IELSG 42

Title

IELSG 42 - An international phase II trial assessing tolerability and efficacy of sequential Methotrexate-Aracytin-based combination and R-ICE combination, followed by high-dose chemotherapy supported by autologous stem cell transplant, in patients with systemic B-cell lymphoma with central nervous system involvement at diagnosis or relapse (MARIETTA regimen).

Objectives

This is an open, non comparative, multicentre phase II trial, to evaluate the efficacy and feasibility of a new sequential combination of HD-MTX-AraC-based chemoimmunotherapy, followed by R-ICE regimen, and by high-dose chemotherapy supported by ASCT.

Primary Endpoint:

• 1-year progression-free survival (PFS)

Secondary Endpoints:

• Complete remission rate before autologous stem cell transplantation
• Response duration
• Overall survival
• Safety

Trial Status

In follow-up

Population

This is an international trial looking to recruit 76 patients (to include 20 UK patients).

This research is funded by the Stand Up to Cancer campaign for Cancer Research UK (award reference no. C36711/A18805)