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

NCT05137522 | Unknown DMC

• 1 other identifier: Chidamide,VP-16,HLH
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Chidamide combines with VP-16 and methylprednisolone in HLH

Conditions

Chidamide; Hemophagocytic Lymphohistiocytosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• EBV-DNA copies

  4 weeks after Chidamide combines with VP-16 and methylprednisolone was used

• relapsed rate of HLH

  4 weeks after Chidamide combines with VP-16 and methylprednisolone was used

• the response rate of lymphoma

  4 weeks after Chidamide combines with VP-16 and methylprednisolone was used

Other Outcomes (1)

• treatment-related adverse events as assessed by CTCAE v5.0

  4 weeks after Chidamide combines with VP-16 and methylprednisolone was used

Study Arms (1)

Assigned Interventions

EXPERIMENTAL

Chidamide combines with VP-16 and methylprednisolone

Drug: Chidamide combines with VP-16 and methylprednisolone

Interventions

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

Assigned Interventions

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Lymphohistiocytosis, Hemophagocytic

Interventions

Etoposide; Methylprednisolone

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Wang Zhao

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Zhao

CONTACT

86-010-63139862; wangzhao@ccmu.edu.cn

Yahong You

CONTACT

17810283962; 15332022659@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: November 30, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: November 30, 2021

Record last verified: 2021-08

Locations

CN (1)