Clinical Outcomes of Chronic Lymphocytic Leukemia (CCL) and Mantle Cell Lymphoma (MCL) Participants Treated With Ibrutinib: A Medical Chart Review From India

NCT ID: NCT03476655

Last Updated: 2025-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-28

Study Completion Date

2019-05-31

Brief Summary

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The purpose of this study is to describe the effectiveness (overall response rate \[ORR\] and time to progression \[TPP\]) of Ibrutinib therapy in participants with chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL).

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Participants with Chronic Lymphocytic Leukemia (CLL)

This study will collect retrospective data on effectiveness and outcome parameters for participants of CLL being managed with ibrutinib in the clinical practice. The primary data source for this observational study will be the medical records of each enrolled participant.

Ibrutinib

Intervention Type DRUG

No study treatment will be administered as a part of this study. Participants in this observational study with confirmed diagnosis of CLL and MCL receiving ibrutinib treatment before 30 April 2018 in routine clinical practice settings will be observed.

Participants with Mantle Cell Lymphoma (MCL)

This study will collect retrospective data on effectiveness and outcome parameters for participants of MCL being managed with ibrutinib in the clinical practice. The primary data source for this observational study will be the medical records of each enrolled participant.

Ibrutinib

Intervention Type DRUG

No study treatment will be administered as a part of this study. Participants in this observational study with confirmed diagnosis of CLL and MCL receiving ibrutinib treatment before 30 April 2018 in routine clinical practice settings will be observed.

Interventions

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Ibrutinib

No study treatment will be administered as a part of this study. Participants in this observational study with confirmed diagnosis of CLL and MCL receiving ibrutinib treatment before 30 April 2018 in routine clinical practice settings will be observed.

Intervention Type DRUG

Other Intervention Names

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IMBRUVICA

Eligibility Criteria

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Inclusion Criteria

* Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL)
* CLL or MCL participants being newly initiated on Imbruvica treatment (ibrutinib capsule 140 mg) based on independent clinical judgment of treating physicians

Exclusion Criteria

\- Any contraindications to ibrutinib use according to the current version of the Prescribing information in India
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Private Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johnson & Johnson Private Limited Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Private Limited

Locations

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Apollo Hospitals International Limited

Ahmedabad, , India

Site Status

Healthcare Global (HCG) Hospital

Bangalore, , India

Site Status

Fortis Memorial Research Institute

Gurgaon, , India

Site Status

Basavatarakam Indo-American Hospital

Hyderabad, , India

Site Status

Bhagwan Mahaveer Hospital & Research Centre

Jaipur, , India

Site Status

Tata Medical Center

Kolkata, , India

Site Status

All India Institute of Medical Sciences

New Delhi, , India

Site Status

Yashoda Hematology Clinic

Pune, , India

Site Status

Countries

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India

Other Identifiers

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54179060LYM4007

Identifier Type: OTHER

Identifier Source: secondary_id

CR108441

Identifier Type: -

Identifier Source: org_study_id

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