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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03190330
Recruitment Status : Recruiting
First Posted : June 16, 2017
Last Update Posted : December 11, 2020
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Private Limited

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
Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Mantle-Cell Drug: Ibrutinib 420 mg Drug: Ibrutinib 560 mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 26, 2019
Estimated Primary Completion Date : September 29, 2021
Estimated Study Completion Date : December 26, 2022


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 Name: Imbruvica

Drug: Ibrutinib 560 mg
Ibrutinib capsule administered orally at a dose of 560 mg for MCL participants.
Other Name: Imbruvica




Primary Outcome Measures :
  1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03190330


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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India
Vedanta Institute of Medical Science Withdrawn
Ahmedabad, India, 380009
Avron Hospitals Pvt. Ltd Not yet recruiting
Ahmedabad, India, 380013
Post Graduate Institute of Medical Education & Research (PGIMER) Not yet recruiting
Chandigarh, India, 160012
Basavatarakam Indo-American Hospital Recruiting
Hyderabad, India, 500034
Bhagwan Mahaveer Cancer Hospital & Research Centre Recruiting
Jaipur, India, 302017
Cytecare Hospitals Pvt. Ltd Not yet recruiting
Karnataka, India, 560064
Apollo Gleneagles Hospital Recruiting
Kolkata, India, 700054
Tata Medical Center Not yet recruiting
Kolkata, India, 700156
Jawaharlal Institute of Postgraduate Medical Education and Research Not yet recruiting
Pondicherry, India, 605008
Deenanath Mangeshkar Hospital and Research Centre Recruiting
Pune, India, 411004
Noble Hospital Pvt Ltd Recruiting
Pune, India, 411013
Regional Cancer Centre Not yet recruiting
Thiruvananthapuram, India, 695011
Christian Medical College Not yet recruiting
Vellore, India, 632004
Sponsors and Collaborators
Johnson & Johnson Private Limited
Investigators
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Study Director: Johnson & Johnson Private Limited Clinical Trial Johnson & Johnson Private Limited
Additional Information:
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Responsible Party: Johnson & Johnson Private Limited
ClinicalTrials.gov Identifier: NCT03190330    
Other Study ID Numbers: CR108316
54179060LYM4005 ( Other Identifier: Johnson & Johnson Private Limited )
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: December 2020

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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:
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Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Lymphoma, Non-Hodgkin