New hope for tough brain cancer: Triple-Drug attack shows promise
NCT ID NCT05698147
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests a three-drug combination (selinexor, methotrexate, and rituximab) in 30 adults with central nervous system lymphoma that has relapsed or not responded to treatment. The goal is to find the safest dose and see how well the combo works. Participants receive the drugs in cycles, and those who improve may continue maintenance therapy for up to a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Selinexor (a drug that blocks a protein helping cancer cells survive), combined with methotrexate and rituximab (standard chemotherapy and targeted therapy)
- What this could lead to
- If successful, this could offer a new treatment option for people with central nervous system lymphoma that has come back or not responded to prior therapy.
- What could go wrong
- This is an early-phase trial with only 30 participants, so results may not apply to everyone. The drug combination may cause significant side effects, and the study is not designed to prove a cure.
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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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2023
- Expected to finish
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Dec 2026
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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18 to 75 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 inclusion criteria to be eligible to enroll in this study: 1. Participants must be able to understand and be willing to sign a written informed consent document. 2. Men and woman who are 18-75 years old on the day of consenting to the study. 3. Histologically documented PCNSL and SCNSL secondary to histologically documented systemic diffuse large B-cell lymphoma (DLBCL). 4. Patients must have relapsed/refractory PCNSL or relapsed/refractory SCNSL. 5. Patients must have response or remain stable disease for 2 months to prior methotrexate-based regimen. 6. Patients who had prior autologous hematopoietic stem cell transplantation are eligible. 7. Patients with parenchymal lesions must have unequivocal evidence of disease progression on imaging (MRI of the brain or head CT) 28 days prior to cycle1 day 1(C1D1). For patients with leptomeningeal disease only, CSF cytology must document lymphoma cells. 8. Participants must have an Eastern Cooperative Oncology Group performance status of 0-3. 9. Participants must have adequate bone marrow and organ function shown by: 1. Absolute neutrophil count (ANC) ≥ 1.0 x 10\^9/L 2. Platelets ≥ 75 x 10\^9/L and no platelet transfusion within the past 14 days prior to study registration c Hemoglobin (Hgb) ≥ 8 g/dL and no red blood cell (RBC) transfusion within the past 14 days prior to study registration 10. International Normalized Ratio (INR) ≤ 1.5 and PTT (aPTT) ≤ 1.5 times the upper limit of normal. 11. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal. 12. Serum bilirubin ≤ 1.5 times the upper limit of normal; or total bilirubin ≤ 3 times the upper limit of normal with direct bilirubin within the normal range in patients with well documented Gilbert Syndrome. 13. Calculated creatinine clearance(CrCl)≥50ml/min using the Cockcroft-Gault equation or 24-hour urine collection. 14. Life expectancy of \> 3 months. Exclusion Criteria: 1. Patients with SCNSL actively receiving treatment for extra-CNS disease are excluded. 2. Lymphoma patients with only intraocular involvement. 3. Pathological diagnosis of PCNSL is T-cell lymphoma. 4. Patients with disease progression within 6 months of prior methotrexate-containing regimen. 5. patients only had received stereotactic radiation therapy as prior treatment. 6. Patients have received chemotherapy, monoclonal antibodies or targeted anticancer therapy within 21 days or 5 half-lives, whichever is shorter, prior to C1D1. 7. Patients with active, unstable cardiovascular diseases, fits any of the following: 1. myocardial infarction within 6 months prior to the study enrollment 2. unstable angina within 3 months prior to the study enrollment 3. Uncontrolled clinically-significant conduction abnormalities (e.g., ventricular tachycardia, ventricular fibrillation, etc.) 4. Congestive heart failure (CHF) of New York Heart Association (NYHA) ≥ Grade 3 5. Echocardiography showing left ventricular ejection fraction less than 50% 8. Uncontrolled active infection within 1 week prior to the first dose of study drug. 9. Known active hepatitis B, or C infection or HIV infection; Note: Hepatitis B virus (HBV) surface antigen (HBsAg) and or hepatitis B core antibody-positive but undetectable HBV DNA or Hepatitis C virus (HCV) antibody positive but hepatitis C virus RNA undetectable are allowed. 10. Active GI dysfunction interfering with the ability to swallow tablets, or any GI dysfunction that could interfere with absorption of study treatment. 11. Prior exposure to a selective inhibitor of nuclear export(SINE) compound, including selinexor. 12. Serious, active psychiatric, or medical conditions which, in the opinion of the Investigator, could interfere with study treatment.
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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
5 sites. 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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Beijing Tiantan Hospital, Capital Medical University
NOT_YET_RECRUITINGBeijing, Beijing Municipality, China
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Department of Hematology, Huashan Hospital, Fudan University
RECRUITINGShanghai, Shanghai Municipality, 200040, China
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Oncology Department of The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITINGZhengzhou, Henan, 450052, China
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The First Affiliated Hospital Of Anhui Medical University
NOT_YET_RECRUITINGHefei, Anhui, China
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The First Affiliated Hospital Of Fujian Medical University
NOT_YET_RECRUITINGFuzhou, Fujian, China
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