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DEP-Ru Regimen as a Salvage Therapy for HLH

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03533790
Recruitment Status : Recruiting
First Posted : May 23, 2018
Last Update Posted : May 30, 2018
Information provided by (Responsible Party):
Zhao Wang, Beijing Friendship Hospital

Brief Summary:
This study aimed to investigate the efficacy and safety of ruxolitinib together with liposomal doxorubicin, etoposide and methylprednisolone (DEP-Ru) as a salvage therapy for refractory/relapsed hemophagocytic lymphohistiocytosis.

Condition or disease Intervention/treatment Phase
Hemophagocytic Lymphohistiocytosis Drug: DEP-Ru Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DEP-ruxolitinib Regimen as a Salvage Therapy for Refractory/Relapsed Hemophagocytic Lymphohistiocytosis
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: DEP-Ru
doxorubicin (doxorubicin hydrochloride liposome injection) 25 mg/m2 day 1; etoposide 100 mg/m2 was administered day1; methylprednisolone 2 mg/kg days 1 to 5,then gradually reduce; ruxolitinib 0.3mg/kg/d。This regimen was repeated after 2 weeks.
Drug: DEP-Ru
  • Drug: ruxolitinib
  • Drug: doxorubicin
  • Drug: etoposide
  • Drug: methylprednisolone

Primary Outcome Measures :
  1. Evaluation of treatment response [ Time Frame: Change from before and 2,4,6 and 8 weeks after initiating DEP-Ru 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%.

Secondary Outcome Measures :
  1. Survival [ Time Frame: from the time patients received DEP-Ru salvage therapy up to 24 months or June 2021 ]

  2. Adverse events that are related to treatment [ Time Frame: through study completion, an average of 2 years ]
    Adverse events including myelosuppression, infection, bleeding and so on.

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. meet HLH-04 diagnostic criteria;
  2. treated with HLH-94 no less than 2 weeks before enrollment and did not achieve at least PR; or relapsed patients after remission;
  3. Life expectancy exceeds 1 month;
  4. Age≥1 year old and ≤70 years old, gender is not limited;
  5. Before the start of the study, total bilirubin ≤ 10 times the upper limit of normal; serum creatinine ≤ 1.5 times normal;
  6. Serum HIV antigen or antibody negative;
  7. HCV antibody is negative, or HCV antibody is positive, but HCV RNA is negative;
  8. Both HBV surface antigen and HBV core antibody were negative. If any of the above is positive, peripheral blood hepatitis B virus DNA titer should be detected, and less than 1×103 copies/ml can enter the group;
  9. Echocardiographic examination of LVEF ≥ 50%;
  10. 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. Serious mental illness;
  8. Non-melanoma skin cancer history;
  9. Patients unable to comply during the trial and/or follow-up phase;
  10. 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 identifier (NCT number): NCT03533790

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Contact: jingshi wang 86-010-63139862

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China, Beijing
Beijing Friendship Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: jingshi wang, M.M.    86-13520280731   
Sponsors and Collaborators
Beijing Friendship Hospital
Publications of Results:
Other Publications:
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Responsible Party: Zhao Wang, Clinical Professor, Beijing Friendship Hospital Identifier: NCT03533790    
Other Study ID Numbers: DEP-Ru HLH
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018

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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
Lymphatic Diseases