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NCT06175000 · Providence Health & Services

Maintenance Obinutuzumab in Treating Patients With Central Nervous System Lymphoma Who Have Achieved a Complete or Partial Response

What this study is about

This randomly assigned 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 (full disappearance of disease signs) or a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment (significant shrinkage of disease signs). Immunotherapy with obinutuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to gro

View original scientific description

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).

Interventions

PROCEDURE

Cognitive Assessment

Ancillary studies to evaluate neurocognitive function at study entry and at 2 years after study entry.

BIOLOGICAL

Obinutuzumab

Given IV

OTHER

Quality of Life Assessment

Ancillary studies to evaluate quality of life at study entry and at 2 years after study entry.

Primary outcome measures

Partial response (PR) or complete response (CR) duration

Time frame: From the date of brain magnetic resonance imaging (MRI) after completion of first-line treatment which confirms PR or CR, to disease progression or death, assessed up to 2 years

PR or CR duration will be assessed using Kaplan-Meier product limit estimates and compared between patients with maintenance versus without obinutuzumab maintenance using the log-rank test. In addition, the Cox proportional hazard model will be used to estimate hazard ratios.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion 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 report.
  • 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 for creatinine clearance \< 100 ml/min is permitted
  • 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 repeated and must have indicated CR; Note: CR requires complete disappearance of all enhancing abnormalities on gadolinium-enhanced MRI; if CSF was positive for lymphoma cells at diagnosis or during first-line treatment and/or slit lamp examination was positive at diagnosis or during first-line treatment, then the CSF and vitreal studies must have been repeated and must have indicated CR; for CRu, some patients will have a small but persistent enhancing abnormality on MRI related to biopsy or focal hemorrhage; it is often difficult to ascertain whether this represents a residual nidus of tumor or scar tissue; if the abnormality does not change or slowly involutes without therapy and corticosteroids, it is reasonable to categorize as a CRu; at the time CR/CRu is determined, the patient should not have used corticosteroids for at least two weeks
  • 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 jelly while receiving obinutuzumab and \>= 18 months after the last dose of obinutuzumab for women, and 180 days after the last dose of obinutuzumab for men

Exclusion criteria

  • 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 curative intent, will also be excluded, unless the malignancy has been in remission without treatment for \>= 2 years prior to randomization
  • 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 to the completion of the course of antibiotics) within 4 weeks prior to study randomization
  • 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 considered for inclusion in the study on a case-by-case basis if they are hepatitis B viral deoxyribonucleic acid (DNA) negative and are willing to undergo ongoing HBV DNA testing by real-time polymerase chain reaction (PCR); patients with positive serology may be referred to a hepatologist or gastroenterologist for appropriate monitoring and management
  • 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

Where

  • New York, New York
  • Cleveland, Ohio
  • Portland, Oregon
  • Hershey, Pennsylvania
  • Burlington, Vermont
  • Charlottesville, Virginia
  • Seattle, Washington

Related conditions & keywords

Primary Central Nervous System Lymphoma

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Sep 23, 2026 · Source of record for eligibility and locations

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1 of 28 participants interested
4% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

New York

New York

Location available
WITHDRAWN

Cleveland

Ohio

Location available
RECRUITING

Portland

Oregon

Location available
RECRUITING

Hershey

Pennsylvania

Location available
RECRUITING

Burlington

Vermont

Location available
RECRUITING

Charlottesville

Virginia

Location available
RECRUITING

Seattle

Washington

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

Find More Lymphoma Trials by City

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Looking for Central Nervous System Lymphoma Treatment in New York?

Join others in New York exploring innovative treatment options through clinical research

Central Nervous System Lymphoma Treatment Options in New York, New York

If you're searching for Central Nervous System Lymphoma treatment in New York, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in New York, Cleveland, Portland and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Central Nervous System Lymphoma. All study-related care is provided at no cost to participants.

Local Sites
3 locations in New York
Now Enrolling
Up to 28 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Central Nervous System Lymphoma?

Potential Benefits

  • ✓Access to new treatment approaches before public availability
  • ✓Close monitoring by experienced medical professionals
  • ✓Study-related care provided at no cost
  • ✓Contribute to medical research for Central Nervous System Lymphoma

What to Expect

  • →Initial screening to determine eligibility
  • →Regular check-ups and monitoring visits
  • →Possible compensation for time and travel
  • →You can withdraw at any time

Frequently Asked Questions About This Central Nervous System Lymphoma Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06175000. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.