Zanubrutinib for HLH

Capital Medical University

Status and phase: Completed; Phase 3

Conditions: HLH

Treatments: Drug: Zanubrutinib

Study type: Interventional

Funder types: Other

Identifiers

NCT05320575

Zanubrutinib HLH

Details and patient eligibility

About

This study is a prospective single-arm clinical study, focusing on Hemophagocytic lymphohistocytosis，to evaluate the clinical efficacy and safety of zanubrutinib.

Enrollment: 16 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Unlimited gender, age ≥ 14 years old;
2. HLH was diagnosed according to HLH-04 diagnostic criteria;
3. Before the study, there was no severe liver function injury; Serum creatinine ≤ 1.5 times the upper limit of normal value;
4. Sign informed consent

Exclusion criteria

1. Allergic to zebutinib;
2. Currently active important cardiovascular diseases with clinical significance; The functions of important organs such as heart and lung unrelated to HLH were seriously abnormal;
3. Known human immunodeficiency virus (HIV) or active hepatitis B (HBV) or hepatitis C (HCV) infection;
4. Pregnant or lactating women and patients of childbearing age who refuse to take appropriate contraceptive measures during this trial;
5. Serious mental illness;
6. Active massive hemorrhage of internal organs;
7. Uncontrollable infection;
8. At the same time, participate in other clinical researchers

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

zanubrutinib

Experimental group

Treatment:

Drug: Zanubrutinib