Primary Central Nervous System Lymphoma Clinical Trial
Official title:
R2-MTX Regimen Combined With Lenalidomide Maintenance as Frontline Therapy for Primary Central Nervous System Lymphoma: a Multicenter Prospective Single Arm Trial.
This is a multicenter prospective single arm phase Ib/II study, and the purpose of this study is to evaluate the safety and efficiency of R2-MTX regimen (rituximab & lenalidomide & methotrexate) combined with lenalidomide maintenance in newly-diagnosed primary central nervous system lymphoma. 2-year Progression free survival (PFS) of the cohort is the primary endpoint.
There are 2 section of this trial. Step1 is a phase Ib study.The patients will be treated
with R2-MTX regimen （Rituximab 375mg/m2 IV d0, methotrexate 3.5g/m2 civ d1, lenalidomide
15-25mg d1-14, 21 days per cycle) as induction regimen.The dose of rituximab and methotrexate
is fixed dose. This is a 3+3 design Ib phase dose-escalation study to determined the maximum
tolerated dose(MTD) of lenalidomide dose in combined regimen. 3 levels of lenalidomide dose
will be investigated, 15mg, 20mg and 25mg. If the DLT is not found, the dose of 25mg qd will
be used for phase II trial.
[update 02-Jun-2020：the recommended phase II doses is 25mg d1-14]
Step 2 is a single-arm phase 2 study with fixed does of R2-MTX regimen in newly-diagnosed
PCNSL patients. The response will be evaluated every 2 cycles. Patients who achieved complete
remission (CR) or partial remission (PR) will receive further treatment, and there are 6
cycles of R2-MTX regimen for the induction. The patients with stable disease (SD) or
progressed disease (PD) will withdraw from the trial and receive salvage regimens. After
total 6 induction cycles, the investigators evaluate the efficiency again, the patients with
CR or PR will go to lenalidomide maintenance for 2 years or until progression of the disease
(PD), unacceptable toxicity, or patient/investigator discretion. And the patients with SD or
PD will receive salvage regimen.
[update 02-Jun-2020：Younger patients(≤60 years) who achieve PR after 6 cycles of induction
therapy will be candidates of high-dose chemotherapy and stem cell rescue. Lenalidomide
maintenance will be administed after the high-dose chemotherapy. Older patients(>60 years)
who achieve PR after 6 cycles of induction will go to lenalidomide maintenance directly.]
During following-up, surveillance examination and brain magnetic resonance imaging (MRI)
scans can be performed every 3 months up to the first 2 years, followed by doctor visit every
6 months up to 5 years or the disease relapses.
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