Recruiting
Phase 2

Obinutuzumab

Sponsor:

Providence Health & Services

Code:

NCT06175000

Conditions

Primary Central Nervous System Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive Assessment

Obinutuzumab

Quality of Life Assessment

Study Details

Brief summary:

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.

Conditions

Primary Central Nervous System Lymphoma

Study ID

NCT06175000

Start date

Mar 13, 2024

Status verified date

Jun, 2025

Completion date

Sep 15, 2029

Anticipated

Primary completion date

Sep 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

28 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm I (obinutuzumab

Patients receive obinutuzumab IV on days 1 and 2 for the first cycle, and on day 1 for the subsequent cycles, and on day 1 for the subsequent cycles. Cycles repeat every 60 days for 2 years in the absence of disease progression or unacceptable toxicity.

active comparator: Arm II (observation)

Patients undergo observation for a total of 2 years.

Interventions

Cognitive Assessment

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

Obinutuzumab

Given IV

Quality of Life Assessment

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Tiffany Gervasi-Follmar

503-216-1023tiffany.gervasi-follmar@providence.org

Holly Rittenberry

503-216-1034Holly.Rittenberry@providence.org

Locations

Providence Health & Services; Providence Neurological Specialties

Recruiting

Portland, Oregon, United States, 97225

Contacts

Kai Darke

503-216-0627kai.darke@providence.org

Tigest Mequanint

503-216-0875tigest.mequanint@providence.org

Principal Investigator:

Prakash Ambady, MD

Pennsylvania State University

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Micaiah Grien

717-531-0003mgrien@pennstatehealth.psu.edu

Sara Craig

717-531-0003scraig2@pennstatehealth.psu.edu

Principal Investigator:

Dawit Aregawi, MD

University of Vermont

Recruiting

Burlington, Vermont, United States, 05405

Contacts

Isza Parchini

802-656-9447isza.parchini@uvahealth.org

George Davis

george.davis@uvmhealth.org

Principal Investigator:

Alissa Thomas, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Nija Desai

434-982-6455NND2A@uvahealth.org

Patrick Heffernan

434-243-9508YWW2NJ@uvahealth.org

Principal Investigator:

David Schiff, MD

Ivy Center for Advanced Brain Tumor Treatment; Swedish Neuroscience Institute

Recruiting

Seattle, Washington, United States, 98122

Contacts

Gary Brown

206-320-2608gary.brown@swedish.org

Nathan Hansen

206-320-3542nathan.hansen@swedish.org

Principal Investigator:

Alipi Bomn, MD

More Information

Sponsor

Providence Health & Services

Last update posted

Jun 5, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-16. This information was provided to ClinicalTrials.gov by Providence Health & Services on 2025-06-05.