Zanubrutinib for HLH

NCT05320575 | Completed Phase 3

• 1 other identifier: Zanubrutinib HLH
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HLH

Outcome Measures

Primary Outcomes (3)

• 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

• Progression Free Survival

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

  6 months

• Adverse events

  Adverse events including myelosuppression, infection, hemorrhage

  6 months

Study Arms (1)

zanubrutinib

EXPERIMENTAL

Drug: Zanubrutinib

Interventions

Zanubrutinib DRUG

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.

zanubrutinib

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Location

MeSH Terms

Interventions

zanubrutinib

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 2, 2022
• First Posted: April 11, 2022
• Study Start: February 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

CN (1)