Can a targeted drug combo outsmart brain lymphoma?
NCT ID NCT05036577
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 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: * 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Primary central nervous system lymphoma are added.
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.
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.
- Can an immune booster outsmart brain lymphoma?
- Can a daily pill keep brain lymphoma at bay after remission?
- Can a Brain-Penetrating drug tackle recurrent CNS lymphoma?
- New antibody combo aims to treat brain lymphoma
- Could a cancer drug shrink recurrent brain tumors?
- New cocktail aims to shrink brain tumors