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

Primary Intraocular Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03746223
• Other study ID #: PUMCH-NHL-003
• Status: Recruiting
• Phase: Phase 2
• Start date: November 15, 2018
• Est. completion date: October 15, 2025

Study information

• Verified date: November 2018
• Source: Peking Union Medical College Hospital
• Contact: Wei Zhang, MD
• Phone: +86 136 8147 3557
• Email: vv1223[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: October 15, 2025
• Est. primary completion date: November 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Intraocular Lymphoma
• Lymphoma
• Primary Intraocular Lymphoma

Intervention

Drug:
• Methotrexate
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
• Rituximab
Rituximab:375mg/m2 intravenous infusion d1, every 28 days for 1 cycle. 6 cycles will be prescribed as protocol
• Lenalidomide
25mg Qd, oral , d1-21 in 28-day cycle in the induction phase and maintenance phase.

Locations

Country	Name	City	State
China	Peking Union medical college hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	overall response rate(ORR)	ORR was calculated by the proportion of patients who achieved complete remission and partial remission.	4 weeks after the end of 6 cycles of induction (each cycle is 28 days).