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

Sponsor
Janssen-Cilag Ltd.
Study ID
NCT03425591
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — 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.

Study Details

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).

Key Dates

Start date
May 11, 2016
Status verified
Oct 2022
Primary completion
Aug 11, 2022
Completion
Aug 11, 2022

Study Design

Enrollment
508 participants (actual)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Progressive-Free Survival (PFS) [ Time Frame: Approximately up to 5 years ]

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