Actively Recruiting

Phase 2
Phase 3
Age: 14Years - 70Years
All Genders
NCT07339345

Prospective Single-Arm Clinical Trial of GO Regimen for HLH.

Led by Beijing Friendship Hospital · Updated on 2026-01-14

28

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to investigate the efficacy and safety of Golidocitinib(GO) monotherapy in the treatment of hemophagocytic lymphohistiocytosis.

CONDITIONS

Official Title

Prospective Single-Arm Clinical Trial of GO Regimen for HLH.

Who Can Participate

Age: 14Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with newly diagnosed or relapsed/refractory HLH disease
  • Confirmed HLH diagnosis by molecular diagnosis or at least 5 of 8 HLH-2004 criteria
  • Currently unsuitable or unable to undergo allogeneic hematopoietic stem cell transplantation
  • Expected survival period longer than one month
  • Aged between 14 and 70 years, any gender
  • Total bilirubin no more than 10 times the upper limit of normal before study
  • Creatinine no more than 1.5 times the normal value before study
  • Serum HIV antigen and antibody negative
  • Hepatitis C antibody negative, or positive but HCV RNA negative
  • Negative for HBsAg and HBcAb, or hepatitis B virus DNA less than 1×10³ copies/ml if positive
  • Left ventricular ejection fraction (LVEF) at least 50% by echocardiography
  • Women of childbearing age must have negative pregnancy test and agree to use effective contraception during study and for 12 months after last dose; male participants must use contraception during study and for 3 months after last dose
Not Eligible

You will not qualify if you...

  • Heart function at or above grade II (NYHA classification)
  • Pregnancy, lactation, or refusal to use contraception during the trial
  • Allergy to Golidocitinib or history of severe allergic reactions
  • Active bleeding of internal organs
  • Uncontrolled infections
  • Severe mental illness
  • History of non-melanoma skin cancer
  • Inability to comply with trial or follow-up requirements
  • Participation in other clinical research simultaneously

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100050

Actively Recruiting

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Research Team

J

jingshi Wang, M.M.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Prospective Single-Arm Clinical Trial of GO Regimen for HLH. | DecenTrialz