Etoposide in the First-line Treatment of Adult EBV-HLH

Hemophagocytic Lymphohistiocytosis Clinical Trial

Official title:

A Randomized Controlled Trial of Etoposide in the First-line Treatment of Adult Epstein-barr Virus Associated Hemophagocytic Lymphohistiocytosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03742115
• Other study ID #: VP-16-adult EBV-HLH-first line
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 1, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: November 2018
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

his study aimed to investigate the efficacy of etoposide as the first line therapy for adult Epstein-Barr virus-associated hemophagocytic lymphohistiocytosis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients were older than 18 years of age

2. Diagnosed as EBV-Hemophagocytic Lymphohistiocytosis (HLH)

3. Patients did not receive any treatment for HLH before

4. Informed consent

Exclusion Criteria:

1. Heart function above grade II (NYHA)

2. Accumulated dose of doxorubicin above 300mg/m2 or epirubicin above 450mg/m2

3. Pregnancy or lactating Women

4. Allergic to Pegaspargase, doxorubicin or etoposide

5. Active bleeding of the internal organs

6. uncontrollable infection

7. history of acute and chronic pancreatitis

8. Participate in other clinical research at the same time

Related Conditions & MeSH terms

• Hemophagocytic Lymphohistiocytosis
• Lymphohistiocytosis, Hemophagocytic

Intervention

Drug:
• Etoposide
150 mg/m2 twice weekly for 2 weeks and then weekly
• Dexamethasone
initially 10 mg/m2 for 2 weeks followed by 5 mg/m2 for 2 weeks, 2.5 mg/m2 for 2 weeks, 1.25 mg/m2 for one week, and one week of tapering
• Etoposide
150 mg/m2 weekly
• IVIG
0.5 g/kg, once every 4 weeks

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Henter JI, Samuelsson-Horne A, Aricò M, Egeler RM, Elinder G, Filipovich AH, Gadner H, Imashuku S, Komp D, Ladisch S, Webb D, Janka G; Histocyte Society. Treatment of hemophagocytic lymphohistiocytosis with HLH-94 immunochemotherapy and bone marrow transplantation. Blood. 2002 Oct 1;100(7):2367-73. — View Citation

Imashuku S, Kuriyama K, Sakai R, Nakao Y, Masuda S, Yasuda N, Kawano F, Yakushijin K, Miyagawa A, Nakao T, Teramura T, Tabata Y, Morimoto A, Hibi S. Treatment of Epstein-Barr virus-associated hemophagocytic lymphohistiocytosis (EBV-HLH) in young adults: a report from the HLH study center. Med Pediatr Oncol. 2003 Aug;41(2):103-9. — View Citation

Imashuku S, Kuriyama K, Teramura T, Ishii E, Kinugawa N, Kato M, Sako M, Hibi S. Requirement for etoposide in the treatment of Epstein-Barr virus-associated hemophagocytic lymphohistiocytosis. J Clin Oncol. 2001 May 15;19(10):2665-73. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Adverse events including pancreatitis, liver function damage, myelosuppression, infection, bleeding and so on.	through study completion, an average of 1 years
Primary	Overall response(complete response+ partial response) rate of Participants	A complete response was defined as normalization of all of the quantifiable symptoms and laboratory markers of HLH, including levels of sCD25(pg/ml), ferritin(µg/L), and triglyceride(mmol/L); hemoglobin(g/L); neutrophil counts(×109/L); platelet counts(×109/L); and alanine aminotransferase (ALT(U/L)).; A partial response was defined as at least a 25% improvement in 2 or more quantifiable symptoms and laboratory markers as follows: sCD25(pg/ml) response was>1.5-fold decreased; ferritin (µg/L)and triglyceride(mmol/L) 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 (U/L)decrease of at least 50%.	Change from before and 2,4 weeks after initiating thearpy
Secondary	Compare survival between two arms		from the time patients received therapy up to 12 months or December 2020