Zanubrutinib for HLH

Phase 3CompletedNCT05320575

Beijing Friendship Hospital16 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HLH

Interventions

ZanubrutinibDRUG

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.

Eligibility

Sex: ALLMin age: 14 Years

Medical Language ↔ Plain English

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

Locations (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Outcomes

Primary Outcomes

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%.

Time frame: Change from before and 2,4,6 and 8 weeks after initiating therapy

Progression Free Survival

from date of inclusion to date of progression, relapse, or death from any cause

Time frame: 6 months

Adverse events

Adverse events including myelosuppression, infection, hemorrhage

Time frame: 6 months

Data from ClinicalTrials.gov

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