Is NCT06175000 recruiting in Charlottesville, VA?

Yes, NCT06175000 is currently recruiting participants at its Charlottesville, VA location. This central nervous system lymphoma clinical trial is actively enrolling qualified participants.

Is participation in this Charlottesville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Central Nervous System Lymphoma Clinical Trial in Charlottesville, VA

Q: How do I join the central nervous system lymphoma clinical trial in Charlottesville?

To join this clinical trial in Charlottesville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Central Nervous System Lymphoma Study in Charlottesville

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 gro

Sponsor: Providence Health & Services

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Charlottesville?

Yes, this clinical trial (NCT06175000) has an active research site in Charlottesville, VA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Central Nervous System Lymphoma Treatment Options in Charlottesville, VA

If you're searching for central nervous system lymphoma treatment options in Charlottesville, VA, this clinical trial (NCT06175000) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Charlottesville research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced central nervous system lymphoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all central nervous system lymphoma clinical trials near you to find additional studies recruiting in your area.

Central Nervous System Lymphoma Clinical Trial in Charlottesville, VA

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