Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Can a new drug combo reach lymphoma hiding in the brain?

NCT ID NCT07812493

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

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

14 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for CNS involvement of systemic lymphoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.