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Completed

NCT Number: NCT03425591

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

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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Key information

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Progressive-Free Survival (PFS)

    Time frame: Approximately up to 5 years

    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.

Secondary outcomes

  1. Overall Response Rate (ORR)

    Time frame: Approximately up to 5 years

    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.

  2. Time to First Response

    Time frame: Approximately up to 5 years

    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.

  3. Time to Best Response

    Time frame: Approximately up to 5 years

    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.

  4. Duration of Response

    Time frame: Approximately up to 5 years

    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.

  5. Overall survival (OS)

    Time frame: Approximately up to 5 years

    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.

  6. Duration of Ibrutinib Therapy

    Time frame: Approximately up to 5 years

    Duration of ibrutinib therapy in CLL and MCL participants will be reported.

  7. Duration of a Treatment-Free Period

    Time frame: Every 6 months (Approximately up to 5 years)

    Duration of treatment-free period in CLL and MCL participants will be reported.

  8. Duration of the First Non-Ibrutinib Subsequent Therapy Period

    Time frame: Approximately up to 5 years

    Duration of the first non-ibrutinib subsequent therapy period in CLL and MCL participants will be reported.

  9. Participants' Daily Dose

    Time frame: Approximately up to 5 years

    Daily dose of ibrutinib taken by CLL and MCL participants will be analyzed.

  10. Number of Participants Who Require Dose Modifications

    Time frame: Approximately up to 5 years

    Number of CLL and MCL participants requiring dose modifications in the ibrutinib therapy will be reported.

  11. Number of Medications Added

    Time frame: Approximately up to 5 years

    Number of medications added in the CLL and MCL treatment will be reported.

Sponsors and collaborators

Lead sponsor

Janssen-Cilag Ltd.

Industry

Registry information

Official study title

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

Acronym: FIRE

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Feb 7, 2018
Registry last updated
Oct 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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