Can a new drug combo reach lymphoma hiding in the brain?
NCT ID NCT07812493
First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
Researchers are testing whether adding pirtobrutinib to methotrexate and standard chemoimmunotherapy can help people with diffuse large B-cell lymphoma that has spread to the central nervous system. The trial enrolls about 24 people aged 14 to 80 whose lymphoma involves the brain or spinal fluid. Everyone receives the same open-label combination, and the main goal is to see how many reach complete remission after six cycles of induction therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pirtobrutinib combined with methotrexate and standard chemoimmunotherapy
- What this could lead to
- If it works, this combination could offer a way to treat lymphoma that has spread to the brain and spinal fluid, a setting where standard chemotherapy often struggles to reach.
- What could go wrong
- This is a small phase 2 trial with 24 participants and no comparison group, so any benefit seen may not hold up in larger studies. Adding pirtobrutinib and high-dose methotrexate to chemoimmunotherapy may also increase side effects.
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 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2030
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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14 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: Patients must satisfy all of the following conditions to be enrolled in this study: 1.Fully understand the study and voluntarily provide written informed consent. 2.Age: 14-80 years old. 3.Estimated survival of more than 3 months as judged by the investigator. 4.Histologically or cytologically / flow-cytometry confirmed B-cell-derived diffuse large B-cell lymphoma (DLBCL). 5.Central nervous system (CNS) involvement: diagnosis is established if any one of the following is present: symptoms related to CNS involvement, abnormal imaging findings, or pathological evidence (positive cerebrospinal fluid (CSF) cytology, positive biopsy of brain parenchymal lesions, or positive CSF-ctDNA). 6.Non-hematologic toxicities related to prior therapy shall have recovered to Grade 1 or baseline (per NCI-CTCAE Version 5.0), alopecia excluded. 7.Bone marrow and organ function meet the following criteria (no blood transfusion, G-CSF administration, or pharmacologic correction within 14 days prior to screening): 1. Bone marrow function: absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L; platelet count ≥ 50 × 10⁹/L; hemoglobin ≥ 60 g/L. 2. Liver function: serum total bilirubin ≤ 1.5 × ULN (≤ 3.0 × ULN in the presence of liver involvement); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5.0 × ULN in the presence of liver involvement). 3. Coagulation function: international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. 4. Renal function: serum creatinine ≤ 1.5 × ULN or estimated creatinine clearance ≥ 30 mL/min. 5. Calculationformula(Cockcroft-Gault):Male:Cr(mL/min) = (140 - age) × bodyweight (kg) / (72 × serum creatinine(mg/dL))Female:Cr(mL/min) = (140 - age) × body weight (kg) × 0.85 / (72 × serum creatinine (mg/dL)) 8.Women of child-bearing potential and men with reproductive potential have no plan for conception with their partners during the study and for 3 months after treatment discontinuation. They must adopt one of the following effective contraceptive measures throughout the study period and for 3 months after treatment discontinuation: abstinence, physical contraception (e.g., sterilization, condoms), or hormonal contraceptives initiated at least 3 months prior to the first study drug administration. Male subjects shall refrain from sperm donation from treatment initiation through 3 months after treatment discontinuation. The patient or legal guardian voluntarily signs the informed consent form. 9.Good compliance and willingness to adhere to visit schedules, drug administration plans, laboratory tests, and other study procedures. exclusion Criteria: Patients meeting any one of the following criteria will be excluded from this study: 1. Contraindication to any drug in the treatment regimen. 2. History of active liver disease, including viral or other hepatitis, or liver cirrhosis. (Active hepatitis B is defined as HBV-DNA above the upper limit of normal; active hepatitis C is defined as positive HCV antibody. Subjects with positive HCV antibody but negative HCV-RNA are eligible for enrollment.) 3. Human immunodeficiency virus (HIV) infection. 4. Congestive heart failure (New York Heart Association \[NYHA\] functional class \> 2); medical history of acute myocardial infarction, unstable angina pectoris, stroke, or transient ischemic attack within the preceding six months. 5. Congenital long-QT syndrome, or QTc \> 480 ms. (Note: QTc interval shall be calculated by the Fridericia's formula: QTcF = QT/(RR)\^0.33.) 6. Pregnant or breastfeeding women, or subjects planning to become pregnant during the study period. 7. Documented prior history of neurological or psychiatric disorders; or history of psychotropic substance abuse or illicit drug use.
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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 Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
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Other studies related to the condition(s) this trial covers.
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- Can a targeted drug boost standard chemo for aggressive lymphoma?
- Can a targeted drug combo outsmart an aggressive lymphoma?
- Can a reshaped chemo combo tame lymphoma with fewer side effects?