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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

Sponsor
Johnson & Johnson Private Limited (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03190330
Collaborator
(none)
75
Enrollment
12
Locations
1
Arm
45.8
Anticipated Duration (Months)
6.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Ibrutinib 420 mg
  • Drug: Ibrutinib 560 mg
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
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
Actual Study Start Date :
Jun 26, 2019
Actual Primary Completion Date :
Apr 9, 2022
Anticipated Study Completion Date :
Apr 21, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability [Up to 13 Months]

      An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Avron Hospitals Pvt. Ltd Ahmedabad India 380013
    2 Post Graduate Institute of Medical Education & Research (PGIMER) Chandigarh India 160012
    3 Basavatarakam Indo-American Hospital Hyderabad India 500034
    4 Bhagwan Mahaveer Cancer Hospital & Research Centre Jaipur India 302017
    5 Cytecare Hospitals Pvt. Ltd Karnataka India 560064
    6 Apollo Multispeciality Hospital Ltd Kolkata India 700019
    7 Tata Medical Center Kolkata India 700156
    8 Jawaharlal Institute of Postgraduate Medical Education and Research Pondicherry India 605008
    9 Deenanath Mangeshkar Hospital and Research Centre Pune India 411004
    10 Noble Hospital Pvt Ltd Pune India 411013
    11 Regional Cancer Centre Thiruvananthapuram India 695011
    12 Christian Medical College Vellore India 632004

    Sponsors and Collaborators

    • Johnson & Johnson Private Limited

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johnson & Johnson Private Limited
    ClinicalTrials.gov Identifier:
    NCT03190330
    Other Study ID Numbers:
    • CR108316
    • 54179060LYM4005
    First Posted:
    Jun 16, 2017
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Aug 1, 2022
    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
    Additional relevant MeSH terms:
    Lymphoma
    Leukemia
    Leukemia, Lymphoid
    Leukemia, Lymphocytic, Chronic, B-Cell
    Lymphoma, Mantle-Cell

    Study Results

    No Results Posted as of Aug 12, 2022