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

Sponsor
Johnson & Johnson Private Limited
Study ID
NCT03476655
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — 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.

Study Details

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).

Key Dates

Start date
Apr 28, 2018
Status verified
Jan 2025
Primary completion
May 14, 2019
Completion
May 31, 2019

Study Design

Enrollment
40 participants (actual)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to 14 months ]

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