New drug cocktail targets rare spleen cancer in early trial
NCT ID NCT07165769
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of three drugs (zanubrutinib, obinutuzumab, and lenalidomide) in people newly diagnosed with a rare type of lymphoma that affects the spleen. The goal is to see how well the treatment shrinks or controls the cancer and to check for side effects. About 47 adults aged 18 to 80 who have not had prior treatment for this lymphoma will take part.
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 47 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 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: * Aged 18 to 80 years, male or female * Histologically or cytologically confirmed SBLPN requiring active treatment; * No prior systemic therapy for SBLPN received; * ECOG performance status of 0-2; * Anticipated life expectancy ≥6 months; * Laboratory parameters (hematologic and biochemical) meeting the following criteria: * a. Absolute neutrophil count (ANC) ≥1.0 × 10⁹/L, platelet count ≥50 × 10⁹/L; * b. Total bilirubin (TBIL) ≤2.0 × upper limit of normal (ULN); * c. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; * d. Creatinine clearance ≥50 mL/min (calculated via Cockcroft-Gault formula or direct measurement). * Men and women of childbearing potential must agree to use medically approved contraception throughout the study and for 4 weeks after treatment discontinuation; * Participants must voluntarily enroll in the study and provide written informed consent. Exclusion Criteria: * History of central nervous system (CNS) disorders (including CNS lymphoma) diagnosed within 1 year prior to enrollment. * Other primary malignancies within the past 3 years (excluding non-melanoma skin cancer, curatively treated localized prostate cancer, cervical carcinoma in situ, or squamous intraepithelial lesions on PAP smear). * Exposure to any investigational drugs, antimicrobial agents, or participation in other interventional clinical trials within 4 weeks prior to enrollment. * Major surgery (excluding lymph node biopsy) within 14 days before enrollment or anticipated requirement for major surgery during the study. * Prior use of investigational agents targeting SBLPN. * Active immunodeficiency, autoimmune diseases, prolonged systemic corticosteroid therapy (\>10 mg/day prednisone equivalent) within 7 days prior to enrollment, or any immunosuppressive therapy. * Severe hepatic dysfunction (e.g., severe jaundice, hepatic encephalopathy, refractory ascites, hepatorenal syndrome), cachexia, multiorgan failure, or severe renal impairment. * Clinically significant cardiovascular comorbidities: New York Heart Association (NYHA) class III/IV heart failure; Myocardial infarction within 6 months prior to enrollment; Uncontrolled arrhythmias (including QTc interval ≥480 ms); Poorly controlled hypertension (systolic ≥150 mmHg/diastolic ≥100 mmHg despite antihypertensives); Unstable angina. * Bleeding diathesis or coagulation disorders; thrombotic events within 3 months prior to enrollment. * Hypersensitivity to active ingredients or excipients of the investigational drugs. * Pregnancy, lactation, or women of childbearing potential unwilling/unable to use contraception. * Other conditions deemed unsuitable for participation by the investigator (e.g., compromised protocol compliance or safety risks).
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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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Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
RECRUITINGTianjin, Tianjin Municipality, 300020, China