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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

508 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-11

Study Completion Date

2022-08-11

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).

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1: Chronic Lymphocytic Leukemia (CLL) Participants

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.

Ibrutinib

Intervention Type DRUG

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.

Cohort 2: Mantle-Cell Lymphoma (MCL) Participants

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.

Ibrutinib

Intervention Type DRUG

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.

Interventions

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Ibrutinib

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.

Intervention Type DRUG

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:

1. treatment of CLL/SLL in participants who have received at least 1 prior therapy; or
2. treatment in first line CLL/SLL participants in the presence of deletion (del) 17p or TP53 mutation in participants unsuitable for chemo-immunotherapy; or
3. 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No