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

This phase I trial is to find out the best dose, possible benefits and/or side effects of lenalidomide when added to nivolumab and the usual drugs (rituximab and methotrexate) in patients with primary central nervous system (CNS) lymphoma.

Age & Gender

  • 18 years ~ 99 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

You will be given intravenous induction chemotherapy every 2 weeks for twelve weeks overall. Each chemotherapy treatment during this induction period includes an overnight hospital stay. During the maintenance period treatment, you will take the study drug lenalidomide, and track your usage in a drug diary, and perhaps an infusion of the study drug nivoumab every 4 weeks for up to twelve times. Study procedures include regular bloods draws, and three lumbar punctures before and during treatment, to to better understand how the new agents - nivolumab and lenalidomide - affect the central nervous system.

Incentives

You or your insurance provider will not have to pay for the study drugs lenalidomide and/or nivolumab while you take part in this study

In-person visits:
6-24
Total length of participation:
Treatment is 12 - 48 weeks long, with 2 years of follow-up visits every 3 months

Looking for Specific Volunteers

Able to participate:

  • You have been diagnosed with primary CNS (central nervous system) diffuse large B-cell lymphoma
  • You have at least one lesion in the brain greater than or equal to 1cm in length
  • You are 18 years or older

Not eligible if:

  • You have had any type of organ transplantation or stem cell transplant
  • You have had any prior chemotherapy or radiation therapy for lymphoma
  • You are being treated with corticosteroids on an ongoing basis
  • You have an auto-immune disorder

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Christopher Dittus
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Lymphoma)

IRB Number

22-3183

ClinicalTrials.gov

NCT04609046

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