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Intravitreal Methotrexate and R2(Rituximab & Lenalidomide) Regimen in Newly-diagnosed Primary Vitreoretinal Lymphoma

Primary Purpose

Primary Intraocular Lymphoma

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Methotrexate

Rituximab

Lenalidomide

About this trial

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

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（human immunodeficiency virus） or HBV（hepatitis B virus） or HCV（hepatitis C virus） infection

Sites / Locations

Peking Union medical college hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

R2-R/IV-MTX（methotrexate）

Arm Description

experimental arm will be treated rituximab plus lenalidomide (R2) regimen for 6 cycles and followed by lenalidomide maintenance for 2 years, meanwhile intravitreal methotrexate will be given as protocol

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

NCT ID

NCT03746223

First Posted

November 6, 2018

Last Updated

October 7, 2019

Sponsor

Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03746223

Brief Title

Intravitreal Methotrexate and R2(Rituximab & Lenalidomide) Regimen in Newly-diagnosed Primary Vitreoretinal Lymphoma

Official Title

Combined Intravitreal Methotrexate and R2 Regimen Followed by Lenalidomide Maintenance in Newly-diagnosed Primary Vitreoretinal Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Recruiting

Study Start Date

November 15, 2018 (Actual)

Primary Completion Date

November 15, 2020 (Anticipated)

Study Completion Date

October 15, 2025 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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 R2 regimen (rituximab & lenalidomide) combined with intravitreal methotrexate and followed by lenalidomide 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 R2 regimen （Rituximab 375mg/m2 IV d1, lenalidomide 25mg d1-21, 28 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 R2 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 lenalidomide 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 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 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 Intraocular Lymphoma

Keywords

intravitreal methotrexate injection, rituximab, lenalidomide, Primary vitreoretinal lymphoma

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

R2-R/IV-MTX（methotrexate）

Arm Type

Experimental

Arm Description

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 as maintenance

Intervention Type

Drug

Intervention Name(s)

Rituximab

Intervention Description

Rituximab：375mg/m2 intravenous infusion d1, every 28 days for 1 cycle. 6 cycles will be prescribed as protocol

Intervention Type

Drug

Intervention Name(s)

Lenalidomide

Intervention Description

25mg Qd, oral , d1-21 in 28-day cycle in the induction phase and 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 28 days).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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（human immunodeficiency virus） or HBV（hepatitis B virus） or HCV（hepatitis C virus） infection

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wei Zhang, MD

Phone

+86 136 8147 3557

vv1223@vip.sina.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yan Zhang, MD

Phone

+86 13810000485

zhangyan10659@pumch.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daobin Zhou, MD

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Principal Investigator

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

Wei Zhang

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34249763

Citation

Zhang Y, Zhang X, Zou D, Yin J, Zhang L, Wang X, Jia C, Wang W, Zhao D, Zhou D, Zhang W, Zhang M. Lenalidomide and Rituximab Regimen Combined With Intravitreal Methotrexate Followed by Lenalidomide Maintenance for Primary Vitreoretinal Lymphoma: A Prospective Phase II Study. Front Oncol. 2021 Jun 24;11:701507. doi: 10.3389/fonc.2021.701507. eCollection 2021.

Results Reference

derived

Learn more about this trial

Intravitreal Methotrexate and R2(Rituximab & Lenalidomide) Regimen in Newly-diagnosed Primary Vitreoretinal Lymphoma

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