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

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ClinicalTrials.gov Identifier: NCT02631109
Recruitment Status : Recruiting
First Posted : December 16, 2015
Last Update Posted : August 4, 2016
Sponsor:
Information provided by (Responsible Party):
Zhao Wang, Beijing Friendship Hospital

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.

Condition or disease Intervention/treatment Phase
Hemophagocytic Lymphohistiocytosis Drug: Pegaspargase Drug: doxorubicin Drug: etoposide Drug: methylprednisolone Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: L-DEP Regimen as a Salvage Therapy for Refractory Epstein Barr Virus-induced Hemophagocytic Lymphohistiocytosis
Study Start Date : December 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2019


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




Primary Outcome Measures :
  1. 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%.


  2. 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 ]

Secondary Outcome Measures :
  1. Survival [ Time Frame: from the time patients received L-DEP salvage therapy up to 24 months or November 2019 ]
  2. 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.



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Ages Eligible for Study:   14 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02631109


Contacts
Contact: jingshi wang, M.M. 86-13520280731 wangjingshi987@sina.com

Locations
China, Beijing
Beijing Friendship Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: jingshi wang, M.M.    86-13520280731    wangjingshi987@sina.com   
Sponsors and Collaborators
Beijing Friendship Hospital
Investigators
Principal Investigator: zhao wang, M.D. Beijing Friendship Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zhao Wang, Doctor, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT02631109     History of Changes
Other Study ID Numbers: L-DEP-EBV-HLH
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016

Keywords provided by Zhao Wang, Beijing Friendship Hospital:
Pegaspargase
hemophagocytic lymphohistiocytosis
Epstein Barr virus

Additional relevant MeSH terms:
Lymphohistiocytosis, Hemophagocytic
Histiocytosis, Non-Langerhans-Cell
Histiocytosis
Lymphatic Diseases
Doxorubicin
Liposomal doxorubicin
Etoposide
Etoposide phosphate
Pegaspargase
Methylprednisolone Hemisuccinate
Prednisolone
Asparaginase
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents