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

Inclusion Criteria11

• 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.