Observational Study of CLL/SLL Treatment and Ibrutinib Treatment of CLL/SLL in Routine Clinical Practice

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Intervention / Treatment
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* Drug: Ibrutinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and disease characteristics | age, gender, Eastern Cooperative Oncology Group (ECOG), stage, Bulky disease, Cytogenetics, median ANC, median hemoglobin, median platelets, comorbidity. | Up to 10 years | 
| Treatment pattern | 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. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment response | PFS, ORR, OS, minimal residual disease(MRD), patient-reported outcomes | Up to 10 years |