Study on Maintenance Obinutuzumab for Patients with Central Nervous System Lymphoma Who Have Responded to Treatment

Sponsor: Providence Health & Services

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06175000

Provider View

This clinical trial is exploring how well the drug obinutuzumab works as a maintenance treatment for patients with central nervous system lymphoma who have shown a positive response to initial treatment. The study aims to see if obinutuzumab can help keep the cancer from growing or spreading.

Patient Parameters

Program Overview

The purpose of this study is to find out if the drug obinutuzumab can help maintain the positive effects of initial treatment in patients with central nervous system lymphoma. This type of immunotherapy may help the body's immune system fight cancer cells and prevent them from growing or spreading. The study involves two groups: one group will receive obinutuzumab regularly, while the other group will be monitored without additional treatment.

Description

The main goal of this study is to see if obinutuzumab can help maintain the positive effects of initial treatment in patients with central nervous system lymphoma who have responded well to their first round of chemotherapy. Researchers will look at how long patients stay in remission, meaning their cancer does not get worse.

Secondary goals include evaluating overall survival rates, assessing patients' cognitive function and quality of life, and examining brain scans for signs of neurotoxicity.

Participants will be randomly assigned to one of two groups:

  • Group 1 (Maintenance Therapy): Patients will receive obinutuzumab through an IV on the first two days of the first cycle, and then on the first day of each following cycle. These cycles will repeat every 60 days for up to two years, as long as the cancer does not progress and side effects are manageable.

  • Group 2 (Observation): Patients will be closely monitored for two years without additional treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with CD20+ B-cell primary central nervous system lymphoma confirmed by lab tests.
  • Completed first-line treatment with high-dose methotrexate-based chemotherapy, possibly with brain radiotherapy.
  • Achieved a partial or complete response to initial treatment within 75 days of finishing it.
  • Recent brain MRI showing response to treatment.
  • If cancer was found in spinal fluid or eyes during initial treatment, follow-up tests must show complete response.
  • Good overall health with a performance status score of 60 or higher.
  • Signed informed consent and willingness to follow study requirements.
  • Meet specific blood test criteria for liver and kidney function, blood cell counts, and more.
  • Agree to use effective contraception during and after treatment.

Exclusion Criteria

  • Severe allergic reactions to similar treatments.
  • Evidence of lymphoma outside the central nervous system.
  • Allergies to study drugs.
  • Other cancers that could interfere with the study.
  • Active infections or recent major surgery.
  • Known HIV or hepatitis infections.
  • Pregnant or breastfeeding women.
  • Recent vaccination with a live vaccine.

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