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.
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
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
The study will include adult participants with a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) requiring first-line treatment, per international workshop on chronic lymphocytic leukemia (iwCLL) 2018 criteria or at the discretion of the treating physician using I+V treatment in routine clinical practice.
Cohort
Prospective
Not listed
Overall Response Rate (ORR)
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 \[PR-L\]).
Number of Participants with Factors Affecting the Physician Treatment Decision Using the Physician's Treatment Decision Questionnaire
Participants with factors affecting the physicians treatment decision using the physician's treatment decision questionnaire (European Organization for Research and Treatment of Cancer \[EORTC\] Quality of Life Questionnaire\]) will be reported.
Number of Participants with Factors Affecting Participant's Decision to Accept or Continue with the Proposed Treatment Using the Physician's Treatment Decision Questionnaire
Participants with factors affecting the participant's decision to accept or continue with the proposed treatment using the physician's treatment decision questionnaire (EORTC Quality of Life Questionnaire) will be reported.
Overall Response Rate (ORR) By the End of Treatment Cycles
ORR is defined as the percentage of participants achieving the best response of complete or partial response (including CR, CRi, PR or PR-L).
Duration of response (DoR)
DoR is defined as time (in months ) from the first date of achieving complete or partial response (including CR, CRi, PR, or PR-L) to the date of first documented evidence of progressive disease (PD) or death.
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