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Trial record 3 of 14 for:    mg/m2 | "familial hemophagocytic lymphohistiocytosis"

Etoposide in the First-line Treatment of Adult EBV-HLH

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ClinicalTrials.gov Identifier: NCT03742115
Recruitment Status : Not yet recruiting
First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Zhao Wang, Beijing Friendship Hospital

Brief Summary:
his study aimed to investigate the efficacy of etoposide as the first line therapy for adult Epstein-Barr virus-associated hemophagocytic lymphohistiocytosis.

Condition or disease Intervention/treatment Phase
Hemophagocytic Lymphohistiocytosis Drug: Etoposide Drug: Dexamethasone Drug: IVIG Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Etoposide in the First-line Treatment of Adult Epstein-barr Virus Associated Hemophagocytic Lymphohistiocytosis
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2020


Arm Intervention/treatment
Experimental: Etoposide standard group
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

Experimental: Etoposide reduction group
Etoposide 150 mg/m2 once a week; 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: 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 weekly

Active Comparator: Corticosteroid group
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, with or without IvIG (0.5 g/kg IV, once every 4 weeks)
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

Drug: IVIG
0.5 g/kg, once every 4 weeks




Primary Outcome Measures :
  1. Overall response(complete response+ partial response) rate of Participants [ Time Frame: Change from before and 2,4 weeks after initiating thearpy ]

    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 therapy up to 12 months or December 2020 ]

Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients were older than 18 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): NCT03742115


Locations
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China, Beijing
Beijing Friendship Hospital, Capital Medical University Not yet recruiting
Beijing, Beijing, China, 100050
Contact: Yue Song, M.M.    86-18810253070 ext +8601063139862    xueqifeng1992@163.com   
Sponsors and Collaborators
Beijing Friendship Hospital

Publications:
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Responsible Party: Zhao Wang, Dr., Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT03742115     History of Changes
Other Study ID Numbers: VP-16-adult EBV-HLH-first line
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lymphohistiocytosis, Hemophagocytic
Histiocytosis, Non-Langerhans-Cell
Histiocytosis
Lymphatic Diseases
Dexamethasone
Dexamethasone acetate
Etoposide
Etoposide phosphate
BB 1101
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
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors