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New cocktail of drugs aims to tackle rare brain cancer

NCT ID NCT07185373

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Aug 20, 2026 · Updated 3 times

Summary

This trial is testing whether adding a targeted drug called orelabrutinib to standard chemotherapy can improve outcomes for people newly diagnosed with primary central nervous system lymphoma, a rare type of brain cancer. About 215 participants will be randomly assigned to one of three treatment groups. The study is not yet recruiting and is in phase 2/3.

What this could mean

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

Active substance
Orelabrutinib, teniposide, rituximab, methotrexate, dexamethasone
What this could lead to
If successful, this could offer a more effective first-line treatment for primary CNS lymphoma, potentially improving remission rates and delaying progression.
What could go wrong
This is an early-to-mid-stage trial (phase 2/3) with a relatively small sample size. The drug combination may cause significant side effects, and it is not yet known if it will outperform existing therapies.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 215 people

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

Started

Oct 2025

Expected to finish

Jul 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 to 75 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: * No prior systemic treatment for primary central nervous system lymphoma * Pathologically confirmed as diffuse large B-cell lymphoma subtype; with sufficient residual surgical specimens remaining after meeting the needs for pathological diagnosis and preservation * Aged 18-75 years (inclusive) * ECOG performance status ≤3 * Expected survival time exceeding 3 months * Major organ functions meeting the following standards: 1. Blood routine parameters (without growth factor support or blood transfusion within the past 7 days; 14 days for pegylated myeloid growth factors): absolute neutrophil count (ANC) ≥1.0×10⁹/L, platelet count (PLT) ≥75×10⁹/L, hemoglobin (Hb) ≥80g/L; 2. Blood biochemistry: total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN) or ≤3×ULN (for confirmed Gilbert syndrome with direct bilirubin within normal range); aspartate transaminase (AST) or alanine transaminase (ALT) ≤2.5×ULN; serum creatinine within normal range; estimated glomerular filtration rate (eGFR) ≥70ml/min; 3. Coagulation function: international normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5×ULN; * Ability to tolerate lumbar puncture and/or having an indwelling Ommaya reservoir * Peripheral blood flow cytometry showed no clonal B cells and no other extramedullary lesions. * Voluntary signing of a written informed consent form by the participant or their legal representative prior to trial screening, indicating their understanding of the study purpose, necessary procedures, and willingness to comply with the protocol and attend follow-up visits Exclusion Criteria: * Lymphoma involving sites outside the central nervous system (CNS) * Patients with a previous history of tumors * Patients with intraocular lymphoma or suspected diagnosis of intraocular lymphoma invasion * Uncontrolled or significant cardiovascular diseases, including: 1. New York Heart Association (NYHA) class Ⅲ-Ⅳ congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first administration of study drugs; clinically significant or treatment-requiring arrhythmias at screening; left ventricular ejection fraction (LVEF) \<50%; or patients with controlled coronary heart disease who are either not using anticoagulants/antiplatelet drugs or taking 2 or more anticoagulants/antiplatelet drugs orally. 2. Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy). 3. A history of clinically significant QTc interval prolongation, or QTc interval (calculated via Bazett's formula using manually collected screening data) \>470ms in females or \>450ms in males. 4. Refractory hypertension (blood pressure not controlled despite ≥1 month of optimal, tolerable doses of 2 or more antihypertensive drugs \[including diuretics\] with lifestyle modifications; or blood pressure controlled only with 3 or more antihypertensive drugs). * Active bleeding within 2 months prior to screening; use of anticoagulants/antiplatelet drugs for \<6 months; or a definite bleeding tendency as judged by the investigator (e.g., bleeding-risk esophageal varices, active local ulcer lesions). * Diabetic patients whose blood sugar remains poorly controlled after insulin treatment * A history of stroke or intracranial hemorrhage within 6 months prior to screening, excluding postoperative sequelae-related intracranial hemorrhage * A history of organ transplantation or allogeneic bone marrow transplantation * Surgical procedures within 6 weeks prior to screening (diagnostic examinations are not considered surgical procedures; insertion of vascular access devices is exempt from this exclusion criterion). * Use of Chinese herbal medicines with anti-tumor effects (as specified in the package insert, e.g., Compound Cantharidin Capsules) within 4 weeks prior to screening * Active or uncontrolled hepatitis B virus (HBV) infection (HBsAg positive and/or HBcAb positive with positive HBV DNA titer); HCV Ab positive; HIV positive. The following patients can be provisioned for continuous observation pending enrollment when given prophylactic anti-HBV (such as entecavir or tenofovir), including : 1. HBsAg positive with negative HBV DNA titer. 2. HBsAg negative, HBsAb negative, HBcAb positive, and negative HBV DNA titer Patients with positive HBV-DNA can be considered for enrollment only when the HBV-DNA value is less than 500IU/mL after treatment * Uncontrolled active systemic fungal, bacterial, viral, or other infections (defined as persistent infection-related symptoms/signs that do not improve despite appropriate antibiotic or other treatments) or requiring intravenous antibiotics * Administration of live vaccines or immunological agents within 4 weeks prior to enrollment. * Need for concurrent and continuous use of drugs with moderate/strong inhibitory or inductive effects on cytochrome P450 CYP3A. * Patients with hypersensitivity to orelabrutinib or its excipients (e.g., immediate or accelerated allergic reactions). * Patients with hypersensitivity to teniposide or its excipients (e.g., immediate or accelerated allergic reactions) * Clinically significant gastrointestinal abnormalities that may affect drug intake, transit, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or participants with total gastrectomy. * Participants with a history or current presence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia with severely impaired lung function, etc * Participants with chronic liver damage, severe fatty liver, or alcoholic liver disease. * Pregnant or lactating women; women of childbearing age who are unwilling to use contraception from the time of enrollment until 180 days after the last dose of the study drug (serum pregnancy test results must be negative within 14 days before the start of study drug treatment for women of childbearing potential); men who are not surgically sterilized and unwilling to use contraception during the study and until 180 days after the last dose of the study drug. * Presence of life-threatening diseases or severe organ dysfunction, deemed unsuitable for participation in the trial by the investigator. * Any mental or cognitive impairment that may limit the understanding and execution of the informed consent form or adherence to the study * Previous receipt of whole-brain radiotherapy for primary central nervous system lymphoma.

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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.

  1. The places running it

    15 sites. 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

  • Changhai Hospital

    NOT_YET_RECRUITING

    Shanghai, China

  • Department of Hematology, Qilu Hospital of Shandong University

    RECRUITING

    Jinan, China

  • First Affiliated Hospital of Fujian Medical University

    NOT_YET_RECRUITING

    Fuzhou, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, China

  • Huashan Hospital

    RECRUITING

    Shanghai, China

  • Huaxi Hospital

    RECRUITING

    Chengdu, China

  • Peking University Third Hospital

    NOT_YET_RECRUITING

    Beijing, China

  • RenJi Hospital

    NOT_YET_RECRUITING

    Shanghai, China

  • Shanghai Tongji Hospital, Tongji University School of Medicine

    RECRUITING

    Shanghai, China

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    NOT_YET_RECRUITING

    Guangzhou, China

  • Tang-Du Hospital

    RECRUITING

    Xi'an, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, China

  • The Tumor Hospital of Jiangsu Province

    NOT_YET_RECRUITING

    Nanjing, China

  • WuhanUnionHospital

    RECRUITING

    Wuhan, China

  • Xuanwu Hospital

    RECRUITING

    Beijing, China

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