Actively Recruiting
Maintenance Obinutuzumab in Treating Patients With Central Nervous System Lymphoma Who Have Achieved a Complete or Partial Response
Led by Providence Health & Services · Updated on 2025-06-05
28
Participants Needed
7
Research Sites
287 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Maintenance Obinutuzumab in Treating Patients With Central Nervous System Lymphoma Who Have Achieved a Complete or Partial Response
Who Can Participate
Eligibility Criteria
You may qualify if you...
- CD20+ B-cell primary central nervous system lymphoma confirmed by pathology at diagnosis
- Completed first-line high-dose methotrexate-based chemotherapy with or without brain radiotherapy
- Within 75 days after finishing first-line treatment at randomization
- Achieved partial response (PR), complete response (CR), or unconfirmed complete response (CRu) to first-line treatment
- Brain MRI showing objective response within 30 days before randomization
- If cerebrospinal fluid (CSF) or slit lamp tests were positive at diagnosis or during treatment, repeat tests must show complete response
- Karnofsky performance status of 60 or higher or ECOG status 0, 1, or 2
- Signed informed consent and willingness to comply with study requirements
- Total bilirubin less than 3 times the upper limit of normal within 7 days before randomization
- Creatinine clearance greater than 30 mL/min within 7 days before randomization
- AST or ALT less than or equal to 5 times the upper limit of normal within 7 days before randomization
- Platelet count greater than or equal to 75,000 cells/mm3 within 7 days before randomization
- Hemoglobin greater than 9 g/dL within 7 days before randomization
- Absolute neutrophil count greater than 1.5 x 10^3 cells/mm3 within 7 days before randomization
- Surgically sterile or agree to use effective contraception during treatment and for specified times after
You will not qualify if you...
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
- Evidence of systemic non-Hodgkin lymphoma outside the central nervous system
- Known hypersensitivity to any study drugs
- History of other malignancies that affect compliance or results interpretation
- Active bacterial, viral, fungal, mycobacterial, or other infections requiring recent IV antibiotics or hospitalization
- Major surgery within 4 weeks prior to randomization
- Known HIV infection
- Positive hepatitis B surface antigen or core antibody without proper viral DNA monitoring
- Positive hepatitis C serology unless RNA negative
- Women who are pregnant or breastfeeding
- Vaccination with live vaccine within 4 weeks prior to randomization
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Not Yet Recruiting
2
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
3
Providence Health & Services; Providence Neurological Specialties
Portland, Oregon, United States, 97225
Actively Recruiting
4
Pennsylvania State University
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
5
University of Vermont
Burlington, Vermont, United States, 05405
Actively Recruiting
6
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
7
Ivy Center for Advanced Brain Tumor Treatment; Swedish Neuroscience Institute
Seattle, Washington, United States, 98122
Actively Recruiting
Research Team
T
Tiffany Gervasi-Follmar
CONTACT
H
Holly Rittenberry
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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