OptiMATe
Research type
Research Study
Full title
Optimizing MATRix as remission induction in PCNSL: De-escalated induction treatment in newly diagnosed primary CNS lymphoma - a randomized phase III trial.
IRAS ID
1005070
Contact name
Christopher Fox
Contact email
Sponsor organisation
Klinikum der Landeshauptstadt Stuttgart gKAöR
Eudract number
2018-002115-96
Clinicaltrials.gov Identifier
Research summary
Primary diffuse large B-cell lymphoma of the central nervous system (PCNSL) is a rare disorder that may affect one or
several areas of the brain, spinal cord or eye. Current standard of care treatment for newly diagnosed PCNSL patients
aged under 70 is 4 cycles of MATRix (induction treatment), which consists of rituximab, cytarabine, methotrexate and
thiotepa. This is followed by thiotepa-based high-dose chemotherapy with carmustine or busulfan, then autologous
stem cell transplantation (ASCT) (consolidation treatment). The induction treatment is more intensive than some
patients can tolerate, resulting in a third of patients unable to have an ASCT, an important part of successful treatment.
This study aims to increase the number of patients that receive ASCT by reducing the toxicity of induction treatment,
whilst also improving its effectiveness. Newly diagnosed PCNSL patients will be approached for this study. If eligible,
they will be randomised in a 1:1 ratio between standard of care treatment (control arm) and the experimental arm. The
experimental arm consists of one cycle of rituximab and methotrexate, two MATRix drugs that are less toxic. The
hypothesis is that this will allow patients to partially recover after their diagnosis so that they are able to better
withstand subsequent treatment with MATRix. Patients will then receive abbreviated treatment with 2 cycles of MATRix,
then continue to standard of care consolidation treatment. The treatment period is 12 and 16 weeks for the
experimental and control arm, respectively. Patients will be followed up to monitor their response to the treatment for a
minimum of 2 years after transplant.
There is a translational aspect of the study that aims to analyse tumour biopsy samples and blood to try and identify
patients who may be at higher risk of their lymphoma not responding to treatment or returning after treatment has
finished.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
22/NW/0281
Date of REC Opinion
16 Sep 2022
REC opinion
Further Information Favourable Opinion