Recruiting NCT07339345

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

Phase II / Phase III Interventional Lymphohistiocytosis, Hemophagocytic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Golidocitinib.
Who it may be relevant to: Registry conditions: Lymphohistiocytosis, Hemophagocytic. Basic parameters: 14 years — 70 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

Prospective Single-Arm Clinical Trial of Golidocitinib Monotherapy for Hemophagocytic Lymphohistiocytosis.

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

Drug Golidocitinib
Administer the GO regimen to HLH patients who meet the inclusion criteria, specifically Golicitinib 150 mg once daily.

Evaluation of treatment response [Time frame: Weeks 2, 4, 6, and 8 after the start of treatment]

Secondary outcome measures (1)

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time frame: 30 days after the last dose is administered.]

Researchers evaluate patients with newly diagnosed or refractory/relapsed HLH disease.
Definite diagnosis of HLH: molecular diagnosis consistent with pHLH, or at least 5 of the 8 criteria in the HLH-2004 diagnostic criteria.
Patients who are currently unsuitable or unable to undergo allo-HSCT.
Researchers estimate that the expected survival period exceeds one month.
Patients must be at least 14 years of age and no older than 70 years of age, with no gender restrictions.
Before the study began, TB was ≤10 times the upper limit of normal; Cr was ≤1.5 times the normal value.
Serum HIV antigen or antibody negative。
HCV antibody negative, or HCV antibody positive but HCV RNA negative.
.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.
Echocardiography showed LVEF ≥ 50%.
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.

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

China · 1 center

NCT: NCT07339345 · Golidocitinib(GO),HLH