Observational Study of CLL/SLL Treatment and Ibrutinib Treatment of CLL/SLL in Routine Clinical Practice
NCT ID: NCT04094051
Last Updated: 2019-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
580 participants
OBSERVATIONAL
2019-10-01
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Interventions
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Ibrutinib
In the retrospective period, clinical information of approximate 500 patients with CLL/SLL prior to the study initiation will be collected retrospectively through chart review. There will be one time follow-up to collect data on disease progression, survival status and patient-reported outcomes.
Eligibility Criteria
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Inclusion Criteria
1. Male or female patients above 18 years old
2. Patients underwent CLL treatment after Jan 1st, 2013
3. Patient understand and voluntarily sign an ICF, if applicable.
* In the prospective part:
1. Male or female patients above 18 years old
2. Patients diagnosed with CLL，including treatment- naïve patients or patients who have received ≤3 prior therapies
3. Patients treated with ibrutinib as monotherapy or a part of combination therapy
4. Patient understand and voluntarily sign an ICF.
Exclusion Criteria
1. Patients with documented diagnosis of other cancers prior to the diagnosis of CLL
2. Patients enrolled in interventional clinical trials of any drug for CLL treatment
* In the prospective part:
1. Patients with documented diagnosis of other cancers prior to the diagnosis of CLL
2. Patients with contraindication listed in the package insert of ibrutinib
3. Patients enrolled in interventional clinical trials of ibrutinib or any other drug for CLL treatment
4. Patient received Ibrutinib treatment as maintenance therapy.
18 Years
ALL
No
Sponsors
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Xian-Janssen Pharmaceutical Ltd.
INDUSTRY
The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Locations
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the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JNJ-54179060
Identifier Type: -
Identifier Source: org_study_id
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