Clinical trial NCT03476655: Clinical Outcomes of Chronic Lymphocytic Leukemia (CCL) and Mantle Cell Lymphoma (MCL) Participants Treated With Ibrutinib: A Medical Chart Review From India
Official title: Clinical Outcomes of CLL and MCL Patients Treated With Ibrutinib: An Observational Retrospective Medical Chart Review From India
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Lead sponsor: Johnson & Johnson Private Limited
Sponsor class: INDUSTRY
First posted: 2018-03-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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).


Eligibility criteria: 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

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to 14 months
measure: Time to Progression (TTP)
timeFrame: Up to 14 months
measure: Percentage of Participants with Complete Response (CR)
timeFrame: Up to 14 months
measure: Percentage of Participants with Partial Response (PR)
timeFrame: Up to 14 months
measure: Percentage of Participants with Stable Disease (SD)
timeFrame: Up to 14 months
measure: Percentage of Participants with Progressive Disease (PD)
timeFrame: Up to 14 months
Secondary outcomes:
measure: Median time to Response with Ibrutinib
timeFrame: Up to 14 months
measure: Change from Baseline in Hemoglobin Levels
timeFrame: Baseline up to 14 months
measure: Change from Baseline in Platelet Counts
timeFrame: Baseline up to 14 months
measure: Number of Participants with Response to Ibrutinib by Prior Lines of Therapy
timeFrame: Up to 14 months
measure: Number of Participants with Hematological and Non-hematological Adverse Drug Reactions (ADR)
timeFrame: Up to 14 months
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Apollo Hospitals International Limited
city: Bangalore
country: India
facility: Healthcare Global (HCG) Hospital
city: Gurgaon
country: India
facility: Fortis Memorial Research Institute
city: Hyderabad
country: India
facility: Basavatarakam Indo-American Hospital
city: Jaipur
country: India
facility: Bhagwan Mahaveer Hospital & Research Centre
city: Kolkata
country: India
facility: Tata Medical Center
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
city: Pune
country: India
facility: Yashoda Hematology Clinic
Study officials:
affiliation: Johnson & Johnson Private Limited
name: Johnson & Johnson Private Limited Clinical Trial
role: STUDY_DIRECTOR
References: