A Study of Ibrutinib in the Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice

Study Overview
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Brief Summary
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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).

Official Title
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A Retro-Prospective Observational Study of Ibrutinib Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice

Conditions
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Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell

Intervention / Treatment
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* Drug: Ibrutinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or mantle-cell lymphoma (MCL), and is initiating ibrutinib therapy or has initiated ibrutinib therapy on or after 21 November 2014 (date of ibrutinib commercialization) for: treatment of CLL/SLL in participants who have received at least 1 prior therapy; or treatment in first line CLL/SLL participants in the presence of deletion (del) 17p or TP53 mutation in participants unsuitable for chemo-immunotherapy; or treatment of participants with relapsed or refractory MCL Not currently participating in another investigational study, clinical study, or any expanded access program at study entry Has not participated in the ibrutinib Autorisation Temporaire d'Utilisation (ATU) program Participant must sign a written informed consent form (ICF) allowing data collection and source data verification Exclusion Criteria: Currently participating in another investigational study, clinical study, or any expanded access program at study entry Participated in the ibrutinib Autorisation Temporaire d'Utilisation (ATU) program

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1: Chronic Lymphocytic Leukemia (CLL) Participants<br>Participants with confirmed diagnosis of CLL will be observed to collect data on ibrutinib therapy to describe the effectiveness of ibrutinib and to provide a description of ibrutinib therapy and the first non-ibrutinib subsequent therapy in Cohort 1. The primary data source for this observational study will be the medical records of each enrolled participant. | Drug: Ibrutinib<br>* 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.<br>|
| Cohort 2: Mantle-Cell Lymphoma (MCL) Participants<br>Participants with confirmed diagnosis of MCL will be observed to collect data on ibrutinib therapy to describe the effectiveness of ibrutinib and to provide a description of ibrutinib therapy and the first non-ibrutinib subsequent therapy in Cohort 2. The primary data source for this observational study will be the medical records of each enrolled participant. | Drug: Ibrutinib<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Approximately up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Approximately up to 5 years | 
| Overall survival (OS) | 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. | Approximately up to 5 years | 
| Duration of Ibrutinib Therapy | Duration of ibrutinib therapy in CLL and MCL participants will be reported. | Approximately up to 5 years | 
| Duration of a Treatment-Free Period | Duration of treatment-free period in CLL and MCL participants will be reported. | 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. | Approximately up to 5 years | 
| Participants' Daily Dose | Daily dose of ibrutinib taken by CLL and MCL participants will be analyzed. | 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. | Approximately up to 5 years | 
| Number of Medications Added | Number of medications added in the CLL and MCL treatment will be reported. | Approximately up to 5 years |