Recruiting NCT07602088
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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Leukemia, Lymphocytic, Chronic, B-Cell. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Romania
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Cohort Study With Fixed-Duration Ibrutinib + Venetoclax (I+V) First-Line Treatment in Patients With Chronic Lymphocytic Leukemia in a Real-World Setting
Overview
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.
Primary outcome measures
- Overall Response Rate (ORR) [Time frame: Up to approximately Week 60]
Secondary outcome measures (12)
- Number of Participants with Factors Affecting the Physician Treatment Decision Using the Physician's Treatment Decision Questionnaire [Time frame: At baseline]
- Number of Participants with Factors Affecting Participant's Decision to Accept or Continue with the Proposed Treatment Using the Physician's Treatment Decision Questionnaire [Time frame: At baseline]
- Overall Response Rate (ORR) By the End of Treatment Cycles [Time frame: Up to approximately Week 48]
- Duration of response (DoR) [Time frame: Up to approximately Week 60]
- Progression-free survival (PFS) [Time frame: Up to approximately 4 years]
- Overall survival (OS) [Time frame: Up to approximately 4 years]
- Time on treatment (TOT) [Time frame: Up to approximately Week 60]
- Time to Treatment Discontinuation (TTD) [Time frame: Up to approximately Week 60]
- Time to Next Treatment (TTNT) [Time frame: Up to approximately Week 60]
- Change from Baseline in Health-Related Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chronic lymphocytic leukemia 17 (EORTC QLQ-CLL17) [Time frame: From Baseline up to approximately 4 years]
- Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations [Time frame: Up to approximately 4 years]
- Number of Participants with Tumor Lysis Risk [Time frame: At Baseline and After 12 Weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Romania · 1 center
- Spitalul Universitar de Urgenta Bucuresti — Bucharest
Identifiers
NCT: NCT07602088 · 54179060CLL4039