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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

ARGO GP letter v3 4 Dec 2017

ARGO Informed Consent Form v7 29-11-2018.docx

ARGO Patient Information Sheet v7 29-Nov-2018.docx

ARGO Protocol v5 05_Mar_2019.pdf

ARGO Pregnant Partner Patient Information Sheet v3 30-May 2018

ARGO Pregnant Partner Informed Consent v3 06-Jun 2018

ISF Documents

2.1 - ARGO Master Patient List v1 12 Sep 2017

2.2 - ARGO - Patient Screening Log v3 26-Apr-2019.doc

3.1 - ARGO Site Delegation Log v1 12 Sep 2017

3.3 - ARGO Staff Training Records v1 12 Sep 2017

14.2 - ARGO Site Visit Log v2 25-Jul-2018 

14.1 - ARGO - Site Set-Up Meeting Presentation v3 1 Apr 2019.pdf

Patient Registration and Randomisation

ARGO_eCRF Completion guidelines for sites v3 21-Jun-2019_signed.pdf

TENALEA User Manual ARGO v1.0 19 Sep 2017

Pharmacy Documents

3.2 ARGO Pharmacy Manual v3 29-Apr-2019.pdf

4.10 ARGO IMP Deviation Form_SRD-0135244_v1.docx

4.11 ARGO - Drug Request Form v2 12 Sep 2017

Atezolizumab_IB_v14_Oct2018 and Addendum_1_Dec2018.pdf

SmPC Gemcitabine 15-Mar-2017.pdf

SmPC Oxaliplatin 2 Jan 2018.pdf

Rituximab_IV_IB_v23_Jul2018.pdf

Rituximab SC IB v9 - February 2018.pdf

7.3 Atezolizumab Accountability Log v1 12 Sep 2017

7.3 Gemcitabine Accountability Log v1 12 Sep 2017

7.3 Oxaliplatin Accountability v1 12 Sep 2017

7.3 Rituximab IV Accountability Log v1 12 Sep 2017

7.3 Rituximab SC Accountability Log v1 12 Sept 2017

Rituximab SC IB v9- preparation reference only not RSI- Feb 2017

4.10 ARGO IMP Administration after Temp Deviation Form SRD_0103347_v6.docx

4.10 ARGO IMP Administration After Use By Date Form SRD-0103346_v7.docx

 Safety Reporting Documents

5.1 Instructions for SAE reporting v1 3 Oct 2017

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

Translational Sample Documents

6.3 ARGO - Tissue Samples Dispatch Log HMDS and WISH v2 22 Aug 2018

6.3 Sample Shipment Form for HMDS v2 22 Aug 2018

6.3 Sample Shipment Form for Wish Lab v2 22 Aug 2018

8.4 ARGO Lab Manual v2 29-Nov-2018.pdf

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