Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma

Conditions

• Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bone Marrow Aspiration and Biopsy — PROCEDURE
  Undergo bone marrow aspirate and biopsy
• Computed Tomography — PROCEDURE
  Undergo CT and PET/CT
• Echocardiography Test — PROCEDURE
  Undergo ECHO
• Lenalidomide — DRUG
  Given PO
• Lumbar Puncture — PROCEDURE
  Undergo lumbar puncture
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Methotrexate — DRUG
  Given IV or PO
• Nivolumab — BIOLOGICAL
  Given IV
• Positron Emission Tomography — PROCEDURE
  Undergo PET/CT
• Rituximab — BIOLOGICAL
  Given IV
• Ultrasound Imaging — PROCEDURE
  Undergo testicular ultrasound

Study Details

This phase I trial tests the safety, side effects, best dose and effectiveness of lenalidomide when added to nivolumab and the usual drugs (rituximab and methotrexate) in patients with primary central nervous system (CNS) lymphoma. Lenalidomide may stop or slow primary CNS lymphoma by blocking the growth of new blood vessels necessary for tumor growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Methotrexate is frequently combined with other chemotherapy agents to improve response. This study may help increase the understanding of lenalidomide and nivolumab use in primary CNS lymphoma treatment. In addition, it may help researchers see whether the control of CNS lymphoma can be extended by using these study drugs as maintenance (prolonged therapy) after control is achieved with the initial chemotherapy regimen (induction).

Key Dates

First listed

Oct 30, 2020

Start date

May 24, 2021

Status verified

Sep 2026

Primary completion

Apr 1, 2027

Completion

Apr 1, 2027

Study Design

Enrollment

47 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (rituximab, methotrexate, lenalidomide, nivolumab)
  INDUCTION: Patients receive rituximab IV on day 1, methotrexate IV over 2 hours or PO on day 2, lenalidomide PO daily on days 5-9, and nivolumab IV over 30 minutes on day 14. (In dose level IV that includes nivolumab, the doses of rituximab for cycles 2-6 may be given on the same day as nivolumab for the previous cycle). Treatment repeats every 14 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response, partial response, or stable disease proceed to maintenance therapy. MAINTENANCE: Within 6 weeks after the last dose of lenalidomide in induction therapy, patients receive lenalidomide PO daily on days 1-21, and nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI, CT, PET/CT, lumbar puncture, bone marrow aspirate and biopsy, testicular ultrasound and ECHO. (See Detailed Description)

Primary Outcome Measure

Maximum tolerated dose [ Time Frame: During the first 14-day cycle of treatment ]

Locations (56)

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