Clinical trial · Observational
A Real-world Study of Ibrutinib and Venetoclax (I+V) First-Line Treatment Given for Fixed-duration of Time in Participants With Chronic Lymphocytic Leukemia
Prospective Cohort Study With Fixed-Duration Ibrutinib + Venetoclax (I+V) First-Line Treatment in Patients With Chronic Lymphocytic Leukemia in a Real-World Setting
NCT07602088CI-TRIAL-00124381REALITY-ROrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
The purpose of this study is to see how well Ibrutinib and Venetoclax (I+V) treatment works (effectiveness) for participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) when it is used in routine, everyday medical care.
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 |
|---|---|---|---|
| Leukemia, Lymphocytic, Chronic, B-Cell | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Participants
- description
- Participants with a confirmed diagnosis of CLL/SLL requiring first-line treatment, per international workshop on chronic lymphocytic leukemia (iwCLL) 2018 or at the discretion of the treating physician using ibrutinib plus venetoclax treatment in routine clinical practice will be enrolled in this study. No drug will be administered and only data available within routine clinical practice will be collected in this study.
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- Up to approximately Week 60
- description
- The ORR is defined as the percentage of participants achieving the best response of complete or partial response (including complete response \[CR\], complete response with incomplete hematological recovery \[CRi\], partial response \[PR\] or partial response with lymphocytosis \[PR-L\]).
Secondary outcomes (15)
- measure
- Number of Participants with Factors Affecting the Physician Treatment Decision Using the Physician's Treatment Decision Questionnaire
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) requiring treatment according to international workshop on chronic lymphocytic leukemia (iwCLL) 2018 guidelines * Intented for the treatment with fixed-duration ibrutinib plus venetoclax treatment (I+V) according to the approved indication. Decision to start I+V treatment must have been taken before and independently of participant's inclusion in the study * Participant must sign an informed consent form (ICF) allowing source data verification in accordance with local requirements * Is able to read, understand, and complete the PRO instruments in local language and comply with completion of all patient-reported outcome (PRO) instruments Exclusion Criteria * Has a history of CLL/SLL treatment * Has received an investigational medicinal product (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study or the first data collection time point * Is currently enrolled or plans to participate in an interventional clinical study (participation in a non-Janssen sponsored non-interventional study or registry is allowed) * Falls under any restrictions or limitations preventing treatment with I+V as per the current approved label of ibrutinib or venetoclax in Romania
References
Publications (0)
Data not yet available
No reference posted for this study.