New treatment approach for primary CNS lymphoma using stem cells and nivolumab

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

This study is testing a new treatment plan for people with newly diagnosed primary CNS lymphoma that uses a mix of medications and stem cell transplants to see if it helps them get better and stay in remission.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: National Research Center for Hematology, Russia (Research network)
• Drugs / interventions: chemotherapy, nivolumab, rituximab, methotrexate, cyclophosphamide
• Locations: 1 site (Moscow)
• Trial ID: NCT05425654 on ClinicalTrials.gov

What this trial studies

This study evaluates a new treatment regimen for patients with newly diagnosed primary CNS lymphoma, incorporating a combination of rituximab, methotrexate, procarbazine, vincristine, and lenalidomide as induction therapy. Following this, patients will undergo autologous stem cell transplantation with a conditioning regimen that includes high doses of busulfan, thiotepa, and cyclophosphamide. To prevent early relapses, maintenance therapy with nivolumab will be administered after transplantation. The study aims to assess the efficacy and safety of this innovative approach.

Who should consider this trial

Good fit: Ideal candidates include individuals with non-Hodgkin's lymphoma involving the brain, confirmed by imaging and histology, who meet specific health criteria.

Not a fit: Patients with systemic lymphoma, HIV-1 positive status, or inadequate organ function may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and reduce early relapses in patients with primary CNS lymphoma.

How similar studies have performed: While this approach is innovative, previous studies have shown promising results with similar therapies in treating CNS lymphomas.

Eligibility criteria

Inclusion Criteria:

All patients must have non-Hodgkin's lymphoma involving the brain, as demonstrated by CT or MRI and histologic confirmation by one of the following: A positive CSF cytology for lymphoma or a monoclonal lymphocyte population as defined by cell surface markers.

A biopsy of the vitreous or uvea demonstrating non-Hodgkin's lymphoma. Brain biopsy.

Patients must be HIV-1 negative. Patient must have left ventricular ejection fraction ≥ 50%. Patients must have no evidence of systemic lymphoma. This must be demonstrated by a CT scan of the chest, abdomen and pelvis prior to registration.

Patients must have adequate bone marrow function (defined as peripheral leucocyte count \>3000 cells/mm3 and platelet count \> 100,000 cells/mm3), liver function (bilirubin \< 2.0 mg/%), and adequate renal function (serum creatinine \< 1.5 mg/dl or creatinine clearance \> 50cc/min/1.73M2).

Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.

Patients must be between 18 and 70years-old. Patients must sign an informed consent.

Exclusion Criteria:

Prior cranial irradiation Other active primary malignancy. Pre-existing immunodeficiency such as renal transplant recipient. Prior treatment with chemotherapy for CNS lymphoma.

Where this trial is running

Moscow

• Nathional Medical Research Center for Hematology — Moscow, Russia (Recruiting)

Study contacts

• Study coordinator: Eugene Zvonkov, Phd, MD

Conditions Primary CNS Lymphoma