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Trial record 8 of 9 for:    Dexamethasone | "familial hemophagocytic lymphohistiocytosis"

L-DEP as an Initial Treatment for EBV-HLH

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ClinicalTrials.gov Identifier: NCT02912702
Recruitment Status : Recruiting
First Posted : September 23, 2016
Last Update Posted : September 23, 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 an initial treatment for Epstein Barr virus-induced hemophagocytic lymphohistiocytosis.

Condition or disease Intervention/treatment Phase
Hemophagocytic Lymphohistiocytosis Drug: Pegaspargase Drug: doxorubicin hydrochloride liposome injection Drug: etoposide Drug: methylprednisolone Drug: Etoposide Drug: dexamethasone Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of L-DEP as an Initial Treatment for Epstein-Barr Virus-associated Hemophagocytic Lymphohistiocytosis
Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2019


Arm Intervention/treatment
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
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

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
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




Primary Outcome Measures :
  1. 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%.



Secondary Outcome Measures :
  1. 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 ]
  2. 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.

  3. 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 ]


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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 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

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): NCT02912702


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

Locations
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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

Publications:
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Responsible Party: Zhao Wang, Doctor, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT02912702     History of Changes
Other Study ID Numbers: L-DEP-EBV-HLH-First line
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
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Dexamethasone
Dexamethasone acetate
BB 1101
Lymphohistiocytosis, Hemophagocytic
Histiocytosis, Non-Langerhans-Cell
Histiocytosis
Lymphatic Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Doxorubicin
Liposomal doxorubicin
Etoposide
Etoposide phosphate
Pegaspargase
Asparaginase
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal