Retrospective data study among patients with R/R Mantle Cell Lymphoma
Research type
Research Study
Full title
Real-World Survival, Treatment Patterns, and Healthcare Resource Utilization Among Patients with Relapsed/Refractory Mantle Cell Lymphoma in Europe
IRAS ID
278663
Contact name
Kim Linton
Contact email
Sponsor organisation
Kite Pharma, Inc.
Duration of Study in the UK
0 years, 10 months, 8 days
Research summary
This is a retrospective, observational, multicenter, chart-review study in patients with Relapsed/refractory (r/r) Mantle cell lymphoma (MCL). Participants are eligible if they received Bruton’s tyrosine kinase inhibitor (BTKi) therapy.
The purpose of this study is to estimate real world overall survival among participants with relapsed or refractory mantle cell lymphoma after treatment with a BTK (Bruton’s tyrosine kinase) inhibitor, and also to describe treatment patterns and healthcare resource utilisation in this patient population. BTK is a protein (an enzyme) in the B cell receptor pathway that plays a key role in proliferation and survival of cancer cells. The aim of the study is to help advance the state of knowledge about the disease and patient outcomes.
A retrospective study means that data from procedures and tests participants have previously undertaken and other information about the healthcare they previously received will be collected from their medical records.
The study will take place in a number of study sites in different European Union (EU) countries, including the UK, France and Italy. The study is expected to last approximately 10 months. The specific data already in participants medical records will be collected and analysed.
Participation in this study does not require participants to have any extra medical procedures or tests (there is no direct participation required other than participants consent to release their medical records for research purposes.). There is no investigational drug treatment given in this study. No additional procedures will be performed in this study other than collecting participants data.
The sponsor has appointed the research organisations RJM and AIXIAL who will work together with study sites to collect specific data already in the medical records. RJM and Aixal will not collect personal identifiers such as participants name, address, initials or date of birth. Instead, they will be given a specific patient number.
The data to be collected are: participants age, sex/gender, and health data.
The health data to be collected are: participant’s state of health and diseases including any medical and surgical history; any treatments and their response to treatments; diagnosis and prognostic data about their disease; results obtained from assessing participants X-rays or CT scans (but not collecting the X-rays or CT scans themselves).
The sponsor of the non-interventional study is Kite Pharma, Inc, a wholly owned subsidiary of Gilead Sciences Inc, whose representative in the European Union is Kite Pharma Eu BV (Netherlands).REC name
South Central - Hampshire B Research Ethics Committee
REC reference
20/SC/0170
Date of REC Opinion
27 Apr 2020
REC opinion
Favourable Opinion