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Completed

NCT Number: NCT05320575

Zanubrutinib for HLH

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

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Key information

Conditions

HLH

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. evaluation of treatment response

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

    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%.

  2. Progression Free Survival

    Time frame: 6 months

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

  3. Adverse events

    Time frame: 6 months

    Adverse events including myelosuppression, infection, hemorrhage

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Official study title

Zanubrutinib Monotherapy in Patients With Hemophagocytic Lymphohistiocytosis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 11, 2022
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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