Chidamide Combines With VP-16 and Methylprednisolone in the Treatment of HLH

Hemophagocytic Lymphohistiocytosis Clinical Trial

Official title:

Chidamide Combines With Etoposide and Methylprednisolone in the Treatment of Hemophagocytic Lymphohistiocytosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05137522
• Other study ID #: Chidamide,VP-16,HLH
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: August 2021
• Source: Beijing Friendship Hospital
• Contact: Wang Zhao
• Phone: 86-010-63139862
• Email: wangzhao[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chidamide combines with VP-16 and methylprednisolone in HLH

Description:

This study aimed to investigate the efficacy and safety of Chidamide together with Etoposide and methylprednisolone for hemophagocytic lymphohistiocytosis

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:Meet hemophagocytic lymphohistiocytosis (HLH)-04 diagnostic criteria; patients were diagnosed with EBV associated HLH (EBV-HLH) and lymphoma associated HLH.Age =18 years old, gender is not limited. Serum creatinine = 1.5 times normal;NT-proBNP = normal;Informed consent obtained.

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Exclusion Criteria: Active bleeding of the internal organs or patients with new thrombotic diseases;Allergic to Chidamide and etoposide;Participate in other clinical research at the same time;HIV , HBV and HCV infected patients (HIV antibody positive);History of QT interval prolongation, atrioventricular block, ventricular tachycardia, coronary atherosclerotic heart disease;Pregnant or lactating women and patients of childbearing age who refuse to take appropriate contraceptive measures during this trial. If the patient was male, he refused to use adequate contraceptive methods or donate semen during the study period and within 3 months after receiving the last cycle of drug study;patients judged by the investigator to be unsuitable to participate in this study.

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Related Conditions & MeSH terms

• Chidamide
• Hemophagocytic Lymphohistiocytosis
• Lymphohistiocytosis, Hemophagocytic

Intervention

Drug:
• Chidamide combines with VP-16 and methylprednisolone
Chidamide 30mg TIW po,etoposide 100 mg/m2 was administered day1; methylprednisolone 2mg/kg days 1 to 3,then 0.75mg/kg day 4 to 6,0.25mg/kg day 7 to 9,and 0.1mg/kg day 10 to 21

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	treatment-related adverse events as assessed by CTCAE v5.0	Adverse events including liver function damage, myelosuppression, infection, bleeding	4 weeks after Chidamide combines with VP-16 and methylprednisolone was used
Primary	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, and triglyceride; hemoglobin; neutrophil counts; platelet counts; and alanine aminotransferase (ALT).; 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%; 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%.Overall response rate (ORR) is defined as the ratio of patients with CR and PR to overall patients	4 weeks after Chidamide combines with VP-16 and methylprednisolone was used
Secondary	EBV-DNA copies	EBV-DNA copies in peripheral blood for patients with EBV positive when they enrolled	4 weeks after Chidamide combines with VP-16 and methylprednisolone was used
Secondary	relapsed rate of HLH		4 weeks after Chidamide combines with VP-16 and methylprednisolone was used
Secondary	the response rate of lymphoma	lymphoma associated HLH	4 weeks after Chidamide combines with VP-16 and methylprednisolone was used