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

Sponsor
Peking Union Medical College Hospital
Study ID
NCT03746223
Phase
PHASE2
Status
Unknown

Conditions

  • Primary Intraocular Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Methotrexate — DRUG
    400ug intravitreal injection every week for 4 doses in the induction phase, every 2 weeks for 2 doses as consolidation, then every month for 10 doses as maintenance
  • Rituximab — DRUG
    Rituximab：375mg/m2 intravenous infusion d1, every 28 days for 1 cycle. 6 cycles will be prescribed as protocol
  • Lenalidomide — DRUG
    25mg Qd, oral , d1-21 in 28-day cycle in the induction phase and maintenance phase.

Study Details

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.

Key Dates

Start date
Nov 15, 2018
Status verified
Nov 2018
Primary completion
Nov 15, 2020
Completion
Oct 15, 2025

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: R2-R/IV-MTX（methotrexate）
    experimental arm will be treated rituximab plus lenalidomide (R2) regimen for 6 cycles and followed by lenalidomide maintenance for 2 years, meanwhile intravitreal methotrexate will be given as protocol

Primary Outcome Measure

2 years progression-free survival [ Time Frame: from the date of treatment to the subject finished his 2 years follow-up phase or the disease relapsed or the death due to lymphoma ]

Central Contacts