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Zanubrutinib Combined With Rituximab in the Treatment of Secondary HLH in B-cell Lymphoma

ConditionsHemophagocytic LymphohistiocytosisB 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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Rituximab

    Drug

    375 mg/m², intravenously, once weekly for 4 weeks

  • Zanubrutinib

    Drug

    160 mg, orally, twice daily for 4 weeks as for rutuximab.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: intervention groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

response rate of HLH after 4 weeks of treatment

RR will be evaluated according to the response evaluation criteria recommended by the International Histiocyte Society.

Time frame
after 4 weeks
2

OS at week 8

overall survival after 8 weeks of treatment

Time frame
after 8 weeks

Secondary outcomes

1

AE

Adverse events will be evaluated according to NCI-CTCAE 5.0.

Time frame
till the end of 4 weeks
2

OS

OS at 1/2/3 months/ 6 months

Time frame
at 4/8/12/24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Soochow University

Lead sponsor

Source ClinicalTrials.gov
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