RecruitingPhase 2NCT05260619

Lenalidomide Maintenance Treatment in Patients With Primary Central Nervous System Lymphoma

Phase II Trial of Lenalidomide Maintenance After High-dose Methotrexate-based Immunochemotherapy in Patients With Primary Central Nervous System Lymphoma

Sponsor

Seoul National University Bundang Hospital

Enrollment

28 participants

Start Date

Apr 1, 2022

Study Type

INTERVENTIONAL

Conditions

Central Nervous System Lymphoma

Summary

The study will include 28 patients with primary CNS DLBCL who are ineligible with autologous hematopoietic stem cell transplantation or whole brain radiation therapy as consolidation therapy. Induction treatment will include Rituximab and high dose methotrexate protocol (containing at least methotrexate and one more chemotherapy agent). Patients with MRI documented response CR or PR after induction chemotherapy will enter the study protocol of lenalidomide maintenance (at a dose of 15 mg per day, on days 1 to 21 of each 28-day cycle) for a maximum of 12 cycles, withdrew consent, the disease progressed, or unacceptable toxic effects occurred.

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether lenalidomide (a type of immune-modulating cancer drug) can help prevent lymphoma from coming back in patients with primary central nervous system lymphoma (PCNSL) — a type of lymphoma that grows inside the brain — after they have completed their initial treatment. **You may be eligible if...** - You have been diagnosed with primary CNS lymphoma (confirmed by biopsy) - Your cancer responded to your initial treatment (complete or partial remission) - You have adequate blood counts and organ function - Your ECOG performance status is 0, 1, or 2 - You are willing to follow strict pregnancy prevention requirements (for women of childbearing potential) **You may NOT be eligible if...** - Your lymphoma has not responded to first-line treatment - You have severely reduced kidney function - You have had a prior blood clot while on lenalidomide - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGlenalidomide

Patients with MRI documented response CR or PR after induction chemotherapy will enter the study protocol of lenalidomide maintenance (at a dose of 15 mg per day, on days 1 to 21 of each 28-day cycle) for up to 12 cycles or until the patients withdrew consent, the disease progressed, or unacceptable toxic effects occurred.