New cocktail of cancer drugs shows promise for tough brain tumors
NCT ID NCT07191431
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of three drugs—orelabrutinib, selinexor, and a chemotherapy drug—in 25 people with relapsed or refractory central nervous system lymphoma, a type of brain cancer. The goal is to see if this mix can shrink tumors better than current treatments. Participants will receive the drugs in cycles over 18 weeks, with possible maintenance therapy. This is an early-stage trial, so the main focus is safety and effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Orelabrutinib, selinexor, and methotrexate (or alternatives thiotepa or temozolomide)
- What this could lead to
- If successful, this could offer a new treatment option for patients with hard-to-treat brain lymphoma, potentially improving response rates.
- What could go wrong
- This is a very small early trial with only 25 participants, so results may not apply broadly. The drug combo has significant side effects, and long-term benefits are unknown.
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
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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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
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14 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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: * Patients must meet all of the following criteria to be enrolled in this study: * Fully understand this study and voluntarily sign the informed consent form; * Age: 14-80 years; * Life expectancy judged by the investigator to exceed 3 months; * B-cell origin central nervous system lymphoma (CNSL) confirmed by pathology or flow cytometry (histology or cytology); * Relapsed or refractory PCNSL or SCNSL: Must have received at least one prior systemic therapy for CNS lesions; number of relapses is not restricted; * Any non-hematological toxicity related to prior treatment should have recovered to Grade 1 or normal (according to NCI CTCAE version 5.0, except alopecia). * Bone marrow and organ function meeting the following criteria (no transfusion, no G-CSF use, no medication for correction within 14 days before screening): Bone marrow function: Absolute neutrophil count ≥1.0x10⁹/L, platelets ≥50x10⁹/L, hemoglobin ≥60g/L;Liver function: Serum total bilirubin ≤1.5xULN (≤3.0xULN if liver metastases present); AST and ALT ≤ 2.5xULN (≤5.0xULN if liver metastases present);Coagulation function: International Normalized Ratio (INR) and activated partial thromboplastin time ≤1.5xULN;Renal function: Serum creatinine ≤1.5xULN or estimated creatinine clearance ≥30 mL/min (Male: Cr (mL/min) = (140 - age) x weight (kg) / (72 x serum creatinine (mg/dL)); Female: Cr (mL/min) = (140 - age) x weight (kg) / (85 x serum creatinine (mg/dL))). * Female subjects of childbearing potential and male subjects with reproductive ability, who have no pregnancy plan with their partners during the study period and for 3 months after treatment interruption, must use one of the following effective contraceptive methods throughout the study and for 3 months after treatment interruption: abstinence, physical contraception (e.g., ligation, condoms, etc.), hormonal contraceptive drugs started at least 3 months before the first dose in the study. Male subjects are prohibited from sperm donation from the start of treatment until 3 months after treatment cessation. The patient or their legal guardian voluntarily signs the informed consent form. * Good compliance, willing to adhere to the visit schedule, dosing plan, laboratory tests, and other trial procedures. Exclusion Criteria: * Patients who meet any of the following criteria will not be allowed to enter this study: * Contraindication to any drug in the treatment regimen; * Subject has a history of active liver disease, including viral or other hepatitis or cirrhosis (Hepatitis B defined as HBV-DNA above the upper limit of normal; active Hepatitis C defined as seropositive for HCV antibody, but those with negative HCV-RNA can be enrolled); * Human Immunodeficiency Virus (HIV) infection; * Congestive heart failure (New York Heart Association Class \>2); history of acute myocardial infarction, unstable angina, stroke, or transient ischemic attack within the past six months; * Hereditary long QT syndrome or QTc \>480ms (Note: QTc interval must be calculated using Fridericia's formula, QTcF = QT/(RR)\^0.33); * Pregnant and lactating women, or those planning to become pregnant during the study period; * Clear history of neurological or psychiatric disorders, or history of psychotropic drug abuse or drug addiction; * Clinically significant active infection.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITINGShanghai, Shanghai Municipality, China
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