Clinical Trial: Trial of DA-EPOCH Regimen for NHL With HLH

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Clinical Study of Dose-adjusted EPOCH Regimen for Non-Hodgkin's Lymphoma With Hemophagocytic Lymphohistiocytosis

Brief Summary: The major purpose of this clinical study is to assess clinical outcome of dose-adjusted EPOCH regimen for patients with non-Hodgkin's lymphoma(NHL)-associated hemophagocytic lymphohistiocytosis

Detailed Summary: Lymphoma-associated hemophagocytic lymphohistiocytosis(LA-HLH) has a high fatality rate and the worst outcome. The major cause of LA-HLH is aggressive non-Hodgkin's lymphoma(NHL), especially T/NKT cell lymphomas. Until now, there is no recommended therapeutic schedule for this fatal disease. Dose-adjusted(DA) EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) shows effective activity in patients with aggressive NHL. The investigators therefore developed DA-EPOCH regimen to treat non-Hodgkin's lymphoma with hemophagocytic lymphohistiocytosis and assess its clinical outcome including safety and efficacy.
Sponsor: The First Affiliated Hospital with Nanjing Medical University

Current Primary Outcome:

  • overall response rate [ Time Frame: one year ]
    overall response rate after treated by DA-EPOCH regimen
  • Time to Response [ Time Frame: four weekd after treatment of DA-EPOCH ]
    To determine the median time to overall response


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • progression free survival [ Time Frame: one year ]
    progression free survival after treatment of DA-EPOCH regimen
  • overall survival [ Time Frame: one year ]
    overall survival after treatment of DA-EPOCH regimen
  • Number of Participants with Adverse Events [ Time Frame: up to 30 days after last dose of treatment ]
    Number of Participants with Adverse Events, and evaluated standard is according to common terminology criteria adverse events(CTCAE) version 4.0


Original Secondary Outcome: Same as current

Information By: The First Affiliated Hospital with Nanjing Medical University

Dates:
Date Received: March 23, 2013
Date Started: June 2012
Date Completion: April 2014
Last Updated: March 23, 2013
Last Verified: March 2013