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

NCT03746223 | Unknown Phase 2

• 1 other identifier: PUMCH-NHL-003
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Intraocular Lymphoma

Keywords

intravitreal methotrexate injection; rituximab; lenalidomide; Primary vitreoretinal lymphoma

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 28 days).

Study Arms (1)

R2-R/IV-MTX（methotrexate）

EXPERIMENTAL

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

Drug: Methotrexate; Drug: Rituximab; Drug: Lenalidomide

Interventions

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 as maintenance

R2-R/IV-MTX（methotrexate）

Rituximab DRUG

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

R2-R/IV-MTX（methotrexate）

Lenalidomide DRUG

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

R2-R/IV-MTX（methotrexate）

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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（human immunodeficiency virus） or HBV（hepatitis B virus） or HCV（hepatitis C virus） infection

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union medical college hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 34249763 DERIVED

MeSH Terms

Conditions

Intraocular Lymphoma

Interventions

Methotrexate; Rituximab; Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Eye Neoplasms; Neoplasms by Site; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Isoindoles

Study Officials

• Daobin Zhou, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Zhang, MD

CONTACT

+86 136 8147 3557; vv1223@vip.sina.com

Yan Zhang, MD

CONTACT

+86 13810000485; zhangyan10659@pumch.cn

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: November 6, 2018
• First Posted: November 19, 2018
• Study Start: November 15, 2018
• Primary Completion: November 15, 2020
• Study Completion: October 15, 2025
• Last Updated: October 9, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)