Actively Recruiting
Zanubrutinib Combined With Rituximab in the Treatment of Secondary HLH in B-cell Lymphoma
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-12-08
40
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
For patients who met the inclusion criteria, treatment regimens were administered: Rituximab 375 mg/m², intravenously, once weekly for 4 weeks. Zanubrutinib 160 mg, orally, twice daily for 4 weeks. Combined drugs: prednisone 100 mg/m²/d, orally, d1-5; Ruxolitinib 15mg bid orally; With/without emapalumab as appropriate.
CONDITIONS
Official Title
Zanubrutinib Combined With Rituximab in the Treatment of Secondary HLH in B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients meet the diagnostic criteria for HLH based on HLH-04 guidelines
- HLH patients with confirmed or highly suspected B-cell lymphoma or increased CD20-positive B cells in bone marrow
- Age between 14 and 80 years, any gender
- Predicted survival longer than 1 month
- Baseline serum creatinine less than or equal to 1.5 times the upper normal limit
- Fibrinogen levels correctable to 0.6 g/L or higher by infusion
- Negative for HIV antibodies; negative for HCV antibodies or positive HCV antibodies with negative HCV RNA
- Negative for HBV surface antigen and core antibody; if positive, HBV DNA below 1 x 10^3 copies/ml
- Left ventricular ejection fraction (LVEF) of 50% or higher by echocardiography
- No serious or uncontrolled infections such as lung, intestinal infections, or sepsis
- Women of childbearing age must have a negative pregnancy test and agree to effective contraception during the study and for 12 months after last dose
- Male participants agree to use contraception during the study and for 3 months after last dose
- Ability to provide informed consent
You will not qualify if you...
- Known severe allergy to rituximab, zanubrutinib, or other BTK inhibitors
- Severe active infections including bacterial, viral, or fungal infections or uncontrolled co-infections
- Severe organ dysfunction such as NYHA class III-IV heart failure or severe arrhythmia
- Liver function with ALT or AST greater than 5 times the upper limit or severe cirrhosis
- Severe renal insufficiency with creatinine clearance less than 30 mL/min
- Other malignant tumors with expected survival less than 3 months
- Use of other experimental drugs without completion of washout period
- Pregnant or lactating women or unwillingness to use effective contraception
- Any condition that may affect study participation, adherence, follow-up, or safety as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
Research Team
X
Xuefeng He, doctor
CONTACT
F
Fei Zhou, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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