Hemophagocytic Lymphohistiocytosis
Conditions
Brief summary
his study aimed to investigate the efficacy of etoposide as the first line therapy for adult Epstein-Barr virus-associated hemophagocytic lymphohistiocytosis.
Interventions
DRUGEtoposide
150 mg/m2 twice weekly for 2 weeks and then weekly
DRUGDexamethasone
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
DRUGIVIG
0.5 g/kg, once every 4 weeks
Sponsors
Beijing Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response(complete response+ partial response) rate of Participants | Change from before and 2,4 weeks after initiating thearpy | 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%. |
Secondary
| Measure | Time frame |
|---|---|
| Compare survival between two arms | from the time patients received therapy up to 12 months or December 2020 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | through study completion, an average of 1 years | Adverse events including pancreatitis, liver function damage, myelosuppression, infection, bleeding and so on. |
Countries
China
Outcome results
None listed