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

Clinical Outcomes of CLL and MCL Patients Treated With Ibrutinib: An Observational Retrospective Medical Chart Review From India

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).

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• India
  • Ahmedabad, India, 382428
    • Apollo Hospitals International Limited
  • Bangalore, India, 560013
    • Healthcare Global (HCG) Hospital
  • Gurgaon, India, 122002
    • Fortis Memorial Research Institute
  • Hyderabad, India, 500034
    • Basavatarakam Indo-American Hospital
  • Jaipur, India, 302017
    • Bhagwan Mahaveer Hospital & Research Centre
  • Kolkata, India, 700156
    • Tata Medical Center
  • New Delhi, India, 110029
    • All India Institute of Medical Sciences
  • Pune, India, 411002
    • Yashoda Hematology Clinic

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Study population include chronic lymphocytic leukemia (CLL) or mantle-cell lymphoma (MCL) participants treated with ibrutinib per routine clinical care before 30 April 2018 in India and who have progressed on at least one prior line of therapy or CLL participants with deletion 17p (deletions in the short arm of chromosome 17).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: 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.; Other Names: IMBRUVICA
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.	Drug: 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.; Other Names: IMBRUVICA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	ORR is defined as achievement of complete response (CR) or partial response (PR) per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 guidelines for Chronic Lymphocytic Leukemia (CLL) and Mantle-cell Lymphoma (MCL). CR is defined as resolution of enlarged lymph nodes, spleen and liver; normalization of blood counts (neutrophils, hemoglobin, platelets); no residual CLL/MCL detectable in the bone marrow. PR is defined as 50 percent (%) or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more reduction in the blood lymphocyte count.	Up to 14 months
Time to Progression (TTP)	Time to progression will be reported for the observed participants receiving ibrutinib. TTP is defined as the period from study entry until objective disease progression (time from the date of randomization until disease progression or death due to progression, whichever occur first).	Up to 14 months
Percentage of Participants with Complete Response (CR)	Percentage of participants with CR will be reported. CR is defined as resolution of enlarged lymph nodes, spleen and liver; normalization of blood counts (neutrophils, hemoglobin, platelets); no residual CLL/MCL detectable in the bone marrow.	Up to 14 months
Percentage of Participants with Partial Response (PR)	Percentage of participants with PR will be reported. PR is defined as 50 percent (%) or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more reduction in the blood lymphocyte count.	Up to 14 months
Percentage of Participants with Stable Disease (SD)	Percentage of participants with SD will be reported. Participants who have not achieved a CR or a PR, and who have not exhibited progressive disease will be considered to have stable disease.	Up to 14 months
Percentage of Participants with Progressive Disease (PD)	Percentage of participants with PD will be reported. PD is defined as 50% or more increase in lymph nodes or the appearance of new enlarged lymph nodes; 50% or more increase in the size of the spleen or liver; 50% or more increase in blood lymphocyte count.	Up to 14 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median time to Response with Ibrutinib	Median time to response with ibrutinib in CLL and MCL participants will be reported. Time to response is defined as the time from start of ibrutinib therapy until objective response (CR or PR assessed by the investigator, based on physical examinations, CT scans, laboratory results, and bone marrow examinations, according to the modified 2008 IWCLL response criteria).	Up to 14 months
Change from Baseline in Hemoglobin Levels	Change from baseline in blood hemoglobin level will be reported.	Baseline up to 14 months
Change from Baseline in Platelet Counts	Change from baseline in blood platelet counts will be reported.	Baseline up to 14 months
Number of Participants with Response to Ibrutinib by Prior Lines of Therapy	Number of participants, who progresses on at least one prior line of therapy, with response to ibrutinib will be reported.	Up to 14 months
Number of Participants with Hematological and Non-hematological Adverse Drug Reactions (ADR)	Number of participants with hematological and non-hematological ADR will be reported. An adverse drug reaction (ADR) is defined as a response to a medicinal (investigational or non-investigational) product that is noxious and unintended. The phrase "response to a medicinal product" means that a causal relationship between a medicinal product and an adverse event is possible, probable or very likely.	Up to 14 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): April 28, 2018
• Primary Completion (Actual): May 14, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: March 19, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 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: CR108441; 54179060LYM4007 (Other Identifier: Johnson & Johnson Private Limited)

Drug and device information, study documents

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