Zanubrutinib Combined With Rituximab in the Treatment of Secondary HLH in B-cell Lymphoma (NCT07270835) | Clinical Trial Compass
RecruitingPhase 4
Zanubrutinib Combined With Rituximab in the Treatment of Secondary HLH in B-cell Lymphoma
China40 participantsStarted 2025-11-01
Plain-language 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.
Who can participate
Age range14 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 1Ă—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 inhib…
What they're measuring
1
response rate of HLH after 4 weeks of treatment
Timeframe: after 4 weeks
2
OS at week 8
Timeframe: after 8 weeks
Trial details
NCT IDNCT07270835
SponsorThe First Affiliated Hospital of Soochow University