New combo therapy aims to wipe out lymphoma without prior treatment
NCT ID NCT07480863
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of three drugs (orelabrutinib, zuberitamab, and chemotherapy) in 65 adults with untreated marginal zone lymphoma, a slow-growing blood cancer. The goal is to see if the treatment can make all signs of cancer disappear for at least 24 months. Participants must be 18 or older, in good general health, and have measurable tumors.
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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 65 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Oct 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 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: * Age 18 years or older * ECOG performance status (PS) 0-2 * Expected survival of at least 12 weeks * CD20-positive marginal zone lymphoma confirmed according to WHO 2022 lymphoma classification standards, including the three subtypes: nodal MZL, extranodal MZL, and splenic MZL * Measurable lesions by contrast-enhanced computed tomography/magnetic resonance imaging (CT/MRI) * Meet the NCCN guideline criteria for MZL treatment and have not previously received systemic therapy for MZL (excluding hormone therapy and anti-infective treatment) * Main organ function within normal limits, meeting the following criteria (excluding abnormalities caused by lymphoma): 1. Hematology test standards: 1. ANC ≥ 1.0 × 10\^9/L 2. PLT ≥ 75 × 10\^9/L (for patients with confirmed bone marrow involvement: ≥ 50 × 10\^9/L) 3. Hb ≥ 80 g/L 2. Biochemistry test standards: 1. TBIL \< 2 × ULN 2. ALT and AST \< 2.5 × ULN (for patients with liver involvement, ALT and AST \< 5 × ULN) 3. Endogenous creatinine clearance ≥ 40 ml/min (Cockcroft-Gault formula) * Women of childbearing potential must use reliable contraception or have a negative pregnancy test (blood or urine) within 7 days prior to enrollment and agree to use appropriate contraception during the trial and for 8 weeks after the last dose of the study drug. For men, agreement to use appropriate contraception during the trial and for 8 weeks after the last dose of the study drug or previous surgical sterilization is required * Subjects voluntarily agree to participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up Exclusion Criteria: * Patients with central nervous system involvement * Patients with a history of or concurrent untreated malignant tumors, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and superficial bladder cancer * Patients with the following cardiovascular diseases: myocardial ischemia or myocardial infarction of grade II or above, uncontrolled arrhythmias (including QTc interval ≥450 ms for men, ≥470 ms for women); heart failure of NYHA class III-IV, or left ventricular ejection fraction (LVEF) \<50% as indicated by cardiac ultrasonography; 4. Coagulation dysfunction (INR \>1.5 or prothrombin time (PT) \> ULN + 4 seconds, or APTT \>1.5 ULN), bleeding tendency, or currently receiving thrombolytic or anticoagulant therapy * Arterial or venous thrombotic events occurring within 12 months prior to enrollment, such as cerebrovascular events (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, or pulmonary embolism * Known genetic or acquired bleeding or thrombotic disorders (e.g., hemophilia, coagulation disorders) * Major surgery or severe traumatic injury, fracture, or ulceration within 4 weeks prior to enrollment * Factors significantly affecting oral drug absorption, such as dysphagia, chronic diarrhea, or intestinal obstruction * Active infections requiring antimicrobial treatment (e.g., antibacterial or antiviral drugs, excluding chronic hepatitis B antiviral therapy or antifungal treatments); 10. Active hepatitis B (HBV DNA ≥2000 IU/mL or 104 copies/mL) or hepatitis C (HCV antibody positive and HCV RNA above the detection limit of the assay) * History of substance abuse of psychiatric drugs that cannot be discontinued or mental disorders * Participation in another anti-tumor drug clinical trial within 4 weeks prior to enrollment * Treatment with strong CYP3A4 inhibitors within 7 days prior to enrollment, or treatment with strong CYP3A4 inducers within 12 days prior to enrollment * Pregnant or breastfeeding women; patients of childbearing potential who are unwilling or unable to use effective contraception * Other conditions that the investigator deems may affect the conduction of the clinical study or the assessment of study results
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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
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Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, beijing,
Beijing, China
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Other studies related to the condition(s) this trial covers.
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