Clinical trial · Observational
Observational Study of CLL/SLL Treatment and Ibrutinib Treatment of CLL/SLL in Routine Clinical Practice
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ibrutinib | Drug | Ibrutinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Patient and disease characteristics
- timeFrame
- Up to 10 years
- description
- age, gender, Eastern Cooperative Oncology Group (ECOG), stage, Bulky disease, Cytogenetics, median ANC, median hemoglobin, median platelets, comorbidity.
- measure
- Treatment pattern
- timeFrame
- Baseline
- description
- 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 (1)
- measure
- Treatment response
- timeFrame
- Up to 10 years
- description
- PFS, ORR, OS, minimal residual disease(MRD), patient-reported outcomes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available