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This study aims to investigate the efficacy and safety of Golidocitinib(GO) monotherapy in the treatment of hemophagocytic lymphohistiocytosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HLH patients | Experimental | Initial diagnosis or presence of refractory/relapsed HLH disease or confirmed diagnosis of HLH. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Golidocitinib | Drug | Administer the GO regimen to HLH patients who meet the inclusion criteria, specifically Golicitinib 150 mg once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of treatment response | A complete response was defined as normalization of all of the quantifiable symptoms and laboratory markers of HLH, including levels of sCD25, ferritin, triglyceride, blood cell count, hemophagocytosis, and level of consciousness (if CNS HLH is present). A partial response was defined as at least a 25% improvement in 2 or more quantifiable symptoms and laboratory markers as follows: sCD25 response was>1.5-fold decreased; ferritin and triglyceride decreased at least 25%; without blood transfusion: Neutrophils <500/ml must increase by 100% and be >500/ml; neutrophils 500-2000/ml must increase by 100% and return to normal.; and for patients with ALT >400 U/L, response was defined as an ALT decrease of at least 50%. No response is defined as not meeting the criteria for partial response. | Weeks 2, 4, 6, and 8 after the start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | An adverse event is defined as an adverse medical condition (including worsening of a pre-existing condition) that occurs in a subject or clinical trial subject after receiving medication, regardless of whether it is causally related to the investigational drug. Serious adverse events are defined as AEs that meet one or more of the following criteria during any study period: death; immediate threat to life; and hospitalization or prolongation of hospitalization. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Patient's HLH-related symptoms and auxiliary examination results | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jingshi Wang, M.M. | Contact | 86-13520280731 | wangjingshi987@126.com |
| Name | Affiliation | Role |
|---|---|---|
| zhao Wang | Beijing Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| beijing Friendship Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100050 | China |
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| ID | Term |
|---|---|
| D051359 | Lymphohistiocytosis, Hemophagocytic |
| ID | Term |
|---|---|
| D015616 | Histiocytosis, Non-Langerhans-Cell |
| D015614 | Histiocytosis |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| 30 days after the last dose is administered. |