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Ruxolitinib as a Salvage Therapy for Hemophagocytic Lymphohistiocytosis

Primary Purpose

Hemophagocytic Lymphohistiocytosis

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
low dose ruxolitinib
high dose ruxolitinib
Sponsored by
Beijing Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemophagocytic Lymphohistiocytosis

Eligibility Criteria

1 Year - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. meet hemophagocytic lymphohistiocytosis (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 ≤75 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 human immunodeficiency virus(HIV) antigen or antibody negative；
  7. Hepatitis C virus (HCV) antibody is negative, or HCV antibody is positive, but HCV RNA is negative；
  8. Both hepatitis B virus (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. Informed consent.

Exclusion Criteria:

  1. Pregnancy or lactating Women；
  2. Allergic to ruxolitinib；
  3. Active bleeding of the internal organs；
  4. uncontrollable infection；
  5. Serious mental illness;
  6. Non-melanoma skin cancer history;
  7. Patients unable to comply during the trial and/or follow-up phase;
  8. Participate in other clinical research at the same time.

Sites / Locations

  • Beijing Friendship Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Low dose

High dose

Arm Description

Outcomes

Primary Outcome Measures

Response rate
complete response (CR) and partial response (PR) rates
Progression Free Survival
from date of inclusion to date of progression, relapse, or death from any cause Overall Survival

Secondary Outcome Measures

Overall Survival
from the date of inclusion to date of death, irrespective of cause Adverse Events
Adverse events
Adverse events including myelosuppression, infection, bleeding and so on.

Full Information

First Posted
October 6, 2019
Last Updated
October 27, 2019
Sponsor
Beijing Friendship Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04120090
Brief Title
Ruxolitinib as a Salvage Therapy for Hemophagocytic Lymphohistiocytosis
Official Title
Clinical Study of Different Doses of Ruxolitinib as a Salvage Therapy for Refractory/Relapsed Hemophagocytic Lymphohistiocytosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
July 1, 2020 (Anticipated)
Study Completion Date
July 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Friendship Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aimed to investigate the efficacy and safety of different doses of ruxolitinib as a salvage therapy for refractory/relapsed hemophagocytic lymphohistiocytosis(HLH).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophagocytic Lymphohistiocytosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low dose
Arm Type
Active Comparator
Arm Title
High dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
low dose ruxolitinib
Intervention Description
The dose for adult patients(Age>=14 years) is generally 10 mg twice daily. For children(Age<14 years ,weight >=25kg),the dose was generally 5mg twice daily. For children(Age<14 years, weight <25kg), the dose was generally 2.5mg twice daily.
Intervention Type
Drug
Intervention Name(s)
high dose ruxolitinib
Intervention Description
The dose for adult patients(Age>=14 years) is generally 20mg twice daily. For children(Age<14 years ,weight >=25kg),the dose was generally 10mg twice daily. For children(Age<14 years, weight <25kg), the dose was generally 5mg twice daily
Primary Outcome Measure Information:
Title
Response rate
Description
complete response (CR) and partial response (PR) rates
Time Frame
1 years
Title
Progression Free Survival
Description
from date of inclusion to date of progression, relapse, or death from any cause Overall Survival
Time Frame
1 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
from the date of inclusion to date of death, irrespective of cause Adverse Events
Time Frame
1 years
Title
Adverse events
Description
Adverse events including myelosuppression, infection, bleeding and so on.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: meet hemophagocytic lymphohistiocytosis (HLH)-04 diagnostic criteria; treated with HLH-94 no less than 2 weeks before enrollment and did not achieve at least PR; or relapsed patients after remission； Life expectancy exceeds 1 month; Age≥1 year old and ≤75 years old, gender is not limited； Before the start of the study, total bilirubin ≤ 10 times the upper limit of normal; serum creatinine ≤ 1.5 times normal； Serum human immunodeficiency virus(HIV) antigen or antibody negative； Hepatitis C virus (HCV) antibody is negative, or HCV antibody is positive, but HCV RNA is negative； Both hepatitis B virus (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； Informed consent. Exclusion Criteria: Pregnancy or lactating Women； Allergic to ruxolitinib； Active bleeding of the internal organs； uncontrollable infection； Serious mental illness; Non-melanoma skin cancer history; Patients unable to comply during the trial and/or follow-up phase; Participate in other clinical research at the same time.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jingshi wang
Phone
86-010-63139862
Email
wangjingshi987@126.com
Facility Information:
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhao wang

12. IPD Sharing Statement

Plan to Share IPD
No

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Ruxolitinib as a Salvage Therapy for Hemophagocytic Lymphohistiocytosis

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