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

Gå till den engelska sidan

Can a Four-Pronged attack beat brain lymphoma?

NCT ID NCT07749365

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This trial is testing whether combining a short course of focused radiation with three drugs—GM-CSF, pomalidomide, and glofitamab—can effectively treat newly diagnosed primary central nervous system diffuse large B-cell lymphoma (PCNSL), a rare and aggressive cancer of the brain or spinal cord. The study will enroll about 53 adults with this condition to see how many achieve a complete response, meaning no detectable cancer remains. The goal is to find a more powerful first-line treatment that could improve outcomes for patients with this challenging disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A combination of hypofractionated radiotherapy, GM-CSF, pomalidomide, and glofitamab
What this could lead to
If successful, this combination could offer a more effective first-line treatment for primary central nervous system lymphoma, potentially improving complete response rates and long-term outcomes.
What could go wrong
This is a phase II trial with a relatively small number of participants, so results may not be definitive. The combination may cause significant side effects, and the added benefit over standard therapy is not yet proven.

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 53 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

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

18 years and older

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: 1. Written informed consent must be obtained before any study-related procedures. 2. Age ≥18 years, regardless of sex, with an expected survival time \>3 months. 3. Histologically confirmed diffuse large B-cell lymphoma (DLBCL). 4. Newly diagnosed patients with primary central nervous system diffuse large B-cell lymphoma (PCNSL). 5. No previous treatment with bispecific antibodies. 6. B-cell non-Hodgkin lymphoma with at least one measurable lesion according to RECIST 1.1 criteria, or detectable abnormal monoclonal B cells by cerebrospinal fluid (CSF) flow cytometry. 7. Adequate organ function meeting the following laboratory criteria: * Total bilirubin ≤1.5 × upper limit of normal (ULN); * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN; * Serum creatinine ≤1.5 × ULN and creatinine clearance ≥60 mL/min (calculated using the Cockcroft-Gault formula); * Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN. 8. Women of childbearing potential must have a negative urine or serum pregnancy test within 3 days before the first dose of study treatment (Cycle 1 Day 1). If urine pregnancy testing cannot confirm a negative result, a serum pregnancy test is required. Women of non-childbearing potential are defined as those who are postmenopausal for ≥1 year or have undergone surgical sterilization or hysterectomy. 9. All participants with reproductive potential (male or female) must use highly effective contraception with a failure rate \<1% per year during treatment and for 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy). Exclusion Criteria: 1. Loss of CD20 expression in B-cell non-Hodgkin lymphoma. 2. Active acute or chronic hepatitis B or hepatitis C infection, including: * HBV DNA \>2,000 IU/mL or \>10⁴ copies/mL without willingness to receive regular antiviral therapy; * HCV RNA \>10³ copies/mL; * Concurrent positivity for HBsAg and anti-HCV antibody. 3. Receipt of anti-hematologic malignancy therapy within 2 weeks or within 5 pharmacokinetic half-lives before treatment initiation, whichever is longer. 4. Inadequate bone marrow reserve, defined as platelet count \<30 ×10⁹/L or absolute neutrophil count \<1.0 ×10⁹/L. 5. Clinically significant pulmonary diseases, including: * Chronic obstructive pulmonary disease (COPD) with FEV1 \<50% of predicted value; * Moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any severity. 6. Uncontrolled hypertension despite optimal medical management (systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg), history of hypertensive crisis, or hypertensive encephalopathy. 7. Symptomatic congestive heart failure (NYHA class II-IV), symptomatic or poorly controlled arrhythmias, congenital long QT syndrome, or corrected QT interval (QTc) \>500 ms (Fridericia correction). 8. Receipt of hypofractionated radiotherapy within 4 weeks before the first treatment. Patients receiving radiotherapy \>4 weeks before enrollment must have no ongoing radiation-related toxicities, no requirement for corticosteroids, and no evidence of radiation pneumonitis, hepatitis, enteritis, or other radiation-related complications. 9. Difficulty swallowing oral medications. 10. History or presence of pulmonary fibrosis, interstitial lung disease, pneumoconiosis, drug-induced pneumonitis, or severe pulmonary dysfunction. 11. HIV infection (positive HIV-1/2 antibody) or known syphilis infection. 12. Presence of unhealed wounds, fractures, gastric or duodenal ulcers, persistent positive fecal occult blood test, ulcerative colitis, or other conditions associated with risk of gastrointestinal bleeding or perforation as determined by the investigator. 13. Active or uncontrolled severe infection, including severe infection requiring hospitalization due to infection, bacteremia, or severe pneumonia within 4 weeks before the first dose. 14. Major surgery or significant traumatic injury within 4 weeks before the first dose. 15. Use of traditional Chinese medicine with antitumor indications within 2 weeks before the first dose. 16. Known hypersensitivity to any component of bispecific antibodies or GM-CSF preparations. 17. Receipt of treatment in another clinical trial within 4 weeks before the first dose. 18. Pregnant or breastfeeding women. 19. Active autoimmune disease or history of autoimmune disease, including but not limited to autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, and nephritis. Patients requiring medical intervention with bronchodilators for asthma are excluded. The following conditions are permitted: vitiligo, psoriasis, alopecia, or controlled type I diabetes not requiring systemic treatment, and hypothyroidism controlled with hormone replacement therapy. 20. Any other acute or chronic disease, psychiatric condition, or abnormal laboratory finding that may: * Increase the risk associated with study participation or administration of study treatment; * Interfere with interpretation of study results; * Render the patient unsuitable for participation according to the investigator's judgment.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for DLBCL - diffuse large B cell 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

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, Fujian, 361003, China

More trials for these conditions

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