chronic lymphocytic leukemia/ small lymphocytic lymphoma: CLL/ SLL
Conditions
Interventions
None listed
Sponsors
J&J Innovative Medicine Medical Affairs Division
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patient aged at least 20 years of age at the time of ibrutinib initiation 2. Must have a confirmed diagnosis of CLL in accordance with local practice 3. Must have initiated ibrutinib for either 1L or RR CLL between 1 July 2018 and 31 December 2020 (inclusive) at the participating site 4. Patients whose consent to participate in this study has been obtained from the patient or the legally acceptable representative (However, if the Independent Ethics Committee/Institutional Review Board approves, including cases in which it is difficult to obtain consent from the patient or the legally acceptable representative due to death or other reasons, opt-out enrollment will be permitted.)
Exclusion criteria
Exclusion criteria: 1. Patients who were treated with ibrutinib without following the instructions in the package insert 2. Must have a confirmed diagnosis of CLL in accordance with local practice 3. Must have initiated ibrutinib for either 1L or RR CLL between 1 July 2018 and 31 December 2020 (inclusive) at the participating site 4. Patients whose consent to participate in this study has been obtained from the patient or the legally acceptable representative (However, if the Independent Ethics Committee/Institutional Review Board approves, including cases in which it is difficult to obtain consent from the patient or the legally acceptable representative due to death or other reasons, opt-out enrollment will be permitted.) 5. Received an investigational drug or used an invasive investigational medical device within the period from the start date of the treatment through to cessation of ibrutinib. [Note: investigational treatments after progression from ibrutinib or discontinuation of ibrutinib are allowable] 6. Was enrolled in another Janssen-sponsored study (including post-marketing surveillance) between their initiation of ibrutinib and end of their data collection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 36-month PFS rate in 1L CLL population | — |
Secondary
| Measure | Time frame |
|---|---|
| To describe the longer-term clinical outcomes (e.g., Best Response (BR) ) of patients initiating ibrutinib treatment for 1L CLL in Japan To describe the longer-term clinical outcomes (e.g., 36-month PFS rate, BR) of patients initiating ibrutinib treatment for RR CLL in Japan To investigate how ibrutinib-treated CLL patients are managed in routine clinical practice in Japan (including specific prophylaxis and treatment modifications) - particularly those at risk of or experiencing specific AEs To describe the characteristics of patients initiating ibrutinib as a first-line treatment for CLL in routine clinical practice in Japan To describe the characteristics of patients initiating ibrutinib as a treatment for RR CLL in routine clinical practice in Japan | — |
Countries
Japan
Contacts
Public ContactAi Omi
J&J Innovative Medicine Medical Affairs Division
Outcome results
None listed