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This study aimed to investigate the efficacy and safety of DEP (liposomal doxorubicin, etoposide and methylprednisolone) together with PD-1 antibody as an treatment for EBV associated hemophagocytic lymphohistiocytosis.
PD-1 antibody added to the DEP regimen （with or without asparaginases） in EBV-HLH,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEP combine with PD-1 antibody | Experimental | doxorubicin (doxorubicin hydrochloride liposome injection) 25 mg/m2 day 1; etoposide 100 mg/m2 was administered day1; methylprednisolone 1.5mg/kg days 1 to 3,then 0.25mg/kg day 4 to 14; sintilimab injection 200mg day 4. This regimen was repeated after 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEP combine with PD-1 antibody | Drug | Doxorubicin hydrochloride liposome injection 25 mg/m2 day 1 Etoposide 100 mg/m2 day1 Methylprednisolone 1.5 mg/kg days 1 to day 3, 0.25mg/kg days 4 to 14 Sintilimab Injection 200mg d4 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of treatment response | The primary observed endpoint is the objective remission rate (ORR): cases that include complete remission (CR) and partial remission (PR).CR was defined as normalization of all of the quantifiable symptoms and laboratory markers of HLH, including levels of sCD25, ferritin, and triglyceride; hemoglobin; neutrophil counts; platelet counts; and alanine aminotransferase (ALT). PR 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%; for patients with an initial neutrophil count of<0.5 ×109/L, a response was defined as an increase by at least 100% to>0.5× 109/L; for patients with a neutrophil count of 0.5 to 2.0 × 109/L, an increase by at least 100% to >2.0 × 109/L was considered a response; and for patients with ALT >400 U/L, response was defined as an ALT decrease of at least 50%. | Change from before and 2,4,6 and 8 weeks after initiating DEP combine with PD-1 antibody therapy |
| Measure | Description | Time Frame |
|---|---|---|
| EBV-DNA | EBV-DNA copies/ml in peripheral blood | Change from before and 2,4,6 and 8 weeks after initiating DEP combine with PD-1 antibody therapy |
| Survival | Outcome of patients with EBV-HLH |
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Inclusion Criteria:
8. Informed consent obtained.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhao Wang | Contact | 86-010-63139862 | wangzhao@ccmu.edu.cn | |
| Yahong You | Contact | 17810283962 | 15332022659@163.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 | 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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All patients with EBV- HLH receive DEP combine with PD-1 antibody as an treatment.
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|
| 3 months after the intervention |
| Adverse events that are related to treatment | Incidence of events that are related to treatment including myelosuppression, infection, bleeding and so on. | 2,4,6 and 8 weeks after initiating DEP combine with PD-1 antibody therapy |