Clinical trial · Observational
Real-World Data Study Focused on Chronic Lymphocytic Leukemia (CLL) Patient Treatment Options and Their Effectiveness
A Czech Pharmaco-epidemiological Real-World Data Study Focused on CLL Patient Treatment Options and Their Effectiveness
- 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 study will be a secondary use of data, focusing on patients treated with combination therapy Obi-Clb, R-Clb or R-B, in a non-interventional, open label, national, multicenter setting. Retrospective analysis of data coming from registry database CLLEAR (www.leukemia-cell.org )that capture data on clinical and treatment practices in CLL. Data will be retrospectively analyzed.
Conditions
Conditions (1)
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 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- R-Clb patients
- description
- Patients treated with the combination of Rituximab + chlorambucil
- label
- R-B patients
- description
- Patients treated with the combination of Rituximab + bendamustine
- label
- Obi-Clb patients
- description
- Patients treated with the combination of Obinutuzumab + chlorambucil
Primary outcomes (5)
- measure
- Progression-free survival (PFS)
- timeFrame
- From the treatment administration until the disease progression, death or date of data export (up to 96 months)
- description
- PFS is defined as the number of months from the start of treatment with analyzed therapies (Obi-Clb, R-Clb, BR) until the first documentation of disease progression or death due to any cause, whichever occurred first. Kaplan-Meier method was used for evaluation.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of Chronic Lymphocytic Leukemia * Patients treated with Bendamustin plus Rituximab, Rituximab plus Chlorambucil or Obinutuzumab plus Chlorambucil regimens as first line of treatment * Provision of informed consent for recording of patient data in the CLLEAR registry Exclusion Criteria: * All untreated patients * Patients with both Rituximab plus Chlorambucil and Bendamustin plus Rituximab or Obinutuzumab plus Chlorambucil in second or subsequent lines * Patients with prednisone alongside analysed regimens in the first line of treatment * Patients with RCD (Rituximab, Cyclophosphamide, Dexamethasone) or FCR (Fludarabine, Cyclophosphamide, Rituximab) or other regimen before analysed regimens within the first line of treatment * Patients with R-Dex (Rituximab and Dexamethasone) cycles in between R-Clb cycles
References
Publications (0)
Data not yet available