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

Johnson & Johnson (J&J)

Status: Completed

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

Treatments: Drug: Ibrutinib

Study type: Observational

Funder types: Industry

Identifiers

NCT03476655

54179060LYM4007 (Other Identifier)

CR108441

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Participants with Chronic Lymphocytic Leukemia (CLL)

Description:

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.

Treatment:

Drug: Ibrutinib

Participants with Mantle Cell Lymphoma (MCL)

Description:

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.

Treatment:

Drug: Ibrutinib