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

August 3, 2016 updated by: Zhao Wang, Beijing Friendship Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Friendship Hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients were older than 14 years of age
  2. Diagnosed as EBV-Hemophagocytic Lymphohistiocytosis (HLH)
  3. Patients did not achieve at lease partial response after initial treatment including HLH-94 or DEP no less than 2 weeks
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: L-DEP
Pegaspargase 2000U/m2 day5; doxorubicin (doxorubicin hydrochloride liposome injection) 25 mg/m2 day 1; etoposide 100 mg/m2 was administered once on the first day of every week; methylprednisolone 15 mg/kg days 1 to 3, 0.75 mg/kg days 4 to 7
Drug: Pegaspargase
2000U/m2 day5
Drug: doxorubicin
25mg/m2 day1
Drug: etoposide
100 mg/m2 was administered once on the first day of every week
Drug: methylprednisolone
15 mg/kg days 1 to 3, 0.75 mg/kg days 4 to 7

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 from before and 2,4,6 and 8 weeks after initiating L-DEP salvage therapy
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
Change from before and 2, 4, 6 and 8 weeks after initiating L-DEP salvage therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: from the time patients received L-DEP salvage therapy up to 24 months or November 2019
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.
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Friendship Hospital

Investigators

  • Principal Investigator: zhao wang, M.D., Beijing Friendship Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

December 3, 2015

First Submitted That Met QC Criteria

December 11, 2015

First Posted (Estimate)

December 16, 2015

Study Record Updates

Last Update Posted (Estimate)

August 4, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L-DEP-EBV-HLH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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