Clinical trial · Observational
A Study to Describe the Effectiveness and Safety of Venetoclax Treatment in Chronic Lymphocytic Leukemia (CLL) Patients in Routine Clinical Practice
Post Marketing Observational Study to Describe the Effectiveness and Safety of Venetoclax Treatment in Chronic Lymphocytic Leukemia (CLL) Patients in Routine Clinical Practice
NCT03659669CI-TRIAL-00070655REVEALsuspendedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Strategic considerations
Summary
Brief summary (as posted)
This study will evaluate effectiveness and safety in routine clinical practice in participants starting venetoclax treatment for Chronic Lymphocytic Leukemia (CLL).
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 (CLL) | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Patients with Chronic Lymphocytic Leukemia (CLL)
- description
- Patients with diagnosed CLL and eligible to venetoclax as per label.
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- Up to approximately 12 months
- description
- ORR to treatment is defined as the proportion of patients with complete response (CR), Complete Response with incomplete bone marrow recovery (CRi), nodular Partial Response (nPR) and partial response (PR), according to physician's assessment.
Secondary outcomes (13)
- measure
- Overall Response Rate (ORR)
- timeFrame
- Up to approximately 24 months
- description
- ORR to treatment is defined as the proportion of patients with complete response (CR), Complete Response with incomplete bone marrow recovery (CRi), nodular Partial Response (nPR) or partial response (PR), according to physician's assessment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants with diagnosed Chronic Lymphocytic Leukemia (CLL) and eligible for venetoclax as per label. * Participants for whom the physician has decided to initiate CLL treatment with venetoclax. * Participants who have been informed verbally and in writing about this study, and who do not object to their data being processed or subjected to data quality control. Exclusion Criteria: \- Participants currently participating (or previously participated) in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.
References
Publications (0)
Data not yet available
No reference posted for this study.