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New targeted drug may improve lymphoma treatment
NCT ID NCT07372365
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new approach for people with untreated marginal zone lymphoma, a slow-growing blood cancer. Participants first get a short course of standard chemotherapy, then a targeted drug called orelabrutinib to keep the cancer under control. The goal is to see if this combination improves response rates and delays the cancer's return. About 23 people will take part, and they will be closely monitored for side effects and treatment success.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Orelabrutinib (a targeted drug) combined with R-CHOP chemotherapy and rituximab
- What this could lead to
- If successful, this could offer a more effective and less toxic treatment plan for people with newly diagnosed marginal zone lymphoma, potentially improving long-term disease control.
- What could go wrong
- This is a small, early-phase study with only 23 participants, so results may not apply to everyone. The drug may cause side effects, and the treatment may not work better than current options.
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 23 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 2030
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. Histologically confirmed CD20-positive marginal zone lymphoma (MZL) that has not received systemic therapy. 2. MZL that has progressed or relapsed after prior local therapy (local therapy includes surgery, radiotherapy, Helicobacter pylori eradication, and hepatitis C treatment) or is not amenable to local therapy. 3. Age ≥18 years. 4. Presence of an indication for treatment as determined by the investigator or patient's willingness to receive treatment. 5. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2. 6. Adequate organ function as defined below: * Hematology: Hemoglobin (HB) ≥60 g/L, platelets (PLT) ≥50×10⁹/L, neutrophils (NE) ≥1.0×10⁹/L (Note: Subjects with cytopenia due to lymphoma bone marrow involvement are not restricted by this criterion). * Cardiac: Left ventricular ejection fraction (LVEF) ≥50% as determined by echocardiogram. * Renal: Creatinine ≤1.5×upper limit of normal (ULN) or creatinine clearance ≥30 ml/min. * Hepatic: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3×ULN. 7. Women of childbearing potential must have a negative pregnancy test. Both male and female patients must agree to use effective contraception during the treatment period and for 2 years thereafter. 8. Life expectancy of more than 3 months. 9. Voluntary provision of written informed consent. Exclusion Criteria: 1. Underwent major surgery or severe trauma within 2 weeks prior to enrollment, or has not yet recovered from significant adverse effects. 2. Has other malignancies currently or within the past 3 years, excluding those that have been cured (such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, prostatic intraepithelial neoplasia, and cervical carcinoma in situ). 3. Has a history of stroke or intracranial hemorrhage within the past 3 months. 4. Requires anticoagulation with warfarin or equivalent vitamin K antagonist. 5. Has evidence of any comorbidities or medical conditions that may interfere with the conduct of the study or place the patient at significant risk, including but not limited to severe cardiovascular disease (e.g., New York Heart Association class III or IV heart disease, myocardial infarction within the past 6 months, unstable arrhythmia, or unstable angina) and/or severe pulmonary disease (e.g., severe obstructive pulmonary disease and a history of symptomatic bronchospasm). 6. Is infected with human immunodeficiency virus, or has uncontrollable active hepatitis C virus or hepatitis B virus infection. 7. Has uncontrollable active infection. 8. Is pregnant or breastfeeding. 9. Has any life-threatening disease, medical condition, or organ dysfunction that may jeopardize the safety of the patient, as determined by the investigator. 10. Has any condition that may interfere with the absorption or metabolism of orelabrutinib or place the study results at unnecessary risk. 11. Has central nervous system involvement by marginal zone lymphoma or evidence of disease transformation. 12. Has any condition that the investigator judges may interfere with the patient's full participation in the study; any condition that poses significant risk to the patient; or any condition that may interfere with the interpretation of study data.
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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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The First Affiliated Hospital of Soochow University
RECRUITINGSuzhou, Jiangsu, 215000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- CAR-T therapy Follow-Up study shows no new safety surprises
- New Risk-Adapted drug combo aims to outsmart lymphoma
- New combo therapy aims to shrink lymphoma tumors in untreated patients
- New combo therapy aims to wipe out lymphoma without prior treatment