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Can a targeted drug combo outsmart brain lymphoma?

NCT ID NCT05036577

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This early-stage trial is testing whether adding the targeted drug orelabrutinib to a standard chemotherapy regimen can safely treat newly diagnosed primary central nervous system lymphoma (PCNSL), a rare type of lymphoma that starts in the brain or spinal cord. The study will enroll about 13 people with this condition who have not yet received treatment. The main goals are to find the safest dose of orelabrutinib when combined with the other drugs and to see how well the combination works at shrinking tumors.

What this could mean

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

Active substance
Orelabrutinib combined with rituximab, methotrexate, and dexamethasone
What this could lead to
If successful, this combination could offer a new, more effective treatment option for primary central nervous system lymphoma, potentially improving outcomes without the need for whole-brain radiation.
What could go wrong
This is a small, early-phase dose-finding study, so safety and the best dose are still being determined. The combination may cause significant side effects, and it is too soon to know if it will be more effective than current standard treatments.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

13 people

The number who actually took part.

Started

Oct 2021

Finished

Mar 2025

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: * anti-neoplasm systemic treatement naive primary central nervous system lymphoma * Pathological type is diffuse large B cell lymphoma * Enough residual sample of tumor after pathological diagnosis * ECOG =\<3 * Life expectancy \>3 months * Adequate organ function and adequate bone marrow reserve * Must be able to tolerate lumbar puncture and/or have Omaya tube * Participant or his/her legal agent must be willing to sign a written informed consent document. Exclusion Criteria: * Lymphoma invading outside CNS * Lymphoma only existed in vitreo-retina * Severe or uncontrolled cardiovascular disease * Active hemorrhage within 2 months prior screening * Cerebral ischemic stroke or bleeding within 6 months prior screening * Organ transplantation or allogeneic hematopoietic stem cell transplantation history * Other surgery history within 6 weeks prior screening * Anti-tumor herbal medicine treatment within 4 weeks prior screening * Activated or uncontrolled hepatitis virus B infection (HBsAg positive with/or HBc Ab positive and HBV-DNA titration positive), hepatitis virus C antibody positive, HIV positive. * Uncontrolled active systemic fungal, bacterial, virus or other microbe infection, or intravenous injection of antibiotics needed * Accepted live vaccine or immunization within 4 weeks prior eligibility * Continuously taking drugs with medium / strong inhibition or induction of cytochrome P450 CYP3A is needed * Allergy to orelabrutinib or the subsidiary (or supplementary) material (Hydroxypropyl methylcellulose acetate succinate, mannitol, cross-linked sodium carboxymethylcellulose, hydroxypropyl cellulose, silica and magnesium stearate) * Obvious gastro-bowel disease which may influence the intaking, transportation or absorption of the drug, or total gastrectomy * Past or present pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, or drug-related pneumonia, with severe impairment of pulmonary function * Chronic liver damage, severe fatty liver or alcoholic liver disease * Intention to undergo autologous stem cell transplantation * Pregnant or breeding women, or women of childbearing age who are unwilling to take contraceptive measures during the whole study period and within 180 days after the last administration of the study drug; non surgically sterilized men who are unwilling to take contraceptive measures during the whole study period and within 180 days of the last administration of the study drug. * Potentially life-threatening situation, or severe organ dysfunction, or situations the researchers believe not suitable for the trial * Any mental or cognitive impairment which may limit the understanding and implementation of informed consent or the compliance with the study. * previously exposed with WBRT

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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.

Contacts and locations

Locations

  • Department of Hematology, Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200040, China

More trials for these conditions

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