Zanubrutinib Combined With Rituximab in the Treatment of Secondary HLH in B-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age14-80
SponsorThe First Affiliated Hospital of Soochow University
About this trial
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
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Rituximab
- Zanubrutinib
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov