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

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT07270835
Phase
PHASE4
Status
Recruiting
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Conditions

  • B Cell Lymphoma
  • Hemophagocytic Lymphohistiocytosis

Eligibility Criteria

Sex
ALL
Age
14 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    375 mg/m², intravenously, once weekly for 4 weeks
  • Zanubrutinib — DRUG
    160 mg, orally, twice daily for 4 weeks as for rutuximab.

Study Details

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.

Key Dates

Start date
Nov 1, 2025
Status verified
Nov 2025
Primary completion
Apr 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: intervention group
    Rituximab 375 mg/m², intravenously, once weekly for 4 weeks (may be extended or adjusted according to clinical response). Zanubrutinib: 160 mg, orally, twice daily for 4 weeks as for rutuximab. Dose can be adjusted or extended according to tolerance and efficacy. When ≥3 grade hematological or intolerable non-hematological toxicity occur, zanubrutinib or rituximab will be suspended, and the dose will be reduced or resumed according to the toxicity grade after recovery. The dose of zanubrutinib should be adjusted according to the manufacturer's label with concomitant use of strong CYP3A inhibitor/inducer. Combined drugs: prednisone 100 mg/m²/d, orally, d1-5; Ruxolitinib 15mg bid orally; With/without emapalumab as appropriate.

Primary Outcome Measure

response rate of HLH after 4 weeks of treatment [ Time Frame: after 4 weeks ]

Central Contacts

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