This phase III study investigates if a de-escalated induction treatment in newly diagnosed primary CNS lymphoma is superior to the standard MATRix protocol in terms of event free survival.
This phase III study investigates if a de-escalated induction treatment in newly diagnosed primary CNS lymphoma is superior to the standard MATRix protocol in terms of event free survival. Two arms are compared, in the experimental treatment group, participants receive one course of R/HD-MTX, followed by two courses of MATRix and autologous stem cell transplantation. In the control treatment, participants receive four coourses of MATRix followed by autologous stem cell transplantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
326
De-escalated induction treatment with R/HD-MTX and two courses of MATRix
Patients receive four courses of MATRix as induction treatment.
Klinikum Stuttgart
Stuttgart, Baden-Wurttemberg, Germany
RECRUITINGEvent-free survival (EFS)
time from randomization to premature end of treatment due to any reason, lymphoma progression or death, whichever occurs first
Time frame: up to 24 months after end of treatment
Overall survival (OS)
time from randomization to death of any course
Time frame: up to 24 months after end of treatment
Progression free survival (PFS)
time from randomization until disease progression, relapse or death from any cause
Time frame: up to 24 months after end of treatment
Remission rate prior to consolidation therapy
Remission prior to consolidation therapy will be determined at RA II and will be divided in CR, uCR, PR, CD, PD according to IPCG criteria
Time frame: assesed at RA II (Arm B: day 18-20 of cycle 2, each cycle is 21 days. Arm A: day 18-20 of cycle 4, each cycle is 21 days)
Remission rate after consolidation therapy
Remission after consolidation therapy will be determined on day 30 after ASCT and will be divided in CR, uCR, PR, SD, PD according to IPCG criteria
Time frame: 30 days after ASCT
rate of patients reaching consolidation therapy
defined as obtaining at least the first dose of consolidation therapy, will be determined after the response assessment II (following 4 cycles of MATRix in the control arm and following 1 cycle of R/HD-MTX and 2 cycles of MATRix in the experimental arm)
Time frame: determined up to 4 weeks after response assessment II
Quality of life (QOL), EORTC QLQ-C30,
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EORTC (European Organization for research and cancer treatment) QLQ-C30, measured during screening, at response assessment II, and with beginning of RA III every 12 months until end of follow-up
Time frame: up to 24 months after end of treatment
Quality of life (QOL), QLQ-BN20
EORTC (European Organization for research and cancer treatment) QLQ-BN20; measured during screening, at response assessment II, and with beginning of RA III every 12 months until end of follow-up
Time frame: up to 24 months after end of treatment