Zanubrutinib for HLH

Phase 3

Completed

• Conditions: HLH
• Interventions: Drug: Zanubrutinib

• Registration Number: NCT05320575
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2022-04-02
• Study First Submitted QC: 2022-04-02
• Study First Posted: 2022-04-11
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
zanubrutinib	Zanubrutinib	-

Primary Outcome Measures

Name	Time	Method
evaluation of treatment response	Change from before and 2,4,6 and 8 weeks after initiating therapy	A complete response was defined as normalization of all of the quantifiable symptoms and laboratory markers of HLH, including levels of sCD25, ferritin, and triglyceride; hemoglobin; neutrophil counts; platelet counts; and alanine aminotransferase (ALT).; A partial response was defined as at least a 25% improvement in 2 or more quantifiable symptoms and laboratory markers as follows: sCD25 response was\>1.5-fold decreased; ferritin and triglyceride decreased at least 25%; for patients with an initial neutrophil count of\<0.5 ×109/L, a response was defined as an increase by at least 100% to\>0.5×109/L; for patients with a neutrophil count of 0.5 to 2.0× 109/L, an increase by at least 100% to \>2.0 × 109/L was considered a response; and for patients with ALT \>400 U/L,response was defined as an ALT decrease of at least 50%.
Adverse events	6 months	Adverse events including myelosuppression, infection, hemorrhage
Progression Free Survival	6 months	from date of inclusion to date of progression, relapse, or death from any cause

Trial Locations

Locations (1)

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, China