NCT07270835 Zanubrutinib Combined With Rituximab in the Treatment of Secondary HLH in B-cell Lymphoma
| NCT ID | NCT07270835 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Condition | Hemophagocytic Lymphohistiocytosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2025-11-01 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * According to the diagnostic criteria of HLH-04, the patients meet the diagnostic criteria of HLH; * HLH patients with definite or highly suspected evidence of B-cell lymphoma; Or HLH patients whose bone marrow flow cytometry show an increased proportion of CD20-positive B cells; * Age of 14-80 years old, both sexes; * Predicted survival beyond 1 month; * Baseline serum creatinine ≤1.5 times ULN; Fibrinogen could be corrected to ≥0.6g/L by infusion; * Negative serum HIV antibody; Either negative for HCV antibodies or positive for HCV antibodies but negative for HCV RNA. HBV surface antigen and HBV core antibody were negative. If any of the above was positive, HBV DNA titer in peripheral blood should be tested, and the titer was less than 1×10\^3 copies /ml; * Left ventricular ejection fraction (LVEF) ≥50% measured by echocardiography; * The patient have no serious and uncontrollable infections, such as pulmonary infection, intestinal infection, and sepsis; * Women of childbearing age must be confirmed to be not pregnant by pregnancy test and willing to take effective measures to prevent pregnancy during the study period and ≥12 months after the last dose; Pregnant and lactating women cannot participate; All male subjects took contraceptive measures during the trial and ≥3 months after the last dose; * Patients should be able to sign informed consent. Exclusion Criteria: * Patients with 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 including NYHA class III-IV heart failure or severe arrhythmia; Liver function: ALT or AST \>5 times the upper limit, or severe cirrhosis; Renal function: CrCl \<30 mL/min or severe renal insufficiency; * Combined with other malignant tumors and the expected survival time was less than 3 months; * Have received other experimental drugs and had not completed the drug washout period; * Pregnant or lactating women, or unwilling to use effective contraception; * any condition that would not be suitable for participation in the study or that might affect adherence, follow-up, or safety assessment, as judged by the investigator.
Contact & Investigator
Xuefeng He, doctor
PRINCIPAL INVESTIGATOR
department of hematology, The First Affiliated Hospital of Soochow University
Frequently Asked Questions
Who can join the NCT07270835 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 80 Years, studying Hemophagocytic Lymphohistiocytosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07270835 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07270835 currently recruiting?
Yes, NCT07270835 is actively recruiting participants. Contact the research team at hexuefeng@suda.edu.cn for enrollment information.
Where is the NCT07270835 trial being conducted?
This trial is being conducted at Suzhou, China.
Who is sponsoring the NCT07270835 clinical trial?
NCT07270835 is sponsored by The First Affiliated Hospital of Soochow University. The principal investigator is Xuefeng He, doctor at department of hematology, The First Affiliated Hospital of Soochow University. The trial plans to enroll 40 participants.