ZR-MTX for PIOL Phase II Trial

Sponsor
Peking Union Medical College Hospital
Study ID
NCT06973811
Phase
PHASE2
Status
Recruiting
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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
  • Rituximab (R) — 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
  • Methotrexate (MTX) — DRUG
    Methotrexate 3.5g/m2 intravenous infusion d1, every 21 days for cycle 5 and 6 only.

Study Details

This is a prospective single-arm phase II study, with the purpose of evaluating the efficiency of ZR-MTX regimen (Rituximab, Zanubrutinib and methotrexate) combined with intravitreal methotrexate, then followed by minimal residual disease directed Zanubrutinib maintenance in newly-diagnosed primary intraocular lymphoma. The primary endpoint of this study is progression-free survival (PFS).

Key Dates

First listed
May 15, 2025
Start date
May 21, 2025
Status verified
Aug 2026
Primary completion
Oct 30, 2027
Completion
Oct 30, 2029

Study Design

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

Arms

  • Experimental: ZRMTX
    Zanubrutinib/Rituximab/IV MTX \& intravitreal MTX Experimental arm will be treated with rituximab plus zanubrutinib (ZR) regimen for 4 cycles, ZR plus iv MTX for 2 cytles and followed by zanubrutinib maintenance for 2 years ( or choose to stop zanubrutinib maintenance if reached CR with negative CSF cfDNA). 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