A phase II Study of Atezolizumab with Rituximab, Gemcitabine and Oxaliplatin in patients with relapsed or refractory Diffuse Large B-Cell Lymphoma who are not candidates for High Dose Therapy
ARGO is a phase II trial evaluating the addition of Atezolizumab to current therapy of Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) for patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) that are not candidates for high-dose therapy.
Primary objective:
Secondary objectives:
Tertiary objectives:
This is a multicentre, randomised phase IIa trial in participants with relapsed or refractory DLBCL.
We aim to recruit 112 patients. This study will have two treatment arms.
All patients will receive one cycle of R-GemOx. Three quarters of patients (Arm B) will go on to have a further 5 cycles (every 14 days) of R-GemOx with Atezolizumab, with one quarter of patients (Arm A) continuing with 5 cycles of R-GemOx.
The patients in Arm B will continue to have Atezolizumab every 21 days for 8 cycles whilst Arm A patients will enter an observational phase during this time.
Follow up will begin at 12 months from initial treatment until month 36.
This trial is now closed to recruitment. The study terminated early on 31st Jan 2021.
Patients aged ≥16 years with relapsed or refractory Diffuse Large B-Cell Lymphoma that are not candidates for high-dose therapy.
This trial is endorsed by Cancer Research UK (award reference no. C30423/A23607)
Find our more about ARGO on the Cancer Research UK website.
Katy McLaughlin
Tracey Mason
Data Manager:
Mike Radford
Alex Allen
Email: argo@soton.ac.uk
Email: ctu@soton.ac.uk
Informed Consent Form v7 29-11-2018
Patient Information Sheet v7 29-Nov-2018
Pregnant Partner Patient Information Sheet v3 30-May-2018
Pregnant Partner Informed Consent v3 06-Jun-2018
Master Patient List v1 12-Sep-2017
Patient Screening Log v3 26-Apr-2019
Staff Training Records v1 12 Sep 2017
Site Set-Up Meeting Presentation v4 2-Aug-2019
eCRF Completion guidelines for sites v3 21-Jun-2019
TENALEA User Manual ARGO v1.0 19-Sep-2017
Pharmacy Manual v4 11-Nov-2019
IMP Deviation Form_SRD-0135244_v1
Drug Request Form v2 12-Sep-2017
Atezolizumab_IB_v14_Oct2018 and Addendum_1-Dec-2018
Rituximab_IV_IB_v23 - Jul 2018
Atezolizumab Accountability Log v2 20-Nov-2019
Atezolizumab Dispensing Log v1 20-Nov-2019
Gemcitabine Accountability Log v2 20-Nov-2019
Gemcitabine Dispensing Log v1 20-Nov-2019
Oxaliplatin Accountability v2 20-Nov-2019
Oxaliplatin Dispensing Log v1 20-Nov-2019
Rituximab IV Accountability Log v2 20-Nov-2019
Rituximab IV Dispensing Log v1 20-Nov-2019
Rituximab SC Accountability Log v2 20-Nov-2019
Rituximab SC Dispensing Log v1 20-Nov-2019
Rituximab SC IB v9 - preparation reference only not RSI - Feb 2017
IMP Administration after Temp Deviation Form SRD_0103347 v6
IMP Administration After Use By Date Form SRD-0103346_v7
Instructions for SAE reporting v1 3-Oct-2017
Serious Adverse Event - ARGO SAE SUSAR Report Form v4 10-May-2019
Tissue Samples Dispatch Log HMDS and WISH v2 22 Aug 2018
Sample Shipment Form for HMDS v2 22 Aug 2018