Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
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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