IELSG-42 Trial

Trial Name:

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:

Primary Endpoint:

1-year progression-free survival (PFS)

Secondary Endpoints:

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

Design:

This was 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.

Status:

Completed.

Population:

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

Publications:

Andrés J M Ferreri, Jeanette K Doorduijn, et al. MATRix-RICE therapy and autologous haematopoietic stem-cell transplantation in diffuse large B-cell lymphoma with secondary CNS involvement (MARIETTA): an international, single-arm, phase 2 trial.?Lancet Haematol, 2021 Feb;8(2):e110-e121. doi: 10.1016/S2352-3026(20)30366-5.