204, 'lon': 135.0971}}, {'zip': '610027', 'city': 'Kirov', 'country': 'Russia', 'facility': 'Kirov Regional Clinical Hospital /ID# 217579', 'geoPoint': {'lat': 58.59809, 'lon': 49.65783}}, {'zip': '302040', 'city': 'Oryol', 'country': 'Russia', 'facility': 'Policlinic #2 /ID# 214778', 'geoPoint': {'lat': 52.96879, 'lon': 36.0791}}, {'zip': '614077', 'city': 'Perm', 'country': 'Russia', 'facility': 'Clinical Medico-Sanitary Unit #1 /ID# 212364', 'geoPoint': {'lat': 58.01046, 'lon': 56.25017}}, {'zip': '191024', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 212372', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197341', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Almazov National Medical Research Centre /ID# 212365', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '167904', 'city': 'Syktyvkar', 'country': 'Russia', 'facility': 'Komi Republican Oncology Dispensary /ID# 212370', 'geoPoint': {'lat': 61.66393, 'lon': 50.8163}}, {'zip': '600031', 'city': 'Vladimir', 'country': 'Russia', 'facility': 'City Clinical Hospital # 5 /ID# 212369', 'geoPoint': {'lat': 56.13854, 'lon': 40.39976}}, {'zip': '160002', 'city': 'Vologda', 'country': 'Russia', 'facility': 'Regional Clinical Hospital of Vologda /ID# 212471', 'geoPoint': {'lat': 59.2239, 'lon': 39.88398}}, {'zip': '677008', 'city': 'Yakutsk', 'country': 'Russia', 'facility': 'Republican Hospital #1 - National Center of Medicine of Sakha (Yakutia) /ID# 212371', 'geoPoint': {'lat': 62.03114, 'lon': 129.72288}}, {'zip': '620102', 'city': 'Yekaterinburg', 'country': 'Russia', 'facility': 'Sverdlovsk Regional Clinical Hospital #1 /ID# 214777', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}, {'zip': '693004', 'city': 'Yuzhno-Sakhalinsk', 'country': 'Russia', 'facility': 'Sakhalin Regional Clinical Hospital /ID# 222503', 'geoPoint': {'lat': 46.9543, 'lon': 142.73559}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}