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

Study Overview
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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).

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

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

Intervention / Treatment
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* Drug: Ibrutinib


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with Chronic Lymphocytic Leukemia (CLL)<br>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<br>* 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.<br>* Other names: IMBRUVICA;|
| Participants with Mantle Cell Lymphoma (MCL)<br>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<br>* 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.<br>* Other names: IMBRUVICA;|

What is the study measuring?
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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 |