A Study to Assess Safety of ImbruvicaTM in Indian Participants With Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy or Chronic Lymphocytic Leukemia With 17p Deletion

A Prospective, Multicenter, Open Label Single Arm Phase IV Clinical Trial to Assess Safety of ImbruvicaTM (Ibrutinib Capsules 140 mg) in Indian Patients With Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy or Chronic Lymphocytic Leukemia With 17p Deletion

The primary purpose of this study is to evaluate the post-marketing safety of ImbruvicaTM (ibrutinib capsule 140 milligram [mg]) under actual conditions of use, and to understand the incidence of adverse events (AEs) (serious and non-serious AEs).

Study Overview

• Status: Completed
• Conditions: Lymphoma, Mantle-Cell; Leukemia, Lymphocytic, Chronic, B-Cell
• Intervention / Treatment: Drug: Ibrutinib 420 mg; Drug: Ibrutinib 560 mg

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Ahmedabad, India, 380013
    • Avron Hospitals Pvt. Ltd
  • Chandigarh, India, 160012
    • Post Graduate Institute of Medical Education And Research PGIMER
  • Hyderabad, India, 500034
    • Basavatarakam Indo-American Hospital
  • Jaipur, India, 302017
    • Bhagwan Mahaveer Cancer Hospital & Research Centre
  • Karnataka, India, 560064
    • Cytecare Hospitals Pvt. Ltd
  • Kolkata, India, 700156
    • Tata Medical Center
  • Kolkata, India, 700019
    • Apollo Multispeciality Hospital Ltd
  • Pondicherry, India, 605008
    • Jawaharlal Institute Of Postgraduate Medical Education And Research
  • Pune, India, 411004
    • Deenanath Mangeshkar Hospital and Research Centre
  • Pune, India, 411013
    • Noble Hospital Pvt Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL) participants being newly initiated on Imbruvica treatment (ibrutinib capsule 140 milligram [mg]) based on independent clinical judgment of treating physicians as per locally approved prescribing information
• Must give a written informed consent indicating that they understand the purpose and are willing to participate in the study and allowing data collection and source data verification in accordance with regulatory requirements

Exclusion Criteria:

• Participants who are not eligible to receive Imbruvica as per the locally approved prescribing information
• Participants participating or planning to participate in any interventional drug trial during the course of this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ibrutinib; Participants will receive ibrutinib 420 milligram (mg) (three 140 mg capsules) as a single daily dose for chronic lymphocytic leukemia (CLL) and 560 mg (four 140 mg capsules) as a single daily dose for mantle cell lymphoma (MCL) for up to 12 months or till disease progression, whichever is earlier.	Drug: Ibrutinib 420 mg; Ibrutinib capsule administered orally at a dose of 420 mg for CLL participants.; Other Names: Imbruvica; Drug: Ibrutinib 560 mg; Ibrutinib capsule administered orally at a dose of 560 mg for MCL participants.; Other Names: Imbruvica

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Any AE occurred at or after the initial administration of study drug up to maximum of 30 days after last dose was considered as treatment emergent.	Day 1 up to 30 days after last dose of study drug (up to 13 months)
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE which resulted in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurred at or after the initial administration of study drug up to maximum of 30 days after last dose was considered as treatment emergent.	Day 1 up to 30 days after last dose of study drug (up to 13 months)

Collaborators and Investigators

• Sponsor: Johnson & Johnson Private Limited
• Investigators: Study Director: Johnson & Johnson Private Limited Clinical Trial, Johnson & Johnson Private Limited

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2019
• Primary Completion (Actual): May 3, 2023
• Study Completion (Actual): May 3, 2023

Study Registration Dates

• First Submitted: June 14, 2017
• First Submitted That Met QC Criteria: June 14, 2017
• First Posted (Actual): June 16, 2017

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Leukemia, B-Cell; Leukemia; Lymphoma; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Mantle-Cell; Tyrosine Kinase Inhibitors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Ibrutinib
• Other Study ID Numbers: CR108316; 54179060LYM4005 (Other Identifier: Johnson & Johnson Private Limited)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes