R2-MTX With Lenalidomide Maintenance in Newly-diagnosed PCNSL a Multicenter Phase Ib/II Stuty

  • STATUS
    Recruiting
  • End date
    Aug 24, 2024
  • participants needed
    47
  • sponsor
    Peking Union Medical College Hospital
Updated on 24 January 2021
methotrexate
rituximab
lenalidomide
nervous

Summary

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.

Description

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-2020the 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-2020Younger 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.

Details
Condition Primary Central Nervous System Lymphoma, Central Nervous System Lymphoma, Primary CNS Lymphoma, cns lymphoma
Treatment Rituximab, methotrexate, Lenalidomide
Clinical Study IdentifierNCT04120350
SponsorPeking Union Medical College Hospital
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have Primary Central Nervous System Lymphoma?
Do you have any of these conditions: cns lymphoma or Central Nervous System Lymphoma or Primary Central Nervous System Lymphoma or Primary CNS Lymphoma?
Newly-diagnosed primary vitreoretinal lymphoma
ECOG2
creatinine clearance rate (CCR) 50ml/h, according to Cockcroft-Gault
Total bilirubin < 2 upper limits of normal, alanine aminotransferaseALT < 3 upper limits of normal
HIV-Ab negative
Sign the Informed consent
Women of childbearing potential must understand that the study medication could have a potential teratogenic risk. They should undergo complete contraception during the study period
Male subjects must agree to use condoms throughout study drug therapy

Exclusion Criteria

Pre-existing uncontrolled active infection
Clinical evidence of grade 3 or 4 heart failure as defined by the New York Heart Association criteria
systemic lymphoma involved CNS
Pregnancy or active lactation
Co-existing tumors
Clear my responses

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