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ZR-MTX for PIOL Phase II Trial

ConditionPrimary Intraocular Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking Union Medical College Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• Newly-diagnosed primary vitreoretinal lymphoma

ECOG≤2

creatinine clearance rate (CCR) ≥ 60ml/h, according to Cockcroft-Gault

Total bilirubin # 2 upper limits of normal, alanine aminotransferase#ALT# < 3 upper limits of normal

Disqualifiers

• 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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

47 Participants
are divided into 1 treatment group
Group A: ZRMTXExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

2 years progression-free survival

2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow up without relapsing

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

Secondary outcomes

1

overall response rate (ORR)

ORR was calculated by the proportion of patients who achieved complete remission and partial remission.

Time frame
4 weeks after the end of 6 cycles of induction (each cycle is 21 days).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College Hospital

Lead sponsor

Source ClinicalTrials.gov
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