New cocktail of drugs takes on rare brain cancer
NCT ID NCT07350850
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests a combination of four drugs—pirtobrutinib, sintilimab, rituximab, and high-dose methotrexate—as a first treatment for adults with newly diagnosed primary central nervous system lymphoma (PCNSL). About 77 participants will choose either this experimental combo or standard therapy. The main goal is to see if the combo leads to more complete remissions. Researchers will also track side effects and survival for up to 2 years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pirtobrutinib, Sintilimab, Rituximab, and Methotrexate
- What this could lead to
- If successful, this combination could offer a more effective first-line treatment for primary CNS lymphoma, potentially improving response rates and survival.
- What could go wrong
- This is a phase 2 trial with only 77 participants, so results are preliminary. The combination may cause more side effects or not outperform standard therapy.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 77 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jun 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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18 years and older
- 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: 1. Age \>= 18 years. 2. Voluntarily signed informed consent. 3. ECOG Performance Status 0-3. 4. Expected survival \> 3 months. 5. Histopathologically confirmed Diffuse Large B-Cell Lymphoma (DLBCL) restricted to the CNS or eyes (PCNSL). 6. Measurable lesion on contrast-enhanced MRI (\>10x10 mm) or positive CSF cytology for leptomeningeal disease. 7. No prior systemic treatment for lymphoma (corticosteroids excepted). 8. Adequate bone marrow and organ function (ANC \>=1.5x10\^9/L, PLT \>=80x10\^9/L, Hb \>=80 g/L; Bilirubin \<=1.5xULN, AST/ALT \<=2.5xULN; Creatinine \<=1.5xULN or CrCl \>=60 mL/min) . 9. Stable controlled comorbidities allowed (e.g., hypertension with blood pressure \<=160/100 mmHg, type 2 diabetes with HbA1c \<=8%, mild coronary heart disease without myocardial infarction in the past 6 months). 10. Basic communication ability to complete PROs questionnaires (no severe cognitive impairment). 11. Reproductive-aged females and males with childbearing potential: No pregnancy plans during the study and 3 months after treatment discontinuation; use effective contraception (abstinence, physical contraception, or hormonal contraceptives initiated \>=3 months before first dose). Males prohibited from donating sperm during treatment and 3 months after discontinuation. 12. For Observational Cohort (Palliative Care Subgroup only): Pathologically confirmed DLBCL restricted to the CNS or eyes; Follow-up available for efficacy assessment (at least one CR evaluation) . Exclusion Criteria: 1.Prior treatment with PD-1/PD-L1 inhibitors or CTLA4 monoclonal antibodies. Uncontrolled active infection. 2.Uncontrolled or significant cardiovascular diseases: 3.Congestive heart failure (NYHA class III/IV), 1. myocardial infarction, unstable angina within 6 months before first dose; arrhythmia requiring treatment; LVEF \<50%. 2. Primary cardiomyopathy. 3. History of clinically significant QTc prolongation, second-degree type II/third-degree atrioventricular block, or QTc interval (Fridericia method) \>470 msec (females) / \>480 msec (males). 4. Atrial fibrillation (EHRA grade ≥2b). 5. Refractory hypertension. 4.Active hepatitis B/C infection (HBV-DNA ≥ detection limit, HCV RNA positive) or syphilis. (Exceptions: HBV-DNA \< detection limit, cured HCV). 5.HIV infection. 6.Prior organ transplantation or allogeneic stem cell transplantation. 7.Pregnant or lactating females. 8.Prior/current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, or radiation pneumonitis (unsuitable for study per investigator). 9.Autoimmune diseases requiring systemic treatment within 2 years. 10.For Observational Cohort (Palliative Care Subgroup only): Incomplete clinical data (e.g., no pathological report, inability to perform MRI/PET-CT assessment).
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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
4 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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China-Japan Union Hospital of Jilin University
RECRUITINGChangchun, Jilin, 130033, China
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Shanxi Provincial People's Hospital
NOT_YET_RECRUITINGTaiyuan, Shanxi, 030012, China
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The First Affiliated Hospital of Fujian Medical University
RECRUITINGXiamen, Fujian, China
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Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITINGWuhan, Hubei, 430000, China
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Other studies related to the condition(s) this trial covers.
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- Can a daily pill keep brain lymphoma at bay after remission?
- Can a Brain-Penetrating drug tackle recurrent CNS lymphoma?
- Digital tests may offer a new way to track brain health in tumor patients
- New antibody combo aims to treat brain lymphoma