NCT04899453

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 24, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

May 24, 2021

Status Verified

May 1, 2021

Enrollment Period

2 years

First QC Date

May 19, 2021

Last Update Submit

May 19, 2021

Conditions

Primary Vitreoretinal Lymphoma

Keywords

intravitreal methotrexate injectionrituximabPrimary vitreoretinal lymphomazanubrutinib

Outcome Measures

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

    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)

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

Study Arms (1)

Zanubrutinib/rituximab & intravitreal MTX

EXPERIMENTAL

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.

Drug: MethotrexateDrug: RituximabDrug: Zanubrutinib

Interventions

MethotrexateDRUG

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

Zanubrutinib/rituximab & intravitreal MTX
RituximabDRUG

Rituximab 375mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 6 cycles will be prescribed as protocol

Zanubrutinib/rituximab & intravitreal MTX
ZanubrutinibDRUG

160mg Bid, oral. 21-day cycle for 6 cycles in the induction phase and for 2 years in the maintenance phase

Zanubrutinib/rituximab & intravitreal MTX

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Sign the Informed consent
  • 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.

You may not qualify if:

  • 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
  • HIV or HBV or HCV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Interventions

MethotrexateRituximabzanubrutinib

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Yan Zhang, M.D.

CONTACT

+8613810000485zhangyan10659@pumch.cn

Wei Zhang, M.M.

CONTACT

13681473557vv1223@vip.sina.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2021

First Posted

May 24, 2021

Study Start

August 1, 2020

Primary Completion

August 1, 2022

Study Completion

August 1, 2024

Last Updated

May 24, 2021

Record last verified: 2021-05

Locations

CN(1)