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Trial record 5 of 8 for:    "Non-Langerhans-Cell Histiocytosis" | "Antibiotics, Antitubercular"

L-DEP as an Initial Treatment for EBV-HLH

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ClinicalTrials.gov Identifier: NCT02912702
Recruitment Status : Unknown
Verified September 2016 by Zhao Wang, Beijing Friendship Hospital.
Recruitment status was:  Recruiting
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Zhao Wang, Beijing Friendship Hospital

Tracking Information
First Submitted Date  ICMJE September 9, 2016
First Posted Date  ICMJE September 23, 2016
Last Update Posted Date September 23, 2016
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2016)
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 Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2016)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE L-DEP as an Initial Treatment for EBV-HLH
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hemophagocytic Lymphohistiocytosis
Intervention  ICMJE
  • Drug: Pegaspargase
    2000U/m2 day5
  • Drug: doxorubicin hydrochloride liposome injection
    25 mg/m2 day 1
  • 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
  • Drug: Etoposide
    150 mg/m2 twice weekly for 2 weeks and then weekly
  • Drug: dexamethasone
    initially 10 mg/m2 for 2 weeks followed by 5 mg/m2 for 2 weeks, 2.5 mg/m2 for 2 weeks, 1.25 mg/m2 for one week, and one week of tapering
Study Arms  ICMJE
  • Experimental: L-DEP
    Pegaspargase 2000U/m2 day5; 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
    Interventions:
    • Drug: Pegaspargase
    • Drug: doxorubicin hydrochloride liposome injection
    • Drug: etoposide
    • Drug: methylprednisolone
  • Active Comparator: HLH-94 regimen
    Etoposide 150 mg/m2 twice weekly for 2 weeks and then weekly; dexamethasone initially 10 mg/m2 for 2 weeks followed by 5 mg/m2 for 2 weeks, 2.5 mg/m2 for 2 weeks, 1.25 mg/m2 for one week, and one week of tapering
    Interventions:
    • Drug: Etoposide
    • Drug: dexamethasone
Publications * Wang Y, Huang W, Hu L, Cen X, Li L, Wang J, Shen J, Wei N, Wang Z. Multicenter study of combination DEP regimen as a salvage therapy for adult refractory hemophagocytic lymphohistiocytosis. Blood. 2015 Nov 5;126(19):2186-92. doi: 10.1182/blood-2015-05-644914. Epub 2015 Aug 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 21, 2016)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients were older than 14 years of age
  2. Diagnosed as EBV-Hemophagocytic Lymphohistiocytosis (HLH)
  3. Patients did not receive any treatment for HLH before
  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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02912702
Other Study ID Numbers  ICMJE L-DEP-EBV-HLH-First line
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Zhao Wang, Beijing Friendship Hospital
Study Sponsor  ICMJE Beijing Friendship Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Beijing Friendship Hospital
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP