Clinical trial

Zanubrutinib Monotherapy in Patients With Hemophagocytic Lymphohistiocytosis

Name
Zanubrutinib HLH
Description
This study is a prospective single-arm clinical study, focusing on Hemophagocytic lymphohistocytosis,to evaluate the clinical efficacy and safety of zanubrutinib.
Trial arms
Trial start
2022-02-01
Estimated PCD
2023-08-01
Trial end
2023-08-01
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
zanubrutinib
Size
16
Primary endpoint
evaluation of treatment response
Change from before and 2,4,6 and 8 weeks after initiating therapy
Progression Free Survival
6 months
Adverse events
6 months
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 16, 'type': 'ACTUAL'}}
Updated at
2024-04-11

1 organization

1 drug

1 indication