Clinical Trial: L-DEP as an Initial Treatment for EBV-HLH

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized Controlled Trial of L-DEP as an Initial Treatment for Epstein-Barr Virus-associated Hemophagocytic Lymphohistiocytosis

Brief Summary: This study aimed to investigate the efficacy and safety of Pegaspargase together with liposomal doxorubicin, etoposide and high dose methylprednisolone (L-DEP) as an initial treatment for Epstein Barr virus-induced hemophagocytic lymphohistiocytosis.

Detailed Summary:
Sponsor: Beijing Friendship Hospital

Current Primary Outcome: Overall response(complete response+ partial response) rate of Participants [ Time Frame: Change from before and 2,4,6 and 8 weeks after initiating L-DEP or HLH-94 therapy ]

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%.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Compare survival between two arms [ Time Frame: from the time patients received L-DEP or HLH-94 therapy up to 12 months or September 2019 ]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: through study completion, an average of 1 years ]
    Adverse events including pancreatitis, liver function damage, myelosuppression, infection, bleeding and so on.
  • Change of Epstein-Barr virus(EBV)-DNA before and after therapy [ Time Frame: Change from before and 2, 4, 6 and 8 weeks after initiating L-DEP or HLH-94 therapy ]


Original Secondary Outcome: Same as current

Information By: Beijing Friendship Hospital

Dates:
Date Received: September 9, 2016
Date Started: September 2016
Date Completion: September 2019
Last Updated: September 21, 2016
Last Verified: September 2016