Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-04 @ 1:46 AM
Study NCT ID:
NCT06557304
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-21
First Post:
2024-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Real World Study of BTK Inhibitor in the Treatment of Chronic Lymphocytic Leukemia in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2024-08-13', 'studyFirstSubmitQcDate': '2024-08-13', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'up to five years', 'description': 'OS is defined as the time from the starting date of BTK inhibitor to the date of death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'Time to Next Therapy (TTNT)', 'timeFrame': 'up to two years', 'description': 'The TTNT will be calculated as the difference between BTK inhibitor initiation date and initiation date of the first next therapy for CLL'}, {'measure': 'Adverse Events', 'timeFrame': 'up to five years', 'description': 'Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CLL']}, 'descriptionModule': {'briefSummary': 'This is a Multicenter, Retrospective Real-world Study of Zanubrutinib in the Treatment of Chronic Lymphocytic Leukemia in China'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Investigators participating in this observational study should include all patients with CLL who initiated treatment with BTK inhibitor over the period from Dec. 1st, 2017 to the present, regardless of the treatment status at the time of inclusion. Thus, at the time of enrolment and retrospective data collection, patients may still be on treatment or have stopped treatment for any reason.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged ≥18 years old\n2. Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) requiring treatment (iwCLL \\[International Workshop on Chronic Lymphocytic Leukemia\\] criteria)；\n3. Treatment-naïve OR Refractory Recurrence CLL patients who were initiated on BTK inhibitor;\n4. Prior or current use of BTK inhibitor for ≥3 months\n5. At least one follow-up was recorded during BTK inhibitor treatment'}, 'identificationModule': {'nctId': 'NCT06557304', 'briefTitle': 'The Real World Study of BTK Inhibitor in the Treatment of Chronic Lymphocytic Leukemia in China', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'This is a Multicenter, Retrospective Real-world Study of BTK Inhibitor in the Treatment of Chronic Lymphocytic Leukemia in China', 'orgStudyIdInfo': {'id': 'BTKi-CLL-RWE'}}, 'armsInterventionsModule': {'interventions': [{'name': 'BTK inhibitor', 'type': 'DRUG', 'description': 'patients with treatment naive or R/R CLL who treatment with BTK inhibitor'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Shengmiao Yang, MD', 'role': 'CONTACT', 'email': 'yangshenmiao@hotmail.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Xiao-Jun Huang', 'investigatorAffiliation': "Peking University People's Hospital"}}}}