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Maintenance Obinutuzumab for Central Nervous System Lymphoma

This study is testing if obinutuzumab, an immunotherapy drug, can help people with central nervous system lymphoma (cancer that starts in the brain or spinal cord) stay in remission longer. You could be eligible if you have CD20+ B-cell primary central nervous system lymphoma, are 18 or older, and have already had initial treatment with high-dose methotrexate-based chemotherapy, achieving either a complete response (all signs of cancer gone) or a partial response (cancer has shrunk). Researchers want to see if obinutuzumab can extend the time before the cancer grows or returns. They will also look at your quality of life and brain function. The study is currently unclear on its recruitment status and plans to enroll 28 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a randomized study, so you would be assigned by chance to either receive obinutuzumab or be observed.
What's involved
If you are in the treatment group, you would receive obinutuzumab intravenously every 60 days for up to two years. All participants will have cognitive and quality of life assessments at the start and after two years.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be assessed for up to two years from the date of your brain MRI after first-line treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06175000

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Providence Health & Services
~28 participants
Updated 2025-06-05 on ClinicalTrials.gov
What's tested:Cognitive AssessmentObinutuzumabQuality of Life Assessment

At a glance

Recruiting sites
5 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Partial response (PR) or complete response (CR) duration
Measured over From the date of brain magnetic resonance imaging (MRI) after completion of first-line treatment which confirms PR or CR, to disease progression or death, assessed up to 2 years

Conditions

Primary Central Nervous System Lymphoma

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Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cleveland Clinic

    Cleveland, Ohiostudy coordinator listed

    Not yet recruiting

  • Ivy Center for Advanced Brain Tumor Treatment; Swedish Neuroscience Institute

    Seattle, Washingtonstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New Yorkstudy coordinator listed

    Not yet recruiting

  • Pennsylvania State University

    Hershey, Pennsylvaniastudy coordinator listed

    Recruiting

  • Providence Health & Services; Providence Neurological Specialties

    Portland, Oregonstudy coordinator listed

    Recruiting

  • University of Vermont

    Burlington, Vermontstudy coordinator listed

    Recruiting

  • University of Virginia

    Charlottesville, Virginiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Prakash Ambady, MD · PRINCIPAL_INVESTIGATOR · Providence Health & Services

Who to contact

Tiffany Gervasi-Follmar
[email protected]
503-216-1023
Email the study team

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Eligibility criteria

Inclusion

CD20+ B-cell primary central nervous system lymphoma (PCNSL) confirmed at the time of diagnosis by histology, cytology, or immunocytochemistry from cerebrospinal fluid (CSF); diagnosis must be documented by pathology report.
Must have undergone first-line treatment with a high-dose methotrexate-based chemotherapy regimen with or without brain radiotherapy; high-dose methotrexate is defined as \>= 3 grams/m\^2; methotrexate dose reduction for creatinine clearance \< 100 ml/min is permitted
Must be within 75 days of completion of first-line treatment regimen at the time of randomization; must have achieved objective response (PR or CR/unconfirmed complete response \[CRu\]) to first-line treatment
Brain magnetic resonance imaging (MRI) documenting objective response must be obtained within 30 days before randomization
If CSF was positive for lymphoma cells at diagnosis or during first-line treatment and/or a slit lamp examination was positive at diagnosis or during first-line treatment, then the CSF and vitreal studies must have been repeated and must have indicated CR; Note: CR requires complete disappearance of all enhancing abnormalities on gadolinium-enhanced MRI; if CSF was positive for lymphoma cells at diagnosis or during first-line treatment and/or slit lamp examination was positive at diagnosis or during first-line treatment, then the CSF and vitreal studies must have been repeated and must have indicated CR; for CRu, some patients will have a small but persistent enhancing abnormality on MRI related to biopsy or focal hemorrhage; it is often difficult to ascertain whether this represents a residual nidus of tumor or scar tissue; if the abnormality does not change or slowly involutes without therapy and corticosteroids, it is reasonable to categorize as a CRu; at the time CR/CRu is determined, the patient should not have used corticosteroids for at least two weeks
Karnofsky performance status (KPS) \>= 60; Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2
Signed informed consent form (ICF)
Ability and willingness to comply with the requirements of the study protocol
Total bilirubin \< 3 x the upper limit of normal (ULN), ≤ 7 days before date of randomization
Creatinine clearance \> 30 mL/min (calculated according to institutional standards or using Cockcroft-Gault formula), ≤ 7 days before date of randomization
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 5 x ULN, ≤7 days before date of randomization
Platelet ≤ 75,000 cells/mm\^3, ≤ 7 days before date of randomization
Hemoglobin \> 9 g/dL, ≤ 7 days before date of randomization
Absolute neutrophil count \> 1.5 x 10\^3 cells/mm\^3, ≤ 7 days before date of randomization
Surgically sterile or agree to use effective contraception using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly while receiving obinutuzumab and \>= 18 months after the last dose of obinutuzumab for women, and 180 days after the last dose of obinutuzumab for men

Exclusion

History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
Clinical evidence of extra-central nervous system (CNS) (systemic) non-Hodgkin lymphoma
Known hypersensitivity to any of the study drugs
History of other malignancy that could affect compliance with the protocol or interpretation of results
Patients with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are generally eligible; patients with a malignancy that has been treated, but not with curative intent, will also be excluded, unless the malignancy has been in remission without treatment for \>= 2 years prior to randomization
Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (related to the completion of the course of antibiotics) within 4 weeks prior to study randomization
Major surgery within 4 weeks prior to study randomization
Known infection with human immunodeficiency virus (HIV)
Positive hepatitis serologies:
Hepatitis B (HBV): patients with positive serology for hepatitis B defined as positivity for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (anti-HBc); patients who are positive for anti-HBc may be considered for inclusion in the study on a case-by-case basis if they are hepatitis B viral deoxyribonucleic acid (DNA) negative and are willing to undergo ongoing HBV DNA testing by real-time polymerase chain reaction (PCR); patients with positive serology may be referred to a hepatologist or gastroenterologist for appropriate monitoring and management
Hepatitis C (HCV): patients with positive hepatitis C serology unless HCV ribonucleic acid (RNA) is confirmed negative and may be considered for inclusion in the study on a case-by-case basis
Women who are pregnant or lactating
Vaccination with a live vaccine a minimum of 4 weeks prior to study randomization

What this trial measures

  • Partial response (PR) or complete response (CR) durationFrom the date of brain magnetic resonance imaging (MRI) after completion of first-line treatment which confirms PR or CR, to disease progression or death, assessed up to 2 years

    PR or CR duration will be assessed using Kaplan-Meier product limit estimates and compared between patients with maintenance versus without obinutuzumab maintenance using the log-rank test. In addition, the Cox proportional hazard model will be used to estimate hazard ratios.