Zanubrutinib for HLH

HLH Clinical Trial

Official title:

Zanubrutinib Monotherapy in Patients With Hemophagocytic Lymphohistiocytosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05320575
• Other study ID #: Zanubrutinib HLH
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: April 2024
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HLH

Intervention

Drug:
• Zanubrutinib
The dosage of zanubrutinib is 160mg twice a day (80mg twice a day for patients over 75 years old) for 2 months. The remission rate is evaluated after treatment. If it is above PR, continue the dose maintenance treatment.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluation of treatment response	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%.	Change from before and 2,4,6 and 8 weeks after initiating therapy
Primary	Progression Free Survival	from date of inclusion to date of progression, relapse, or death from any cause	6 months
Primary	Adverse events	Adverse events including myelosuppression, infection, hemorrhage	6 months