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

Janssen (J&J Innovative Medicine)

Status: Completed

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

Treatments: Drug: Ibrutinib

Study type: Observational

Funder types: Industry

Identifiers

NCT03425591

54179060CAN4001 (Other Identifier)

CR107363

Details and patient eligibility

About

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).

Enrollment: 508 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

508 participants in 2 patient groups

Cohort 1: Chronic Lymphocytic Leukemia (CLL) Participants

Description:

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.

Treatment:

Drug: Ibrutinib

Cohort 2: Mantle-Cell Lymphoma (MCL) Participants

Description:

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.

Treatment:

Drug: Ibrutinib