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

NCT03476655 | Completed

• 2 other identifiers: CR10844154179060LYM4007
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 8

Brief Summary

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).

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Median time to Response with Ibrutinib

  Up to 14 months

• Change from Baseline in Hemoglobin Levels

  Baseline up to 14 months

• Change from Baseline in Platelet Counts

  Baseline up to 14 months

• Number of Participants with Response to Ibrutinib by Prior Lines of Therapy

  Up to 14 months

• Number of Participants with Hematological and Non-hematological Adverse Drug Reactions (ADR)

  Up to 14 months

Study Arms (2)

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

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

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.

Also known as: IMBRUVICA

Participants with Chronic Lymphocytic Leukemia (CLL); Participants with Mantle Cell Lymphoma (MCL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Johnson & Johnson Private Limited: lead

Study Sites (8)

Apollo Hospitals International Limited

Ahmedabad, 382428, India

Location

Healthcare Global (HCG) Hospital

Bangalore, 560013, India

Location

Fortis Memorial Research Institute

Gūrgaon, 122002, India

Location

Basavatarakam Indo-American Hospital

Hyderabad, 500034, India

Location

Bhagwan Mahaveer Hospital & Research Centre

Jaipur, 302017, India

Location

Tata Medical Center

Kolkata, 700156, India

Location

All India Institute of Medical Sciences

New Delhi, 110029, India

Location

Yashoda Hematology Clinic

Pune, 411002, India

Location

MeSH Terms

Conditions

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

Interventions

ibrutinib

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma

Study Officials

• Johnson & Johnson Private Limited Clinical Trial

  Johnson & Johnson Private Limited

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: March 26, 2018
• Study Start: April 28, 2018
• Primary Completion: May 14, 2019
• Study Completion: May 31, 2019
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

IN (8)