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The University of Southampton
Southampton Clinical Trials Unit

RiVa

Title

 RiVa - A phase IIa study of Rituximab and Varlilumab in relapsed or refractory B-cell malignancies

Description

RiVa is a phase IIA clinical trial that evaluates the safety and efficacy of combining a direct tumour targeting antibody (rituximab) with a immunostimulatory antibody (varlilumab) for the treatment of patients with relapsed or treatment-refractory B-cell lymphoma. 

Objectives

Primary Objectives:

  • To document safety and tolerability of combined rituximab and varlilumab therapy.
  • To document anti-tumour activity of combined rituximab and varlilumab therapy in relapsed or refractory B-cell

Secondary Objective:

  • To measure the duration of response to rituximab and varlilumab over a follow-up period of 1 year.

Tertiary Objective:

  • To assess the level of B-cell depletion in the peripheral blood and, where relevant, tumour site following therapy.
  • To establish the proportion of immune effector cell populations in the peripheral blood and, where relevant, tumour site following therapy.
  • To assess whether the expression of CD27 is associated with response in combined rituximab and varlilumab therapy.
  • To ascertain whether co-administration of rituximab and varlilumab alters their pharmacokinetic properties.

Trial Design

This is a multicentre, randomised phase IIa trial in participants with relapsed or refractory CD20+B cell malignancies aiming to recruit 40 participants in total, with 20 participants in each of the following subcategories and 10 per treatment arm:

  • Arm A - High grade lymphoma (DLBCL, FL grade 3b, transformed FL) (n=20)
  • Arm B - Low grade lymphoma (e.g. FL grade 1, 2 or 3a, MZL, MCL, LPL) (n=20)

The trial will include a safety run in where 6-12 participants will be treated and the number of patients with dose limiting toxicities (DLTs) assessed. The trial will only progress to 40 participants if there are an acceptable number of DLTs in this safety run in.

Trial Status

Open to recruitment

Population

The study aims to recurit 40 Patients aged ≥16 years with relapsed or refractory B-cell lymphoma. 

Trial Team:

Senior Trial Manager:

Josh Caddy (023 8120 5537)

Trial Manager:

Katy Mercer (023 8120 3509)

Clinical Data Coordinator:

Zoe Konn (023 8120 5677)

Contact information

Email: riva@soton.ac.uk

Fax: 0844 7740 621

SAE Reporting: ctu@soton.ac.uk or 0844 7740 621

Essential Trial Documents

RiVa Protocol v5 11-Feb-2019.pdf

RiVa - GP letter v2 28-Jul-2017

RiVa Patient Information Sheet v5, 08-Jan-2019.docx

RiVa Consent Form v5 08-Jan-2019.docx

RiVa - Biopsy Patient Information Sheet v3 24-May-2018

RiVa - Biopsy Consent Form v1 08-Jan-2018

RiVa - Pregnancy Consent Form v2 24-May-2018

RiVa - Pregnant Partner Information Sheet v3 24-May-2018

ISF documents

RiVa - Master Patient List v1 19-Jul-2017

RiVa - Patient Screening Log v1 19-Jul-2017

RiVa- Site Visit Log v1 21-Jul-2017

RiVa - Site Delegation Log v1 19-Jul-2017

RiVa - Documentation of Consent Form v1 13-Sep-2017

RiVa Site Training Record v2 15-May-2019.pdf

Translational sample documents

RiVa - Laboratory Manual v1 13-Oct-2017

RiVa - Sampling Worksheet - Core Biopsies v1 13-Oct-2017

RiVa - Sampling Worksheet - Lithium Heparin Samples v1 13-Oct-2017

RiVa - Sampling Worksheet - PK Samples v1 13-Oct-2017

IMP documents

RiVa - Pharmacy Manual v2 25-Sep-2017

RiVa - Varlilumab Drug Order Form v1 18-Aug-2017

RiVa - Varlilumab Accountability Log v1 13-Sep-2017

RiVa - Varlilumab Dispensing Log v1 13-Sep-2017

RiVa - Rituximab Dispensing Log v1 18-Oct-2017

RiVa - CDX-1127_InvestBrochure_v7_24Jan2019.pdf

Safety reporting documents

RiVa - Instructions for completion of Serious Adverse Event Reporting v1 22-Aug-2017

RiVa - Serious Adverse Event - SUSAR Report Form v1 13-Sep-2017

RiVa - Section E Continuation - SAE SUSAR Report Form v1 13-Sep-2017

RiVa - SAE - SUSAR Follow-up Form v1 13-Sep-2017

Patient registration and randomisation

Link to RAVE database (patient registration and eCRF completion): https://login.imedidata.com/login

RiVa - eCRF Completion Guidelines for Sites v2 15-Apr-2019

Link to Tenalea (randomisation): https://prod.tenalea.net/stn/dm/

RiVa - TENALEA User Manual v1 29-Sep-2017

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