Actively Recruiting
Maintenance Obinutuzumab for Primary Central Nervous System Lymphoma in Patients With Complete or Partial Response
Led by Providence Health & Services · Updated on 2025-06-05
28
Participants Needed
7
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating maintenance treatment with obinutuzumab in patients who have primary central nervous system lymphoma (PCNSL) and have responded to first-line high-dose methotrexate-based chemotherapy. This phase II trial focuses on patients with CD20+ B-cell PCNSL who have achieved either a complete or partial response to prior treatment. The study aims to determine how maintenance obinutuzumab affects the duration of this response and also examines overall survival, neurocognitive function, quality of life, and neurotoxicity indicators. Participants are randomly assigned to one of two groups. One group receives obinutuzumab intravenously on days 1 and 2 during the first cycle, then on day 1 in subsequent cycles, repeated every 60 days for two years unless the disease progresses or unacceptable side effects occur. The other group is observed for two years without maintenance treatment. Both groups undergo assessments to evaluate the study outcomes. During the study, participants will have brain magnetic resonance imaging (MRI) to confirm responses, neurocognitive testing using several validated tools, and quality of life questionnaires at the start and up to two years after entering the study. Researchers will monitor progression-free survival, overall survival, neurotoxicity, and treatment safety throughout. Participation involves regular clinic visits for infusions or observation and scheduled assessments over the two-year period.
CONDITIONS
Brief 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...
- Diagnosed with CD20 positive B-cell primary central nervous system lymphoma confirmed by pathology
- Completed first-line high-dose methotrexate-based chemotherapy regimen with or without brain radiotherapy
- Within 75 days of completing first-line treatment at the time of randomization
- Achieved partial or complete response to first-line treatment confirmed by brain MRI within 30 days before randomization
- If lymphoma was detected in cerebrospinal fluid or eye at diagnosis or during treatment, repeated tests must show complete response
- Karnofsky performance status 60 or higher, or ECOG score 0, 1, or 2
- Signed informed consent form
- Able and willing to follow study requirements
- Total bilirubin less than 3 times upper limit of normal within 7 days before randomization
- Creatinine clearance above 30 mL/min within 7 days before randomization
- AST or ALT less than or equal to 5 times upper limit of normal within 7 days before randomization
- Platelet count 75,000 cells/mm3 or higher within 7 days before randomization
- Hemoglobin greater than 9 g/dL within 7 days before randomization
- Absolute neutrophil count above 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 time after last dose (women: 18 months, men: 180 days)
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 study drugs
- History of other malignancies that could interfere with study compliance or results interpretation
- Active infections requiring recent intravenous antibiotics or hospitalization within 4 weeks prior to randomization
- Major surgery within 4 weeks prior to randomization
- HIV infection
- Positive hepatitis B or C serology unless confirmed negative for viral DNA/RNA and under monitoring
- Pregnant or breastfeeding women
- Vaccination with live vaccines within 4 weeks prior to randomization
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - Up to 75 days before randomization
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 2 years
Participants in the treatment arm receive obinutuzumab intravenously on days 1 and 2 of the first cycle and on day 1 of subsequent cycles every 60 days for up to 2 years, unless disease progresses or toxicity is unacceptable. Participants in the observation arm are monitored without active treatment for 2 years.
Infusions every 60 days for 2 years (treatment arm); periodic observation visits for 2 years (observation arm)
Duration - 2 years
Participants undergo neurocognitive and quality of life assessments at study entry and at 2 years to evaluate neurotoxicity and overall well-being.
2 visits (at study entry and at 2 years)
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
H
Holly Rittenberry
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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