A Retrospective and Prospective Observational Study of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Treatment and Ibrutinib Treatment of CLL/SLL in Routine Clinical Practice
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Lymphocytic Leukemia
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Enrollment
- 580
- Locations
- 1
- Primary Endpoint
- Patient and disease characteristics
- Last Updated
- 6 years ago
Overview
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 ibrutinib-treated CLL patients in China. This study will include both retrospective and prospective data collection.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Patient and disease characteristics
Time Frame: Up to 10 years
age, gender, Eastern Cooperative Oncology Group (ECOG), stage, Bulky disease, Cytogenetics, median ANC, median hemoglobin, median platelets, comorbidity.
Treatment pattern
Time Frame: Baseline
number of prior therapies, every treatment regimen, dose, cycle/treatment duration, stem cell therapy (SCT), progression-free survival (PFS), overall survival (OS), patient-reported outcome.
Secondary Outcomes
- Treatment response(Up to 10 years)