RecruitingPhase 2NCT05425654

RL-MPV Followed by BBC HCT Using Autologous Stem Cells and Maintenance Therapy With Nivolumab for Newly Diagnosed PCNSL

Rituximab, Methotrexate, Procarbazine, Vincristine, Lenalidomide (RL-MPV) Followed by BBC (BCNU, Busulfan, Cyclophosphamide) High-dose Chemotherapy With Auto-HCT and Maintenance Therapy With Nivolumab in Newly Diagnosed Primary CNS Lymphoma

Sponsor

National Research Center for Hematology, Russia

Enrollment

30 participants

Start Date

May 17, 2021

Study Type

INTERVENTIONAL

Conditions

Primary CNS Lymphoma

Summary

The purpose of this study is to determine the efficacy and safety of the new treatment proposed in this study. Conducting a prospective study "CNS-2015" in patients with PDLBCL CNS made it possible to achieve 2-year EFS, DFS and OS of 83%, 83% and 88%, respectively. The presence of early relapses of the disease has now led to the need to find an alternative program for patients with PDLBCL CNS. In the new "CNS-2021" protocol, lenalidomide was included in the R-MPV program in order to intensify the induction stage. In the conditioning regimen, thiotepa was replaced by carmustine, due to its significant CNS bioavailability. In order to possibly prevent early relapses, an anti-PD-1 inhibitor (nivolumab) was used as maintenance therapy.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment plan for primary central nervous system lymphoma (PCNSL) — a rare type of lymphoma that affects only the brain and eye. The approach uses a combination of chemotherapy, an autologous stem cell transplant (using your own stem cells), and a maintenance immunotherapy drug (nivolumab). **You may be eligible if:** - You are between 18 and 70 years old - You have newly diagnosed non-Hodgkin's lymphoma involving only the brain (confirmed by MRI or biopsy) - Your heart function is adequate (ejection fraction ≥50%) - Your blood counts, liver, and kidney function are within normal ranges - You test negative for HIV - You agree to use contraception during and for 6 months after treatment **You may NOT be eligible if:** - You have previously had brain radiation - You have another active cancer - You have a pre-existing immune deficiency (e.g., from a transplant) - You have previously received chemotherapy for CNS lymphoma - Your lymphoma has spread beyond the brain and eye 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, Methotrexate, Vincristine, Procarbazine, Lenalidomide

The initial treatment will consist of cycles of 14 days. Each cycle will start with rituximab, which will be given by vein on day 1. On day 2 you will receive: Methotrexate will be given by vein over 2 to 3 hours and vincristine will be given as a single injection over a few minutes. Procarbazine and Lenalidomide are a pill that you will take at bedtime for 7 nights starting on day 2. Procarbazine and Lenalidomide are only given every other cycle. During each cycle, you will be in the hospital. After the second cycle of chemotherapy, PBPCs will be collected. You will be hospitalized again for high-dose chemotherapy and receive supportive medications to help avoid complications, including antibiotics and blood transfusions. Busulfan, carmustine and cyclophosphamide will be given to you for 5 days. After break of 1 day, we will return your PBPC (or bone marrow) to you through a vein. You will be in the hospital for at least 3 weeks.