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The University of Southampton
Southampton Clinical Trials Unit

ARGO

Title

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

Description

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.

Objectives

Primary objective:

  • To document the durable anti-tumour activity of R-GemOx-Atezo in patients with relapsed or refractory DLBCL.

Secondary objectives:

  • To determine the safety and toxicity profile of R-GemOx-Atezo regimen.
  • To document the anti-tumour activity of R-GemOx-Atezo in patients with relapsed or refractory DLBCL.
  • To document the durability of R-GemOx-Atezo in patients with relapsed or refractory DLBCL.
  • To determine the overall survival of patients treated R-GemOx-Atezo.

Tertiary objectives:

  • To correlate clinical outcomes with gene expression analysis of PD-1, PD-L1, PD-L2 and other immune signatures from primary tumour material.
  • To correlate clinical outcomes with immunohistochemical expression in tumour material of PD-1, PD-L1, PD-L2 and other markers in both tumour and microenvironment.
  • To correlate clinical outcomes with expression of PD-1, PD-L1/L2 on peripheral blood T-cells. Sub division of T-lymphocyte sub-sets.
  • To determine the profile of recurrent mutations observed in patients with DLBCL in this population and correlate to clinical response.
  • To correlate clinical outcomes with known prognostic molecular features in DLBCL.
  • To correlate clinical outcomes with cell of origin of DLBCL (ABC, GCB, unclassified).
  • To examine use of plasma nucleic acid as a surrogate target in DLBCL and observation of dynamic change during study period.
  • To examine the link between tumour-infiltrating T cell repertoire in pre-treatment biopsies and clinical outcomes.

Trial Design

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.

Trial Status

Open to recruitment

Population

Patients aged ≥16 years with relapsed or refractory Diffuse Large B-Cell Lymphoma that are not candidates for high-dose therapy.

Trial Team:

Senior Trial Manager:

Josh Caddy (023 8120 5537)

Trial Manager:

Olana Tansley-Hancock (023 8120 5557)

Clinical Data Coordinator:

Stephanie Hill (023 8120 5675)

Contact Information:

Email: argo@soton.ac.uk

Fax: 0844 7740621

SAE Reporting: ctu@soton.ac.uk or 0844 7740621

Essential Documents

GP letter v3 4 Dec 2017

Informed Consent Form v7 29-11-2018

Patient Information Sheet v7 29-Nov-2018

Protocol v5 05-Mar-2019

Pregnant Partner Patient Information Sheet v3 30-May-2018

Pregnant Partner Informed Consent v3 06-Jun-2018

ISF Documents

Master Patient List v1 12-Sep-2017

Patient Screening Log v3 26-Apr-2019

Staff Training Records v1 12 Sep 2017

Site Visit Log v2 25-Jul-2018 

Site Set-Up Meeting Presentation v4 2-Aug-2019

Patient Registration and Randomisation

eCRF Completion guidelines for sites v3 21-Jun-2019

TENALEA User Manual ARGO v1.0 19-Sep-2017

Pharmacy Documents

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

SmPC Gemcitabine 15-Mar-2017

SmPC Oxaliplatin 2-Jan-2018

Rituximab_IV_IB_v23 - Jul 2018

Rituximab SC IB v9 - Feb 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

 Safety Reporting Documents

Instructions for SAE reporting v1 3-Oct-2017

Serious Adverse Event - ARGO SAE SUSAR Report Form v4 10-May-2019

Translational Sample Documents

Tissue Samples Dispatch Log HMDS and WISH v2 22 Aug 2018

Sample Shipment Form for HMDS v2 22 Aug 2018

Sample Shipment Form for Wish Lab v2 22 Aug 2018

Lab Manual v2 29-Nov-2018

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