Back to resultsChidamide Combines With VP-16 and Methylprednisolone in the Treatment of HLH
Primary Purpose
Chidamide, Hemophagocytic Lymphohistiocytosis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Chidamide combines with VP-16 and methylprednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Chidamide
Eligibility 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.
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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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Sites / Locations
- Beijing Friendship HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Assigned Interventions
Arm Description
Chidamide combines with VP-16 and methylprednisolone
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
EBV-DNA copies
EBV-DNA copies in peripheral blood for patients with EBV positive when they enrolled
relapsed rate of HLH
the response rate of lymphoma
lymphoma associated HLH
Full Information
NCT ID
NCT05137522
First Posted
November 24, 2021
Last Updated
November 29, 2021
Sponsor
Beijing Friendship Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05137522
Brief Title
Chidamide Combines With VP-16 and Methylprednisolone in the Treatment of HLH
Official Title
Chidamide Combines With Etoposide and Methylprednisolone in the Treatment of Hemophagocytic Lymphohistiocytosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Friendship Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chidamide, Hemophagocytic Lymphohistiocytosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Assigned Interventions
Arm Type
Experimental
Arm Description
Chidamide combines with VP-16 and methylprednisolone
Intervention Type
Drug
Intervention Name(s)
Chidamide combines with VP-16 and methylprednisolone
Intervention Description
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
Primary Outcome Measure Information:
Title
Evaluation of treatment response
Description
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
Time Frame
4 weeks after Chidamide combines with VP-16 and methylprednisolone was used
Secondary Outcome Measure Information:
Title
EBV-DNA copies
Description
EBV-DNA copies in peripheral blood for patients with EBV positive when they enrolled
Time Frame
4 weeks after Chidamide combines with VP-16 and methylprednisolone was used
Title
relapsed rate of HLH
Time Frame
4 weeks after Chidamide combines with VP-16 and methylprednisolone was used
Title
the response rate of lymphoma
Description
lymphoma associated HLH
Time Frame
4 weeks after Chidamide combines with VP-16 and methylprednisolone was used
Other Pre-specified Outcome Measures:
Title
treatment-related adverse events as assessed by CTCAE v5.0
Description
Adverse events including liver function damage, myelosuppression, infection, bleeding
Time Frame
4 weeks after Chidamide combines with VP-16 and methylprednisolone was used
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
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Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Zhao
Phone
86-010-63139862
Email
wangzhao@ccmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yahong You
Phone
17810283962
Email
15332022659@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang Zhao
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhao wang
12. IPD Sharing Statement
Learn more about this trial
Chidamide Combines With VP-16 and Methylprednisolone in the Treatment of HLH
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