The purpose of this study is to describe the effectiveness of ibrutinib and to provide a description of ibrutinib therapy and the first non-ibrutinib subsequent therapy for chronic lymphocytic leukemia (CLL) and mantle-cell lymphoma (MCL).
Study Type
OBSERVATIONAL
Enrollment
508
Participants in this observational study with confirmed diagnosis of CLL and MCL receiving ibrutinib in routine clinical practice settings will be observed for 5 years.
Unnamed facility
Paris, France
Progressive-Free Survival (PFS)
PFS in Chronic Lymphocytic Leukemia (CLL) and Mantle-Cell Lymphoma (MCL) participants will be determined. PFS is defined as the time from start of ibrutinib therapy to Progressive Disease (PD) or death from any cause. PD is defined as any new lesions or increase by greater than or equal to (\>=) 50 percent (%) of previously involved sites from nadir.
Time frame: Approximately up to 5 years
Overall Response Rate (ORR)
ORR observed in CLL and MCL participants will be reported. ORR is defined as the proportion of participants with at least an objective response (that is, complete response or partial response, or partial response with lymphocytosis for CLL participants) as assessed by the participating physician.
Time frame: Approximately up to 5 years
Time to First Response
Time to First Response in CLL and MCL participants will be reported. Time to first response is defined as the time from start of ibrutinib therapy until first objective response.
Time frame: Approximately up to 5 years
Time to Best Response
Time to best response in CLL and MCL participants will be reported. Time to best response is defined as the time from start of ibrutinib therapy until best objective response.
Time frame: Approximately up to 5 years
Duration of Response
Duration of response in CLL and MCL participants will be reported. Duration of response is defined as the time from start of ibrutinib therapy until PD or death resulting from progression. PD is defined as any new lesions or increase by \>=50% of previously involved sites from nadir.
Time frame: Approximately up to 5 years
Overall survival (OS)
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Overall survival in CLL and MCL participants will be reported. Overall survival will be measured from start of ibrutinib therapy to the date of death (all-cause mortality); and from diagnosis to the date of death.
Time frame: Approximately up to 5 years
Duration of Ibrutinib Therapy
Duration of ibrutinib therapy in CLL and MCL participants will be reported.
Time frame: Approximately up to 5 years
Duration of a Treatment-Free Period
Duration of treatment-free period in CLL and MCL participants will be reported.
Time frame: Every 6 months (Approximately up to 5 years)
Duration of the First Non-Ibrutinib Subsequent Therapy Period
Duration of the first non-ibrutinib subsequent therapy period in CLL and MCL participants will be reported.
Time frame: Approximately up to 5 years
Participants' Daily Dose
Daily dose of ibrutinib taken by CLL and MCL participants will be analyzed.
Time frame: Approximately up to 5 years
Number of Participants Who Require Dose Modifications
Number of CLL and MCL participants requiring dose modifications in the ibrutinib therapy will be reported.
Time frame: Approximately up to 5 years
Number of Medications Added
Number of medications added in the CLL and MCL treatment will be reported.
Time frame: Approximately up to 5 years