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

Leukemia, Lymphocytic, Chronic, B-Cell Clinical Trial

— FIRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03425591
• Other study ID #: CR107363
• Secondary ID: 54179060CAN4001
• Status: Completed
• Start date: May 11, 2016
• Est. completion date: August 11, 2022

Study information

• Verified date: October 2022
• Source: Janssen-Cilag Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 508
• Est. completion date: August 11, 2022
• Est. primary completion date: August 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, Mantle-Cell

Intervention

Drug:
• Ibrutinib
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag Ltd.

Country where clinical trial is conducted

France, 

Outcome

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