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

First listed
Feb 7, 2018
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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