RecruitingPrimary Central Nervous System Lymphoma
Maintenance Obinutuzumab in Treating Patients With Central Nervous System Lymphoma Who Have Achieved a Complete or Partial Response
Eligible age
18+ yrs
Accepts
All genders
Locations
7 states
Healthy volunteers
No
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About this study
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.
Sponsor: Providence Health & Services
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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)
Where it's recruiting
New York
New York
Ohio
Cleveland
Oregon
Portland
Pennsylvania
Hershey
Vermont
Burlington
Virginia
Charlottesville
Washington
Seattle
Source: ClinicalTrials.gov · NCT06175000 · last updated 2025-06-05