RecruitingPhase 2NCT06175000

Maintenance Obinutuzumab in Treating Patients With Central Nervous System Lymphoma Who Have Achieved a Complete or Partial Response

Maintenance Obinutuzumab for Primary Central Nervous System Lymphoma Complete or Partial Responders


Sponsor

Providence Health & Services

Enrollment

28 participants

Start Date

Mar 13, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This randomized phase II trial studies how well obinutuzumab works as maintenance treatment in patients with central nervous system lymphoma who have achieved the disappearance of all signs of cancer in response to treatment (complete response) or a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment (partial response). Immunotherapy with obinutuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether using a drug called obinutuzumab as maintenance therapy — given regularly after completing first-line treatment — can prevent the return of primary central nervous system lymphoma (PCNSL), a rare blood cancer that occurs inside the brain or spinal cord. **You may be eligible if...** - You have been diagnosed with CD20-positive B-cell primary CNS lymphoma (a type of lymphoma in the brain/spinal cord) - You have completed first-line chemotherapy (high-dose methotrexate-based) and achieved a partial or complete response - You are within 75 days of finishing your first-line treatment - You have had a brain MRI confirming your response to treatment **You may NOT be eligible if...** - You did not respond to first-line treatment (your lymphoma didn't shrink) - You have significant organ dysfunction affecting your heart, kidneys, or lungs - You are pregnant or breastfeeding - You have active, uncontrolled infections 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

PROCEDURECognitive Assessment

Ancillary studies to evaluate neurocognitive function at study entry and at 2 years after study entry.

BIOLOGICALObinutuzumab

Given IV

OTHERQuality of Life Assessment

Ancillary studies to evaluate quality of life at study entry and at 2 years after study entry.


Locations(7)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Providence Health & Services; Providence Neurological Specialties

Portland, Oregon, United States

Pennsylvania State University

Hershey, Pennsylvania, United States

University of Vermont

Burlington, Vermont, United States

University of Virginia

Charlottesville, Virginia, United States

Ivy Center for Advanced Brain Tumor Treatment; Swedish Neuroscience Institute

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06175000


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