RecruitingPhase 2NCT04627753

Study of Lenalidomide/Rituximab Maintenance for Transplantation Ineligible Patients With PCNSL.

Phase II Study of Lenalidomide/Rituximab Maintenance for Transplantation Ineligible Patients With Primary CNS Diffuse Large B-cell Lymphoma (Nickname: Lemon-C Study)


Sponsor

Kim, Seok Jin

Enrollment

30 participants

Start Date

Nov 2, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

* After standard treatment of primary central nervous system lymphoma (PCNSL), high-dose methotrexate induction therapy, and consolidation therapy, most patients reach complete remission, but within the first 6 months, 35-60% of patients refractory to treatment or experience relapse during the first treatment. * The progression-free survival (PFS) period of relapsed patients is 2.2 months (0-29.6 months), and the survival period is reported as 3.5 months (0-29.6 months). After relapse, the majority of patients die within 2-4 months due to neurologic deterioration * Consolidation therapy after induction therapy includes whole-brain radiation therapy, high-dose chemotherapy followed by autologous hematopoietic stem cell transplantation (auto-SCT), and high-dose chemotherapy alone. * However, the median age of the inducing patient is 65 years, and more than half of the patients who are unable to transplant autologous hematopoietic stem cells (auto-SCT) after induction therapy account for more than half. * Therefore, we intend to conduct a study to evaluate the efficacy and safety of maintenance therapy for rituximab and lenalidomide as one of the consolidation therapies for patients with primary central nervous system lymphoma (PCNSL).


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a maintenance therapy — using lenalidomide and rituximab — for patients with primary central nervous system lymphoma (PCNSL, a brain lymphoma) who responded to initial chemotherapy but cannot undergo a stem cell transplant. The goal is to keep the cancer in remission for as long as possible. **You may be eligible if...** - You have been diagnosed with PCNSL and completed standard induction chemotherapy with a complete or partial response - You are ineligible for stem cell transplant — either because you are 65 or older, in fragile health, or you declined transplant - Your blood counts are in an acceptable range - You are able to swallow oral medication - Your liver, kidney, and organ function are within normal limits - Female patients of childbearing age must have two negative pregnancy tests **You may NOT be eligible if...** - You have not responded to induction chemotherapy - You are pregnant or unwilling to use contraception - Your organ function is significantly impaired 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

DRUGRituximab, lenalidomide

Maintenance for 2 years


Locations(1)

Samsung Medical Center

Seoul, South Korea

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NCT04627753


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