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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05315336
Other study ID # L-DEP, PD-1, HLH
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date June 1, 2022
Est. completion date June 1, 2026

Study information

Verified date April 2022
Source Beijing Friendship Hospital
Contact Zhao Wang
Phone 86-010-63139862
Email wangzhao@ccmu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aimed to investigate the efficacy and safety of L-DEP (L-Asparaginasum, liposomal doxorubicin, etoposide and methylprednisolone) together with PD-1 antibody as an treatment for relapse/refractory EBV associated hemophagocytic lymphohistiocytosis.


Description:

PD-1 antibody added to the DEP regimen (with or without asparaginases) in EBV-HLH


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date June 1, 2026
Est. primary completion date June 1, 2025
Accepts healthy volunteers No
Gender All
Age group 1 Year to 70 Years
Eligibility Inclusion Criteria: 1. Meet hemophagocytic lymphohistiocytosis (HLH)-04 diagnostic criteria;patients were diagnosed with EBV associated HLH (EBV-HLH). 2. EBV-DNA in peripheral blood or EBER in tissue were positive. 3. Treated with HLH-94 no less than 2 weeks before enrollment and did not achieve at least partial response 4. The patient is expected to be unable to undergo allogeneic hematopoietic stem cell transplantation in the short term due to various reasons (physical status, economic reasons, donor reasons, etc.) 5. The expected survival time is more than 1 month. 6. Age = years old, gender is not limited. 7. Serum creatinine = 1.5 times normal;After infusion, fibrinogen can be corrected to =0.6g/L. 8. Serum human immunodeficiency virus(HIV) antigen or antibody negative; Hepatitis C virus (HCV) antibody is negative, or HCV antibody is positive, but HCV RNA is negative;HBV copies less than 1E+03 copies/ml. 9. The left ventricular ejection fraction (LVEF) was normal. 10. No uncontrollable infection. 11. Contraception for both male or female. 12. Informed consent obtained. Exclusion Criteria: 1. Allergic to doxorubicin and/or etoposide and/or PD-1 antibody Injection 2. Severe myocardial injury, myocardial enzymes CK, CK-MB increased more than 3 times ULN (upper limit of normal) 3. Heart function above grade II (NYHA). 4. Thyroid dysfunction 5. Serious mental illness; 6. Active hemorrhage of internal organs 7. Previously received L-DEP regimen for HLH-targeted treatment, but the treatment was ineffective or relapsed 8. Accumulated dose of doxorubicin above 300mg/m2 or epirubicin above 450mg/m2 9. Participate in other clinical research at the same time.

Study Design


Related Conditions & MeSH terms

  • Hemophagocytic Lymphohistiocytosis
  • Lymphohistiocytosis, Hemophagocytic

Intervention

Drug:
L-DEP and PD-1 antibody
Doxorubicin (doxorubicin hydrochloride liposome injection) 25 mg/m2 day 1; etoposide 100 mg/m2 was administered day1; methylprednisolone 2mg/kg days 1 to 3,then 0.25mg/kg day 4 to 14; PD-1 antibody injection 200mg day 5; L-asparaginases 6000iu/m2 day2, day4. This regimen was repeated after 2 weeks.

Locations

Country Name City State
China Beijing Friendship Hospital, Capital Medical University Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary EBV-DNA Outcome of patients with EBV-HLH Change from before and 2,4,6 and 8 weeks after initiating DEP combine with PD-1 antibody therapy
Secondary Survival Outcome of patients with EBV-HLH 3 months after the intervention
Secondary 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
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