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

Not Applicable

• Conditions: Chidamide; Hemophagocytic Lymphohistiocytosis
• Interventions: Drug: Chidamide combines with VP-16 and methylprednisolone

• Registration Number: NCT05137522
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

Chidamide combines with VP-16 and methylprednisolone in HLH

Detailed Description

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

Study Timeline

• Study Start: 2021-07-01
• Status Verified: 2021-08
• Study First Submitted: 2021-11-24
• Study First Submitted QC: 2021-11-29
• Last Update Submitted: 2021-11-29
• Study First Posted: 2021-11-30
• Last Update Posted: 2021-11-30
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Assigned Interventions	Chidamide combines with VP-16 and methylprednisolone	Chidamide combines with VP-16 and methylprednisolone

Primary Outcome Measures

Name	Time	Method
Evaluation of treatment response	4 weeks after Chidamide combines with VP-16 and methylprednisolone was used	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

Secondary Outcome Measures

Name	Time	Method
the response rate of lymphoma	4 weeks after Chidamide combines with VP-16 and methylprednisolone was used	lymphoma associated HLH
EBV-DNA copies	4 weeks after Chidamide combines with VP-16 and methylprednisolone was used	EBV-DNA copies in peripheral blood for patients with EBV positive when they enrolled
relapsed rate of HLH	4 weeks after Chidamide combines with VP-16 and methylprednisolone was used

Trial Locations

Locations (1)

Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, China