Actively Recruiting
Glofitamab With Obinutuzumab Pre-treatment for the Treatment of Central Nervous System Lymphoma
Led by City of Hope Medical Center · Updated on 2025-11-10
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how safe and tolerable the drug glofitamab is when given after a pre-treatment with obinutuzumab in adults with primary or secondary central nervous system (CNS) lymphoma. This phase Ib trial aims to understand the side effects and how well the combination works to treat CNS lymphoma. The study also explores how glofitamab crosses the blood-brain barrier and evaluates treatments to manage related side effects like cytokine release syndrome and neurotoxicity. Participants receive obinutuzumab through an intravenous (IV) infusion on day 1 of cycle 1. Glofitamab is then given IV over 2 to 4 hours on days 8 and 15 of cycle 1, and on day 1 of each following 21-day cycle. Treatment can continue for up to 12 cycles unless the disease progresses or unacceptable side effects occur. During the study, patients undergo imaging scans like CT, PET/CT, and brain MRI, along with cerebrospinal fluid and blood sample collections. Those with certain disease involvement may also have lumbar punctures. Throughout the trial, patients are closely monitored with scans and laboratory tests to assess response and safety. After completing treatment, follow-up visits occur at 30 days and then every few months up to 24 months. The main outcomes measured include serious side effects during the first two cycles and overall treatment responses, including survival and disease progression over two years. The study helps researchers understand how this treatment combination affects CNS lymphoma and its side effects.
CONDITIONS
Brief Title
Glofitamab With Obinutuzumab Pre-treatment for the Treatment of Central Nervous System Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide documented informed consent and assent if appropriate
- Agree to allow use of archival tumor tissue or obtain approval if unavailable
- Be 18 years of age or older
- Have Karnofsky performance status of 30 or higher
- Have confirmed primary or secondary CNS lymphoma with CD20 positive tumor
- Not require urgent treatment due to critical brain conditions such as midline shift or brain herniation risk
- Have failed or be ineligible/refuse high-dose methotrexate treatment
- Have measurable CNS lymphoma by MRI or positive cerebrospinal fluid cytology
- Be recovered to grade 1 or better from prior acute cancer therapy toxic effects except hair loss
- Be alert and able to participate in neurological exams
- Meet blood count and platelet thresholds depending on bone marrow involvement
- Have hemoglobin of at least 8.0 g/dL
- Have liver and kidney function within specified limits
- Have appropriate coagulation test results
- Be seronegative or stable with controlled HIV, hepatitis B, or hepatitis C infections as specified
- Women of childbearing potential must have negative pregnancy test and agree to effective contraception
- Men must agree to effective contraception or abstinence during and after treatment as specified
- Agree to abstinence or contraception methods with specified failure rates
- Meet childbearing potential definitions as specified
You will not qualify if you...
- Allergy or severe reaction to glofitamab components or murine products
- Prior solid organ transplant
- Recent treatment with systemic immunotherapies including monoclonal antibodies within 2 weeks
- Prior treatment with glofitamab or similar bispecific antibodies
- Recent systemic chemotherapy within 2 weeks
- Recent intrathecal chemotherapy within 1 week
- Recent radiotherapy within 2 weeks unless specific lesion criteria are met
- Prior CAR-T therapy within 30 days
- Use of investigational cancer therapies within 21 days
- Use of corticosteroids except for lymphoma symptom control or specific allowed uses
- History of other malignancies affecting study compliance unless specific remission or low-risk criteria are met
- Unstable heart disease or recent major surgery
- History of CNS diseases other than lymphoma unless stable for 2 years
- Known or suspected hemophagocytic lymphohistiocytosis
- Abnormal ECG deemed clinically significant
- Active or recent serious infections
- Active autoimmune diseases requiring immunosuppressive therapy except specified stable conditions
- Clinically significant liver disease
- Recent live vaccine use or planned live vaccination during study
- Suspected or confirmed tuberculosis
- History of progressive multifocal leukoencephalopathy
- Pregnancy or breastfeeding or intent to become pregnant within specified periods
- Any condition judged by investigator to contraindicate participation
- Inability to comply with study procedures as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 cycles of 21 days each
Participants receive obinutuzumab intravenously on day 1 of cycle 1 and glofitamab intravenously on days 8 and 15 of cycle 1 and day 1 of subsequent 21-day cycles, for up to 12 cycles unless disease progresses or unacceptable toxicity occurs. Participants undergo CT or PET/CT at screening, cerebrospinal fluid and blood sample collection, brain MRI throughout treatment. Those with secondary CNS lymphoma also undergo CT or PET/CT throughout treatment. Additional lumbar punctures may occur for participants with baseline cerebrospinal fluid involvement.
Multiple visits every 7 to 21 days during treatment cycles
Duration - Up to 24 months
After completing treatment, participants are followed up to monitor health status and outcomes with visits at 30 days and 3, 6, 9, 12, 18, and 24 months.
7 visits over 2 years
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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