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

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Capital Medical University

Status

Unknown

Conditions

Hemophagocytic Lymphohistiocytosis
Chidamide

Treatments

Drug: Chidamide combines with VP-16 and methylprednisolone

Study type

Interventional

Funder types

Other

Identifiers

NCT05137522
Chidamide,VP-16,HLH

Details and patient eligibility

About

Chidamide combines with VP-16 and methylprednisolone in HLH

Full description

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

Enrollment

20 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Assigned Interventions
Experimental group
Description:
Chidamide combines with VP-16 and methylprednisolone
Treatment:
Drug: Chidamide combines with VP-16 and methylprednisolone

Trial contacts and locations

1

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Central trial contact

Yahong You; Wang Zhao

Data sourced from clinicaltrials.gov

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