Intravitreal MTX and ZR Regimen in Newly Diagnosed PVRL

Sponsor
Peking Union Medical College Hospital
Study ID
NCT04899453
Phase
PHASE2
Status
Unknown

Conditions

  • Primary Vitreoretinal 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
  • Rituximab — DRUG
    Rituximab 375mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 6 cycles will be prescribed as protocol
  • Zanubrutinib — DRUG
    160mg Bid, oral. 21-day cycle for 6 cycles in the induction phase and for 2 years in the 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 ZR regimen (rituximab \& Zanubrutinib) combined with intravitreal methotrexate and followed by Zanubrutinib maintenance in newly-diagnosed primary intraocular lymphoma. Progression-free survival (PFS) of the cohort is the primary endpoint.

Key Dates

Start date
Aug 1, 2020
Status verified
May 2021
Primary completion
Aug 1, 2022
Completion
Aug 1, 2024

Study Design

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

Arms

  • Experimental: Zanubrutinib/rituximab & intravitreal MTX
    Experimental arm will be treated with rituximab plus zanubrutinib (ZR) regimen for 6 cycles and followed by zanubrutinib maintenance for 2 years, meanwhile, intravitreal methotrexate will be given as protocol during the 1st year of treatment.

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

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