DEP-Ru Regimen as a Salvage Therapy for HLH

May 26, 2018 updated by: Zhao Wang, Beijing Friendship Hospital

DEP-ruxolitinib Regimen as a Salvage Therapy for Refractory/Relapsed Hemophagocytic Lymphohistiocytosis

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.

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Friendship Hospital, Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: ruxolitinib
  • Drug: doxorubicin
  • Drug: etoposide
  • Drug: methylprednisolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
Change from before and 2,4,6 and 8 weeks after initiating DEP-Ru salvage therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: from the time patients received DEP-Ru salvage therapy up to 24 months or June 2021
survival
from the time patients received DEP-Ru salvage therapy up to 24 months or June 2021
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.
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2018

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

May 12, 2018

First Submitted That Met QC Criteria

May 12, 2018

First Posted (Actual)

May 23, 2018

Study Record Updates

Last Update Posted (Actual)

May 30, 2018

Last Update Submitted That Met QC Criteria

May 26, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • DEP-Ru HLH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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