New hope for brain cancer: targeted drug combo shows promise
NCT ID NCT07405255
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests a combination of zanubrutinib (a targeted drug) plus chemotherapy for people newly diagnosed with central nervous system lymphoma. Nineteen participants will receive the treatment, with an extra drug for those with a specific gene mutation. The goal is to see if the combo can achieve complete remission and keep the disease under control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- zanubrutinib, rituximab, methotrexate, and possibly selinexor
- What this could lead to
- If successful, this could offer a new treatment option for central nervous system lymphoma, potentially improving remission rates and long-term control.
- What could go wrong
- This is a small, early-phase trial with only 19 participants, so results may not apply broadly. The combination therapy may cause significant side effects, and the disease is aggressive.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 19 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Have a full understanding of this study and voluntarily sign the informed consent form. * Untreated patients with primary central nervous system lymphoma (PCNSL) confirmed by pathology (immunotyping) according to the 2016 WHO classification of lymphoid neoplasms. * Diffuse large B-cell lymphoma (DLBCL) originating from the central nervous system (CNS) without involvement of other organs, confirmed by PET-CT or contrast-enhanced CT. * Expected survival greater than 3 months. * Laboratory test results meeting all of the following: * Creatinine clearance rate ≥ 50 mL/min (calculated by the Cockcroft-Gault formula). * International normalized ratio (INR) ≤ 1.5 × ULN or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. Patients on warfarin may have INR 2-3. * Left ventricular ejection fraction (LVEF) ≥ 50%. * Glomerular filtration rate (GFR) ≥ 60 mL/min. * Male or female patients of childbearing potential must agree to use effective contraception (e.g., double-barrier methods, condoms, oral or injectable contraceptives, intrauterine device) during the study and for 30 days after the last dose. * Postmenopausal women (\> 45 years old and amenorrheic \> 1 year) or surgically sterilized women are exempt from this requirement. Exclusion Criteria: * Contraindication to any drug included in the treatment regimen. * History of clinically significant liver disease, including viral or other hepatitis or cirrhosis. * Hepatitis B: Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with HBV-DNA above ULN. * Active hepatitis C: Positive HCV antibody with detectable HCV-RNA. * Human Immunodeficiency Virus (HIV) infection. * Congestive heart failure (New York Heart Association Class \> II) or history within 6 months of acute myocardial infarction, unstable angina, stroke, or transient ischemic attack. * Hereditary long QT syndrome or QTc \> 480 ms (QTc calculated using Fridericia's formula, QTcF = QT / RR\^0.33). * Other malignancies within 5 years, except: completely cured cervical carcinoma in situ, basal cell carcinoma of the skin, breast carcinoma in situ, or another primary cancer that has been cured and not recurred within 5 years. * Pregnant or lactating women, or women planning pregnancy during the study period. * History of significant neurological or psychiatric disorders, including substance or psychotropic-drug abuse. * Clinically significant active infection. * Inability to take or swallow oral medication, or conditions affecting drug absorption (e.g., chronic diarrhea, intestinal obstruction).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ruijin Hospital
Shanghai, Shanghai Municipality, 200025, China
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