Chidamide, Hemophagocytic Lymphohistiocytosis
Conditions
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
Interventions
DRUGChidamide 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
Sponsors
Beijing Friendship Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| treatment-related adverse events as assessed by CTCAE v5.0 | 4 weeks after Chidamide combines with VP-16 and methylprednisolone was used | Adverse events including liver function damage, myelosuppression, infection, bleeding |
Countries
China
Contacts
Primary ContactWang Zhao
Backup ContactYahong You
Outcome results
None listed