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Chidamide combines with VP-16 and methylprednisolone in HLH
This study aimed to investigate the efficacy and safety of Chidamide together with Etoposide and methylprednisolone for hemophagocytic lymphohistiocytosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assigned Interventions | Experimental | Chidamide combines with VP-16 and methylprednisolone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide combines with VP-16 and methylprednisolone | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| relapsed rate of HLH |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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 diseasesï¼›Allergic to Chidamide and etoposideï¼›Participate in other clinical research at the same timeï¼›HIV , HBV and HCV infected patients (HIV antibody positive)ï¼›History of QT interval prolongation, atrioventricular block, ventricular tachycardia, coronary atherosclerotic heart diseaseï¼›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 studyï¼›patients judged by the investigator to be unsuitable to participate in this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Zhao | Contact | 86-010-63139862 | wangzhao@ccmu.edu.cn | |
| Yahong You | Contact | 17810283962 | 15332022659@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wang Zhao | Beijing Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100050 | China |
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| ID | Term |
|---|---|
| D051359 | Lymphohistiocytosis, Hemophagocytic |
| ID | Term |
|---|---|
| D015616 | Histiocytosis, Non-Langerhans-Cell |
| D015614 | Histiocytosis |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D005047 | Etoposide |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| 4 weeks after Chidamide combines with VP-16 and methylprednisolone was used |
| the response rate of lymphoma | lymphoma associated HLH | 4 weeks after Chidamide combines with VP-16 and methylprednisolone was used |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |