Zanubrutinib for HLH

NCT ID: NCT05320575

Last Updated: 2024-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-08-01

Brief Summary

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

Detailed Description

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Conditions

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HLH

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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zanubrutinib

Group Type EXPERIMENTAL

Zanubrutinib

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhao Wang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Friendship Hospital, Capital Medical University

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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Zanubrutinib HLH

Identifier Type: -

Identifier Source: org_study_id

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