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

Leukemia, Lymphocytic, Chronic, B-Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03476655
• Other study ID #: CR108441
• Secondary ID: 54179060LYM4007
• Status: Completed
• Start date: April 28, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: August 2020
• Source: Johnson & Johnson Private Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 31, 2019
• Est. primary completion date: May 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
India	Apollo Hospitals International Limited	Ahmedabad
India	Healthcare Global (HCG) Hospital	Bangalore
India	Fortis Memorial Research Institute	Gurgaon
India	Basavatarakam Indo-American Hospital	Hyderabad
India	Bhagwan Mahaveer Hospital & Research Centre	Jaipur
India	Tata Medical Center	Kolkata
India	All India Institute of Medical Sciences	New Delhi
India	Yashoda Hematology Clinic	Pune

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Private Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Change from Baseline in Hemoglobin Levels	Change from baseline in blood hemoglobin level will be reported.	Baseline up to 14 months
Secondary	Change from Baseline in Platelet Counts	Change from baseline in blood platelet counts will be reported.	Baseline up to 14 months
Secondary	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
Secondary	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