Primary Central Nervous System Lymphoma study: Cognitive Assessment vs Obinutuzumab
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?
An investigational IV monoclonal antibody being studied as maintenance therapy for primary central nervous system lymphoma. It is designed to bind the CD20 protein on B‑cells and help the immune system destroy those cells.
Also referred to as Anti‑CD20 Monoclonal Antibody R7159, GA‑101, GA101, Gazyva, huMAB (CD20), R7159, RO 5072759, RO‑5072759, RO5072759.
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
- The study aims to see how well obinutuzumab works to keep the cancer from coming back after patients have had a complete or partial response.
- Who it's for
- Adults with primary central nervous system lymphoma who have achieved a complete or partial response to prior therapy.
- What's involved
- Participants will receive regular infusions of obinutuzumab and will have scheduled clinic visits and tests to monitor their health.
- 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
- Must be within 75 days of completion of first-line treatment regimen at the time of randomization
- 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)
- 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
- 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
- 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)
- 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)
- 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 is enrolling
- New York, New York, 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, but 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?
This study is enrolling now at New York, New York, United States; Portland, Oregon, United States; Hershey, Pennsylvania, United States; Burlington, Vermont, United States; Charlottesville, Virginia, United States; Seattle, Washington, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.