Clinical trial NCT03425591: A Study of Ibrutinib in the Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice
Official title: A Retro-Prospective Observational Study of Ibrutinib Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Lead sponsor: Janssen-Cilag Ltd.
Sponsor class: INDUSTRY
First posted: 2018-02-07
Enrollment: 508
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population include chronic lymphocytic leukemia (CLL) or mantle-cell lymphoma (MCL) participants who were or will be treated by ibrutinib per routine clinical care on or after 21 November 2014.

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Progressive-Free Survival (PFS)
timeFrame: Approximately up to 5 years
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Approximately up to 5 years
measure: Time to First Response
timeFrame: Approximately up to 5 years
measure: Time to Best Response
timeFrame: Approximately up to 5 years
measure: Duration of Response
timeFrame: Approximately up to 5 years
measure: Overall survival (OS)
timeFrame: Approximately up to 5 years
measure: Duration of Ibrutinib Therapy
timeFrame: Approximately up to 5 years
measure: Duration of a Treatment-Free Period
timeFrame: Every 6 months (Approximately up to 5 years)
measure: Duration of the First Non-Ibrutinib Subsequent Therapy Period
timeFrame: Approximately up to 5 years
measure: Participants' Daily Dose
timeFrame: Approximately up to 5 years
measure: Number of Participants Who Require Dose Modifications
timeFrame: Approximately up to 5 years
measure: Number of Medications Added
timeFrame: Approximately up to 5 years
Other outcomes:
Locations:
city: Paris Cedex 13
country: France
Study officials:
affiliation: Janssen-Cilag Ltd.
name: Janssen-Cilag Ltd. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Dartigeas C, Slama B, Doyle M, Tapprich C, Albrecht C, Dupuis S, Wapenaar R, Schmidt-Hieber C, Leblond V. FIRE Study: Real-World Effectiveness and Safety of Ibrutinib in Clinical Practice in Patients with CLL and MCL. Clin Hematol Int. 2022 Sep;4(3):65-74. doi: 10.1007/s44228-022-00015-5. Epub 2022 Sep 14.