Golidocitinib (GO) treatment for hemophagocytic lymphohistiocytosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm Phase 2/3 trial of golidocitinib (GO) given alone to patients with primary or secondary HLH who meet molecular criteria or at least five of the HLH‑2004 diagnostic criteria. The protocol enrolls patients aged 14–70 who are currently unsuitable for allogeneic hematopoietic stem cell transplantation and who meet predefined organ‑function and infection‑screening limits. Efficacy will be measured by clinical and laboratory response rates and survival endpoints, while safety will be monitored by adverse events and cardiac and infectious screening. Detailed dosing and duration are not provided in the registry entry, and participants are treated at the single site in Beijing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Researchers evaluate patients with newly diagnosed or refractory/relapsed HLH disease.
2. Definite diagnosis of HLH: molecular diagnosis consistent with pHLH, or at least 5 of the 8 criteria in the HLH-2004 diagnostic criteria.
3. Patients who are currently unsuitable or unable to undergo allo-HSCT.
4. Researchers estimate that the expected survival period exceeds one month.
5. Patients must be at least 14 years of age and no older than 70 years of age, with no gender restrictions.
6. Before the study began, TB was ≤10 times the upper limit of normal; Cr was ≤1.5 times the normal value.
7. Serum HIV antigen or antibody negative。
8. HCV antibody negative, or HCV antibody positive but HCV RNA negative.
9. .HBsAg and HBcAb are both negative. If either of the above is positive, peripheral blood hepatitis B virus DNA titer testing is required, with a titer of less than 1×10³ copies/ml.
10. Echocardiography showed LVEF ≥ 50%.
11. Women of childbearing age must be confirmed as not pregnant by a pregnancy test and must be willing to use effective contraception during the study period and for at least 12 months after the last dose; all male participants must use contraception during the study period and for at least 3 months after the last dose.

Exclusion Criteria:

1. Heart function above grade II(including II) (NYHA).
2. Pregnancy or lactating Women and reproductive-age patients who refused to use appropriate contraceptive measures during this trial.
3. Individuals who are allergic to GO or have a severe allergic constitution.
4. Active bleeding of the internal organs.
5. uncontrollable infection.
6. Severe mental illness.
7. History of non-melanoma skin cancer.
8. Unable to comply during the trial and/or follow-up phase. Participate in other clinical research at the same time.

Where it's running

• beijing Friendship Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: zhao Wang — Beijing Friendship Hospital
• Study coordinator: jingshi Wang, M.M.
• Email: wangjingshi987@126.com
• Phone: 86-13520280731

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Golidocitinib versus placebo as maintenance for peripheral T-cell lymphoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.