Clinical trial · Observational
A Study of Obinutuzumab Evaluating Efficacy, Safety and Cost of Disease Management in Participants With Chronic Lymphocytic Leukemia and Comorbidities
A Multicenter, Single Arm, Non-Interventional, Observational Study of Obinutuzumab to Evaluate Efficacy, Safety and Cost of Disease Management in Patients With Chronic Lymphocytic Leukemia and Comorbidities in Greece
- 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 multicenter, single arm, non-interventional, observational study will evaluate the efficacy and safety of obinutuzumab in daily clinical practice in participants with chronic lymphocytic leukemia (CLL). The study will also assess cost of disease management. The total length of the study is 42 months.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chlorambucil | Drug | Chlorambucil | ALIAS |
| Obinutuzumab | Drug | Obinutuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Obinutuzumab
- description
- Participants will receive obinutuzumab as per Summary of Product Characteristics in daily practice along with chlorambucil for 24 months.
- interventionNames
- Drug: Chlorambucil
- Drug: Obinutuzumab
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)\n
- timeFrame
- From screening every 6 months to Month 18 until disease progression (up to 24 months)
Secondary outcomes (16)
- measure
- Overall Survival (OS)
- timeFrame
- From screening every 6 months to Month 18 until disease progression (up to 24 months)
- measure
- Percentage of Participants With Overall Response as Assessed by Investigator
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants with untreated CLL and comorbidities, for which the physician has already decided to use obinutuzumab in association with chlorambucil Exclusion Criteria: * Participation in another clinical trial during the study
References
Publications (0)
Data not yet available