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The University of Southampton
Southampton Clinical Trials Unit

OptiMATe

Trial Overview

Trial Team

Essential Trial Documentation

Other Media

Title

Optimizing MATRix as remission induction in PCNSL: De-escalated induction treatment in newly diagnosed primary CNS lymphoma – a randomized phase III trial.

Description

OptiMATe is a randomised Phase III trial which aims to improve outcomes for people with lymphoma of the brain and spinal cord, for which current treatments are not always successful.

A previous trial (IELSG322) found that a treatment regimen called MATRix, which is a combination of chemotherapy drugs and an immunotherapy treatment called rituximab, followed by a stem cell transplant, could lead to long-term survival for around 70% of people with primary central nervous system lymphoma (PCNSL). This trial led to a change in the standard of care for this disease in the UK and much of Europe.

However, around a third of patients do not respond or relapse following this treatment, and complications are reported to be 11-28% per each cycle of MATRix (most frequently appearing in the first cycles of treatment). The OptiMATe trial will therefore investigate whether MATRix can be optimised by changes to the timings and intensity of how the different drugs are given.

Objectives

Primary:

  • To demonstrate superiority of a de-escalated induction treatment strategy followed by autologous stem cell transplantation compared to the standard MATRix protocol in terms of event free survival (EFS).

Secondary:

  • To compare overall survival, progression free survival, remission rate prior to consolidation and after consolidation, rate of patients reaching consolidation, complication rate, neurocognitive impairment, and quality of life between both treatment arms.

Trial Design

OptiMATe is an international, multi-centre, randomised, open label, phase 3 superiority trial, for patients newly diagnosed with PCNSL. The aim of the trial is to compare 2 different approaches to induction chemotherapy. The standard arm comprises remission induction with 4 cycles of MATRix, followed by HDT-ASCT for responding patients. The experimental arm adopts two changes aimed at optimising remission induction before proceeding to HDT-ASCT. Patients will be followed up for a minimum of 24 months from completion of treatment.

Trial Status

Open to recruitment.

Population

Immunocompetent patients aged 18-65 years (or 66-70 years with an ECOG <2) with newly diagnosed, histologically confirmed PCNSL who are considered eligible for the study treatment at the time of diagnosis.

 

SU2C logo

This research is funded by the Stand Up to Cancer campaign for Cancer Research UK (award reference no. CRCPJT\100010)

Senior Trial Manager

Karen Martin

Trial Manager

Chris Wignall

Medical Statistician

Louise Stanton

Clinical Data Coordinator

Sophie McKenna

 

Contact Information:

Email: [email protected]

 

SAE Reporting:

Email: [email protected]

Phone: 0844 7740621

Essential Trial Documents

OptiMATe - Clinical Trial Protocol v4 EU 17-MAY-2024

OptiMATe - UK Specific Protocol Appendix v2 23-MAY-2024

OptiMATe - Patient Information Sheet (Template) v2 26-FEB-2024

OptiMATe - Pregnancy Follow-up Informed Consent Form (Template) v2 26-Feb-2024

OptiMATe - Pregnancy Follow-up Information Sheet (Template) v2 26-FEB-2024

OptiMATe - Informed Consent Form (Template) v2 26-FEB-2024

OptiMATe - Legal Representative (Personal) Informed Consent Form (Template) v2 26-FEB-2024

OptiMATe - Legal Representative (Professional) Informed Consent Form (Template) v2 26-FEB-2024

OptiMATe - Legal Representative Information Sheet (Template) v2 26-FEB-2024

OptiMATe - GP Letter (Template) v2 26-FEB-2024

OptiMATe - Patient Information Card (Template) v1 05-APR-2022

OptiMATe - Advanced MRI sub-study Informed Consent Form (Template) v1 26-FEB-2024

OptiMATe - Advanced MRI sub-study Patient Information Sheet (Template) v1 26-Feb-2024

 

ISF Documents

OptiMATe - Master Patient List v1 22-NOV-2022.pdf

OptiMATe - Screening Log v1 22-NOIV-2022.pdf

OptiMATe - Site Visit Log v1 17-NOV-2022.pdf

OptiMATe - Site Delegation Log v2 25-JAN-2023.pdf

OptiMATe - Site Training Log v1 21-NOV-2022.pdf

OptiMATe - secuTrial Training Log v2 21-FEB-2023

 

Pharmacy & IMP Documents

OptiMATe - Busilvex 6mg_ml concentrate for solute….pdf

OptiMATe - Carmustine 100mg Powder and solvent for….pdf

OptiMATe - Cytarabine 100mg_ml Solution for injection or infusion - Summary of Product Characteristics (SmPC).pdf

OptiMATe - MabThera 100mg Concentrate for Solutio….pdf

OptiMATe - Methotrexate 100mg_ml solution for inj….pdf

OptiMATe - TEPADINA 100 mg powder for concentrate….pdf

 

Lab Documents

OptiMATe - Lab Manual v1 17-NOV-2022.pdf

OptiMATe - HMDS Tissue Samples Dispatch log v1 08-NOV-2022.pdf

OptiMATe - HMDS Baseline Sample Shipment Form v1 08-NOV-2022.pdf

OptiMATe - HMDS Treatment & Follow-up Sample Shipment Form v1 08-NOV-2022.pdf

 

Imaging Documents

OptiMATe - Imaging Manual, v2 03-Oct-2023

OptiMATe - MRI Scanning Form, v2 03-Oct-2023

OptiMATe - Imaging Dispatch log v1 23-NOV-2022.pdf

OptiMATe - Image Shipping Form - Screening, v2 03-Oct-2023

OptiMATe - Image Shipping Form - Response Assessment, v2 03-Oct-2023

OptiMATe - XNAT Manual v1 21-Mar-2024

 

Randomisation and Other Database Related Documents

OptiMATe - Investigator Manual for secuTrial v3 29-JAN-2024

OptiMATe - Emergency Randomisation Form - Neuropsychological Test Battery v1 14-NOV-2022

OptiMATe - Emergency Randomisation Form - Treatment Arm v1 14-NOV-2022

OptiMATe - secuTrial User Account Application Form - UK v4 06-DEC-2023

OptiMATe - secuTrial User Account Lock­ Form - UK v4 06-DEC-2023

 

Safety Reporting Documents

OptiMATe - Pregnancy Reporting Form v1 20-MAY-2021

OptiMATe - ­Arm A SAE Form­ v2 23-SEP-2022

OptiMATe - ­Arm B SAE Form­ v2 23-SEP-2022

OptiMATe - ­Screening SAE Form­ v2 23-SEP-2022

OptiMATe - SAE Reporting Manual v3 06-OCT-2022

 

Neuropsychological Assessment

OptiMATe - Manual of Test Procedures - Neurocognitive Test Battery Version 1 v2 05-Jul-2023.pdf

OptiMATe - Manual of Test Procedures - Neurocognitive Test Battery Version 2 v2 05-Jul-2023.pdf

OptiMATe - Further explanations of the Neurocognitive Test Battery Version 1 v1 05-Jul-2023.pdf

OptiMATe - Further explanations of the Neurocognitive Test Battery Version 2 v1 05-Jul-2023.pdf

OptiMATe - REC Application 22NW0281 IRAS 1005070 Favourable Opinion.pdf

OptiMATe - Neuropsychological Testing Checklist v1 27-Jul-2023.pdf

MoCA Version 7.1.pdf

MoCA Version 7.2.pdf

MoCA Version 7.3.pdf

Trail Making Test (TMT) - Part A & Part B.pdf

EORTC QLQ-C30.pdf

EORTC QLQ-BN20.pdf

 

Press releases, video clips and other external websites:

(University of Southampton cannot accept responsibility for external websites)

 

OptiMATe trial opening, May 2023

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