Status:
UNKNOWN
Observational Study of CLL/SLL Treatment and Ibrutinib Treatment of CLL/SLL in Routine Clinical Practice
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Collaborating Sponsors:
Xian-Janssen Pharmaceutical Ltd.
Conditions:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Brief Summary
This is a non-interventional, Phase 4 study designed to improve understanding of current clinical practice in the treatment of CLL/SLL and to describe treatment pattern and evaluate outcomes of ibruti...
Eligibility Criteria
Inclusion
- In the retrospective part:
- Male or female patients above 18 years old
- Patients underwent CLL treatment after Jan 1st, 2013
- Patient understand and voluntarily sign an ICF, if applicable.
- In the prospective part:
- Male or female patients above 18 years old
- Patients diagnosed with CLL，including treatment- naïve patients or patients who have received ≤3 prior therapies
- Patients treated with ibrutinib as monotherapy or a part of combination therapy
- Patient understand and voluntarily sign an ICF.
Exclusion
- In the retrospective part:
- Patients with documented diagnosis of other cancers prior to the diagnosis of CLL
- Patients enrolled in interventional clinical trials of any drug for CLL treatment
- In the prospective part:
- Patients with documented diagnosis of other cancers prior to the diagnosis of CLL
- Patients with contraindication listed in the package insert of ibrutinib
- Patients enrolled in interventional clinical trials of ibrutinib or any other drug for CLL treatment
- Patient received Ibrutinib treatment as maintenance therapy.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
580 Patients enrolled
Trial Details
Trial ID
NCT04094051
Start Date
October 1 2019
End Date
December 31 2021
Last Update
September 18 2019
Active Locations (1)
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1
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210000