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

Completed

• Conditions: Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Mantle-Cell
• Interventions: Drug: Ibrutinib

• Registration Number: NCT03425591
• Lead Sponsor: Janssen-Cilag Ltd.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-11
• Study First Submitted: 2018-02-01
• Study First Submitted QC: 2018-02-01
• Study First Posted: 2018-02-07
• Primary Completion: 2022-08-11
• Study Completion: 2022-08-11
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-05
• Last Update Posted: 2022-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 508

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1: Chronic Lymphocytic Leukemia (CLL) Participants	Ibrutinib	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.
Cohort 2: Mantle-Cell Lymphoma (MCL) Participants	Ibrutinib	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 Measures

Name	Time	Method
Progressive-Free Survival (PFS)	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 Outcome Measures

Name	Time	Method
Number of Medications Added	Approximately up to 5 years	Number of medications added in the CLL and MCL treatment will be reported.
Overall Response Rate (ORR)	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.
Time to First Response	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.
Time to Best Response	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.
Duration of Response	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.
Overall survival (OS)	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.
Duration of Ibrutinib Therapy	Approximately up to 5 years	Duration of ibrutinib therapy in CLL and MCL participants will be reported.
Duration of a Treatment-Free Period	Every 6 months (Approximately up to 5 years)	Duration of treatment-free period in CLL and MCL participants will be reported.
Duration of the First Non-Ibrutinib Subsequent Therapy Period	Approximately up to 5 years	Duration of the first non-ibrutinib subsequent therapy period in CLL and MCL participants will be reported.
Participants' Daily Dose	Approximately up to 5 years	Daily dose of ibrutinib taken by CLL and MCL participants will be analyzed.
Number of Participants Who Require Dose Modifications	Approximately up to 5 years	Number of CLL and MCL participants requiring dose modifications in the ibrutinib therapy will be reported.