Efficacy of Lenalidomide Maintenance in Primary Central Nervous System Lymphoma and Primary Vitreoretinal Lymphoma: a Phase II, Open-label, Single-arm Study

Study Purpose

Therefore, we intend to conduct a phase II study to evaluate the efficacy of maintenance therapy with lenalidomide as the maintenance therapy for patients with PCNSL or PVRL who have achieved CR or partial response after HD-MTX-based induction therapy followed by reduced-dose WBRT.Twentypatients with PCNSL or PVRL will be recruited. The primary outcome is 2-year progression-free survival from the first date of reduced-dose WBRT. Besides, the safety and the incidence of cute and late neurotoxicity related to reduced-dose WBRT, the single nucleotide polymorphism assay,and the clinical applications of plasma and CSF circulating tumor DNA and CSF lactate level will be investigated.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Those who have been diagnosed with histopathological- or CSF/vitreous fluid flow cytometry- confirmedPCNSL/PVRL, DLBCL subtype and who are above 18 years of age. 2. Those who have completed standard HD-MTX-based remission induction chemotherapy followed by reduced-dose WBRT and reached a CR or PR. 3. Patients must be able to tolerate MRI scans and lumbar punctures and/or Ommaya taps. 4. With sufficient organ and bone marrow function, and no severe hematopoietic, heart, lung, liver, kidney, thyroid dysfunction, and immune deficiency. 5. ECOG PS 0-2. 6. Those who can take oral medication. 7. Written informed consent under institutional guidelines. 8. Female patients of child-bearing potential (FCBP) must have two negative pregnancy tests (sensitivity of at least 25 mIU/mL) prior to starting lenalidomide. The first pregnancy test must be performed within 10 to 14 days prior to the start of lenalidomide, and the second pregnancy test must be performed within 24 hours prior to the start of lenalidomide. 9. Effective method of contraception should be used during and for 28 days following the last dose of the drug. 10. Male patients must use an effective barrier method of contraception during study and 28 days following the last dose if sexually active with a FCBP.

Exclusion Criteria:

1. Patients who are planned to undergo auto-SCT after induction chemotherapy. 2. Disease involving extra-CNSat the time of initial diagnosis. 3. Previous treatment with lenalidomide or WBRT. 4. Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within six months prior to 1st day of 1st cycle. 5. Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents. 6. Known human immunodeficiency (HIV) seropositive. 7. Those who are unable to take oral medication or unable to take antiplatelet therapy for the purpose of thromboembolism prevention. 8. Patients with a history of malignant tumors other than the target diseases except for the following cases oIf the tumor has not been treated for at least 5 years or is disease-free oPatients at least 1 year after complete resection of basal cell carcinoma / squamous cell carcinoma or successful treatment of cervical epithelial cancer. 9. Adverse reactions within 30 days prior to screening Severe gastrointestinal bleeding exceeding Grade 2 according to the Common Terms Criteria 4.03 version criteria. 10. Occurrence of blood clots or embolism within 6 months before starting screening. 11. Patients with hypersensitivity to THIS DRUG and other ingredients of THIS DRUG (e.g., angioedema, Stevens-Jones syndrome, toxic epidermal necrosis, etc.) 12. Female patients who are pregnant or lactating. 13. The Patient is unwell or unable to participate in all required study evaluations and procedures.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05901324
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	National Taiwan University Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Primary Central Nervous System Lymphoma and Primary Vitreoretinal Lymphoma

Arms & Interventions

Arms

Experimental: Maintenance therapy with lenalidomide as the maintenance therapy for patients with PCNSL or PVRL

Interventions

Radiation: - intensity-modulated radiotherapy (IMRT)

1.8 Gy of 4-6 MV X-ray to a total dose of 23.4 Gy (13 fractions) will be delivered.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Chieh Lung Cheng, doctoral degree

Jerome010471@gmail.com

+886972651893

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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