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Status unknownNCT04120090Updated Oct 29, 2019

Ruxolitinib as a Salvage Therapy for Hemophagocytic Lymphohistiocytosis

A Phase 3 interventional study of low dose ruxolitinib and high dose ruxolitinib in Hemophagocytic Lymphohistiocytosis, sponsored by Beijing Friendship Hospital. Status unknown at 1 site in China. Open to participants aged 1 Year to 75 Years. Per ClinicalTrials.gov, last updated 2019-10-29.

Sponsored by Beijing Friendship Hospital · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jul 2019, registered Oct 2019).
Phase
Phase 3
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
1 Year to 75 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Hemophagocytic Lymphohistiocytosis
03

In context

Lymphohistiocytosis, Hemophagocytic

99 studies on the registry are indexed under Lymphohistiocytosis, Hemophagocytic; 36 are open to participants now.

This study's planned enrollment of 80 is above the median of 30 across 68 interventional studies indexed under Lymphohistiocytosis, Hemophagocytic.

Browse Lymphohistiocytosis, Hemophagocytic studies →

Lead sponsor

Beijing Friendship Hospital is the lead sponsor of 216 studies on the registry; 95 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    Low dose

    Drug: low dose ruxolitinib

  • Experimental
    High dose

    Drug: high dose ruxolitinib

Interventions

  • Druglow dose ruxolitinib

    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.

  • Drughigh dose ruxolitinib

    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

06

What researchers measure

Primary outcomes

  1. Response rate

    complete response (CR) and partial response (PR) rates

    Time frame: 1 years

  2. Progression Free Survival

    from date of inclusion to date of progression, relapse, or death from any cause Overall Survival

    Time frame: 1 years

Secondary outcomes

  1. Overall Survival

    from the date of inclusion to date of death, irrespective of cause Adverse Events

    Time frame: 1 years

  2. Adverse events

    Adverse events including myelosuppression, infection, bleeding and so on.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Beijing Friendship Hospital, Capital Medical University
    Beijing, Beijing 100050, China
    • zhao wang · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04120090
Lead sponsor
Beijing Friendship Hospital
Responsible party
Zhao Wang (Clinical Professor, Beijing Friendship Hospital) — Principal investigator
First posted
Oct 9, 2019
Start date
Jul 1, 2019
Primary completion
Jul 1, 2020 (estimated)
Completion
Jul 1, 2020 (estimated)
Last update
Oct 29, 2019

Study contacts

jingshi wang
Contact
wangjingshi987@126.com
86-010-63139862

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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