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New treatment option for Primary Central Nervous System Lymphoma
Official title Maintenance Obinutuzumab in Treating Patients With Central Nervous System Lymphoma Who Have Achieved a Complete or Partial Response
ClinicalTrials.gov ID: NCT06175000
What this study is testing
What is Obinutuzumab?
Obinutuzumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for primary central nervous system lymphoma.
Also referred to as Anti-CD20 Monoclonal Antibody R7159, GA-101.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- CD20+ B-cell primary central nervous system lymphoma (PCNSL) confirmed at the time of diagnosis by histology, cytology, or immunocytochemistry from...
- Must have undergone first-line treatment with a high-dose methotrexate-based chemotherapy regimen with or without brain radiotherapy; high-dose...
- Must be within 75 days of completion of first-line treatment regimen at the time of randomization; must have achieved objective response (PR or...
- 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...
You likely can't join 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...
- Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Hershey, Pennsylvania, United States
- Burlington, Vermont, United States
- Charlottesville, Virginia, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States; Cleveland, Ohio, United States; Portland, Oregon, United States; Hershey, Pennsylvania, United States; Burlington, Vermont, United States; Charlottesville, Virginia, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.