Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Conditions
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.
Interventions
DRUGIbrutinib
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.
Sponsors
Xian-Janssen Pharmaceutical Ltd.
The First Affiliated Hospital with Nanjing Medical University
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* In the retrospective part: 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
* In the retrospective part: 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient and disease characteristics | Up to 10 years | age, gender, Eastern Cooperative Oncology Group (ECOG), stage, Bulky disease, Cytogenetics, median ANC, median hemoglobin, median platelets, comorbidity. |
| Treatment pattern | 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
| Measure | Time frame | Description |
|---|---|---|
| Treatment response | Up to 10 years | PFS, ORR, OS, minimal residual disease(MRD), patient-reported outcomes |
Countries
China
Contacts
Primary ContactJianyong Li, Ph.D.
Outcome results
None listed