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

NCT03425591 | Completed FDA Drug

• 2 other identifiers: CR10736354179060CAN4001
• Study Type: observational
• Target: 508
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Overall Response Rate (ORR)

  Approximately up to 5 years

• Time to First Response

  Approximately up to 5 years

• Time to Best Response

  Approximately up to 5 years

• Duration of Response

  Approximately up to 5 years

• Overall survival (OS)

  Approximately up to 5 years

Study Arms (2)

Cohort 1: Chronic Lymphocytic Leukemia (CLL) Participants

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.

Drug: Ibrutinib

Cohort 2: Mantle-Cell Lymphoma (MCL) Participants

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.

Drug: Ibrutinib

Interventions

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.

Cohort 1: Chronic Lymphocytic Leukemia (CLL) Participants; Cohort 2: Mantle-Cell Lymphoma (MCL) Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag Ltd.: lead

Study Sites (1)

Unknown Facility

Paris, France

Location

Related Publications (2)

• Dartigeas C, Quinquenel A, Ysebaert L, Dilhuydy MS, Anglaret B, Slama B, Le Du K, Tardy S, Tchernonog E, Orfeuvre H, Voillat L, Guidez S, Malfuson JV, Dupuis S, Deslandes M, Feugier P, Leblond V; FIRE Investigators Group. Final results on effectiveness and safety of Ibrutinib in patients with chronic lymphocytic leukemia from the non-interventional FIRE study. Ann Hematol. 2025 Feb;104(2):1079-1093. doi: 10.1007/s00277-024-05666-3. Epub 2024 Mar 6.

  PMID: 38443660 DERIVED

• 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.

  PMID: 36103041 DERIVED

MeSH Terms

Conditions

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

Interventions

ibrutinib

Condition Hierarchy (Ancestors)

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

Study Officials

• Janssen-Cilag Ltd. Clinical Trial

  Janssen-Cilag Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 7, 2018
• Study Start: May 11, 2016
• Primary Completion: August 11, 2022
• Study Completion: August 11, 2022
• Last Updated: October 6, 2022

Record last verified: 2022-10

Locations

FR (1)