Real-World study on Relapsed/Refractory Indolent Non-Hodgkin Lymphoma
Research type
Research Study
Full title
Real-World Response/Survival and Treatment Patterns among Patients with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma in USA, UK, France, and Spain Oncology Practices
IRAS ID
281241
Contact name
Nikita Jeswani
Contact email
Sponsor organisation
Kite Pharma, Inc
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
Indolent non-Hodgkin lymphomas (iNHL) comprise approximately one-third of malignant lymphomas, while Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL) account for approximately 20% and 12% of all NHLs, respectively. It is reported that the incidence of FL ranges from 2.1-4.3/100,000 while for MZL from 0.5-2.6/100,000. FL is the most common subtype of iNHL and is considered to be incurable with front-line therapies. ORRs with front-line chemoimmunotherapy with an alkylator and anti-CD20 are nearly 100%, however ~20% of the treated FL patients relapse within 2 years of diagnosis. This group of patients is in need of new and efficacious treatments, as are patients with iNHL who have relapsed following more than 1 line of combination chemotherapy, particularly those who progress rapidly (refractory).
Anti-CD19 CAR-T cells with CD28 and CD3ƺ signalling domains have shown activity in patients with B-cell cancers. CAR-T therapy (axicabtagene ciloleucel) is already indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma, after 2 or more lines of systemic therapy. Recently, axicabtagene ciloleucel has entered clinical trial development in patients with r/r iNHL. A phase 2 single-arm study, ZUMA-5 (NCT03105336), is ongoing; the objective is to evaluate efficacy and safety of axicabtagene ciloleucel in patients with r/r B-cell iNHL. However, being a single-arm study, direct comparison to standard of care (SOC) is not possible.
This global, non-interventional, retrospective, multi-center study aims to construct a real-world patient cohort that is similar in terms of baseline and disease characteristics to the patient population enrolled in the ongoing ZUMA-5 study. This real-world cohort may be used as an external control for the ZUMA-5 clinical trial. It could also help define the potential incremental gains of study patients when building out a cost-effectiveness model for health technology assessment (HTA) purposes.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
20/LO/0648
Date of REC Opinion
22 May 2020
REC opinion
Further Information Favourable Opinion