Optimizing MATRix as remission induction in PCNSL: De-escalated induction treatment in newly diagnosed primary CNS lymphoma – a randomized phase III trial.
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.
Primary:
Secondary:
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.
Open to recruitment.
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.
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
Email: optimatetrial@soton.ac.uk
Email: ctu@soton.ac.uk
Phone: 0844 7740621
Essential Trial Documents
OptiMATe - Clinical Trial Protocol v3 18-MAY-2022.pdf
OptiMATe - UK Specific Protocol Appendix v1 31-MAY-2022.pdf
OptiMATe - Patient Information Sheet (Template) v1 29-JUL-2022.docx
OptiMATe - Pregnancy Follow-up Informed Consent Form (Template) v1 13-JUL-2022.docx
OptiMATe - Pregnancy Follow-up Information Sheet (Template) v1 13-JUL-2022.docx
OptiMATe - Informed Consent Form (Template) v1 29-JUL-2022.docx
OptiMATe - Legal Representative (Personal) Consent Form (Template) v1 29-JUL-2022.docx
OptiMATe - Legal Representative (Professional) Consent Form (Template) v1 29-JUL-2022.docx
OptiMATe - Legal Representative Information Sheet (Template) v1 29-JUL-2022.docx
OptiMATe - GP Letter (Template) v1 13-JUL-2022.docx
OptiMATe - Patient Information Card (Template) v1 05-APR-2022.docx
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 (Sponsor) v7 06-MAR-2023
Pharmacy & IMP Documents
OptiMATe - Busilvex 6mg_ml concentrate for solute….pdf
OptiMATe - Carmustine 100mg Powder and solvent for….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
Randomisation and Other Database Related Documents
OptiMATe - 10.1_OPTIMATE_InvestigatorUserManual_final_EN_20221116_signed_.pdf
OptiMATe - Emergency_Randomisation_OptiMATe_Neuropsychological_Testbattery_20221114.pdf
OptiMATe - Emergency_Randomisation_OptiMATe_Treatment_Arm_20221114.pdf
OptiMATe - secuTrial_User_Account_Application_OptiMATe_20221114.pdf
OptiMATe - secuTrial_User_Account_LockOptiMATe20221114_final.pdf
Safety Reporting Documents
Optimate - pregnancy_reporting_form_20210520.pdf
OPTIMATE - PV_Manual_V1_20210520_Final_Sig.pdf
Optimate - SAE-form_20220923_ArmA.pdf
Optimate - SAE-form_20220923_ArmB.pdf
Optimate - SAE-form_20220923_Screening.pdf
OPTIMATE - SAE_Reporting_Manual_V03_20221006.pdf
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
Trail Making Test (TMT) - Part A & Part B.pdf
Press releases, video clips and other external websites:
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