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Intravitreal MTX and ZR Regimen in Newly Diagnosed PVRL

Primary Purpose

Primary Vitreoretinal Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Methotrexate
Rituximab
Zanubrutinib
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Vitreoretinal Lymphoma focused on measuring intravitreal methotrexate injection, rituximab, Primary vitreoretinal lymphoma, zanubrutinib

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zanubrutinib/rituximab & intravitreal MTX

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

overall response rate (ORR)
ORR was calculated by the proportion of patients who achieved complete remission and partial remission

Full Information

First Posted
May 19, 2021
Last Updated
May 19, 2021
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04899453
Brief Title
Intravitreal MTX and ZR Regimen in Newly Diagnosed PVRL
Official Title
Combined Intravitreal Methotrexate and ZR (Zanubrutinib& Rituximab) Regimen Followed by Zanubrutinib Maintenance in Newly-diagnosed Primary Vitreoretinal Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
All the patients will be treated with ZR regimen (Rituximab 375mg/m2 IV d1, Zanubrutinib 160mg Bid, 21 days per cycle) as induction regimen, meanwhile intravitreal methotrexate was given at a dose of 400ug for 16 doses. The response will be evaluated every 3 cycles. After 3 Cycles, patients who achieved complete remission (CR) or partial remission (PR) will receive 3 more cycles of ZR regimen. The patients with stable disease (SD) or progressed disease (PD) will withdraw from the trial and receive salvage regimens. After total 6 induction cycles, the investigators evaluate the efficiency again, the patients with CR or PR will go to Zanubrutinib maintenance for 2 years or until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion. And the patients with SD or PD will receive a salvage regimen. During following-up, surveillance ophthalmologic examination, and brain magnetic resonance imaging (MRI) scans can be performed every 3 months up to the first 2 years, followed by the doctor visit every 6 months up to 5 years or the disease relapses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Vitreoretinal Lymphoma
Keywords
intravitreal methotrexate injection, rituximab, Primary vitreoretinal lymphoma, zanubrutinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zanubrutinib/rituximab & intravitreal MTX
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Rituximab 375mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 6 cycles will be prescribed as protocol
Intervention Type
Drug
Intervention Name(s)
Zanubrutinib
Intervention Description
160mg Bid, oral. 21-day cycle for 6 cycles in the induction phase and for 2 years in the maintenance phase
Primary Outcome Measure Information:
Title
2 years progression-free survival
Description
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 Outcome Measure Information:
Title
overall response rate (ORR)
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Zhang, M.D.
Phone
+8613810000485
Email
zhangyan10659@pumch.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Zhang, M.M.
Phone
13681473557
Email
vv1223@vip.sina.com
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Xu
Phone
+861069156874
Email
pumchkyc@126.com

12. IPD Sharing Statement

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Intravitreal MTX and ZR Regimen in Newly Diagnosed PVRL

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