Study objectives and endpoints
death, Tumor, RA
DISEASE PROGRESSION, TUMOR, EVENT, REMISSION, LYMPHOMA
The primary objective of this trial is to demonstrate superiority (in terms of PFS) of a shorter but more intensive treatment regimen comprising 2 cycles of MARTA (R-MTX/AraC) followed by busulfan and thiotepa-based HCT-ASCT, compared to standard treatment with R-MP and procarbazine maintenance. The primary endpoint PFS is defined as time from randomization to disease progression or death of any cause, with censoring at the last date the patient was seen alive and free of disease progression.Secondary efficacy endpoints are OS, event free survival (EFS), defined as time from randomization to premature EOT due to any reason, lymphoma progression or death, whichever occurs first, censoring at the last date the patient was seen event-free, remission rate (complete remission (CR) and partial remission (PR)) after 2 cycles of R-MP (arm A) / 2 cycles of MARTA prior to consolidation treatment (arm B) (measured at response assessment (RA) I) and after 3 cycles of R-MP (arm A) / after HCT-ASCT (arm B) (measured at RA II). Tumor response will be assessed by gadolinium-enhanced brain MRI according to the IPCG response criteria [