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

NCT ID: NCT07339345

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-27
• Study Completion Date: 2027-06-27

Brief Summary

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

Conditions

Lymphohistiocytosis, Hemophagocytic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HLH patients

Initial diagnosis or presence of refractory/relapsed HLH disease or confirmed diagnosis of HLH.

Group Type: EXPERIMENTAL

Golidocitinib

Intervention Type: DRUG

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

Interventions

Golidocitinib

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Wang

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

zhao Wang

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

jingshi Wang, M.M.

Role: CONTACT

wangjingshi987@126.com

86-13520280731

Facility Contacts

jingshi Wang, M.M.

Role: primary

wangjingshi987@126.com

86-13520280731

Other Identifiers

Golidocitinib(GO),HLH

Identifier Type: -

Identifier Source: org_study_id