APOLLO
Research type
Research Study
Full title
A Polatuzumab Vedotin Containing Chemo-Immunotherapeutic Regimen in Patients with Diffuse Large B-Cell Lymphoma Unsuitable for Full Dose R-CHOP Therapy
IRAS ID
261164
Contact name
Nagesh Kalakonda
Contact email
Sponsor organisation
The Clatterbridge Cancer Centre NHS Foundation Trust
Eudract number
2019-000842-36
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Diffuse large B cell lymphoma (DLBCL) is a cancer of the lymphatic system where B-cells (a type of white blood cell) experience uncontrolled growth. Current standard of care treatment for patients with DLBCL comprises 6-8 cycles of a chemo-immunotherapy regimen called R-CHOP.
An important component of R-CHOP is an anthracycline called doxorubicin, which increases the risk of cardiotoxicity in patients with suboptimal cardiac function and co-morbidities (hypertension, ischaemic heart disease, diabetes mellitus etc.). As a result, doxorubicin is often replaced with other agents such as gemcitabine or etoposide, or, dose reductions are applied, both of which are likely to be detrimental to outcomes. In addition, there is evidence that patients over the age of 80 years are unsuitable for full-dose R-CHOP due to toxicity, even in the absence of co-morbidities.
Polatuzumab vedotin (POLA) is a novel drug combining an antibody to CD79b, an antigen present on the surface of lymphoma cells, and a drug called MMAE, which inhibits cell division and growth. POLA has been shown to have demonstrable activity in DLBCL and is safe to combine with otherwise sub-optimal chemo-immunotherapeutic backbones such as R-GCP or R-mini-CHP.
The aim of this study is to determine the efficacy and safety of adding POLA to R-GCP or R-mini-CHP in the frontline treatment of patients with DLBCL who are otherwise unsuitable for full-dose R-CHOP.
Patients will receive either POLA-R-GCP or POLA-R-mini-CHP based on the presence or absence of cardiac co-morbidities for six cycles of treatment and will be followed up, post-treatment, for up to two years. Lymphoma will be monitored using PET and/or CT scans before and after treatment.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0743
Date of REC Opinion
7 Apr 2020
REC opinion
Further Information Favourable Opinion