Clinical Trial: L-DEP Regimen as a Salvage Therapy for Refractory Epstein Barr Virus-induced Hemophagocytic Lymphohistiocytosis

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

Official Title: L-DEP Regimen as a Salvage Therapy for Refractory Epstein Barr Virus-induced 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 a salvage therapy for refractory Epstein Barr virus-induced hemophagocytic lymphohistiocytosis.

Detailed Summary:
Sponsor: Beijing Friendship Hospital

Current Primary Outcome:

  • Evaluation of treatment response [ Time Frame: Change from before and 2,4,6 and 8 weeks after initiating L-DEP salvage therapy ]

    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%.

  • Change of Epstein-Barr virus(EBV)-DNA [ Time Frame: Change from before and 2, 4, 6 and 8 weeks after initiating L-DEP salvage therapy ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Survival [ Time Frame: from the time patients received L-DEP salvage therapy up to 24 months or November 2019 ]
  • Adverse events that are related to treatment [ Time Frame: through study completion, an average of 2 years ]
    Adverse events including pancreatitis, liver function damage, myelosuppression, infection, bleeding and so on.


Original Secondary Outcome: Same as current

Information By: Beijing Friendship Hospital

Dates:
Date Received: December 3, 2015
Date Started: December 2015
Date Completion: November 2019
Last Updated: August 3, 2016
Last Verified: August 2016