Intravitreal Methotrexate and R2(Rituximab & Lenalidomide) Regimen in Newly-diagnosed Primary Vitreoretinal Lymphoma

  • STATUS
    Recruiting
  • End date
    Oct 15, 2025
  • participants needed
    42
  • sponsor
    Peking Union Medical College Hospital
Updated on 23 January 2021

Summary

This is a prospective single arm phase II study, and the purpose of this study is to evaluate the efficiency of R2 regimen (rituximab & lenalidomide) combined with intravitreal methotrexate and followed by lenalidomide maintenance in newly-diagnosed primary intraocular lymphoma. Progression free survival (PFS) of the cohort is the primary endpoint.

Description

All the patients will be treated with R2 regimen Rituximab 375mg/m2 IV d1, lenalidomide 25mg d1-21, 28 days per cycle) as induction regimen, meanwhile intravitreal methotrexate was given at a dose of 400ug for 16 doses.

The response will be evaluated every 3 cycles. After 3 Cycles, patients who achieved complete remission (CR) or partial remission (PR) will receive 3 more cycles of R2 regimen. 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.

During following-up, surveillance ophthalmologic 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 Intraocular Lymphoma
Treatment Rituximab, methotrexate, Lenalidomide
Clinical Study IdentifierNCT03746223
SponsorPeking Union Medical College Hospital
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Newly-diagnosed primary vitreoretinal lymphoma
ECOG2
creatinine clearance rate (CCR) 60ml/h, according to Cockcroft-Gault
Total bilirubin < 2 upper limits of normal, alanine aminotransferaseALT < 3 upper limits of normal
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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

primary central nervous system lymphoma involved eyes and brain
systemic B cell lymphoma involved eyes
Pre-existing uncontrolled active infection
Clinical evidence of grade 3 or 4 heart failure as defined by the New York Heart Association criteria
Pregnancy or active lactation
Co-existing tumors
HIVhuman immunodeficiency virus or HBVhepatitis B virus or HCVhepatitis C virus infection
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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