NCT03795909

Brief Summary

A protocol named as "HLH-DR" for patients with refractory and secondary hemophagocytic lymphohistiocytosismay.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2017

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 8, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

January 8, 2019

Status Verified

January 1, 2019

Enrollment Period

3 years

First QC Date

January 3, 2019

Last Update Submit

January 5, 2019

Conditions

Hemophagocytic Lymphohistiocytosis

Outcome Measures

Primary Outcomes (1)

  • Severity of disease

    Serum ferritin\>2000ng/ml, disease actvie; serum ferritin\<2000ng/ml, disease control;

    2 weeks

Secondary Outcomes (1)

  • Axillary temperature

    2 weeks

Study Arms (2)

Ruxolitinib and Placebo

EXPERIMENTAL

Ruxolitinib 2.5 mg twice daily by oral

Drug: RuxolitinibDrug: Dexamethasone

Placebo and Ruxolitinib

PLACEBO COMPARATOR

Sugar pill 2.5 mg twice daily by oral

Drug: RuxolitinibDrug: Dexamethasone

Interventions

RuxolitinibDRUG

Ruxolitinib （2.5 mg twice daily for patients if the age\<14 years and the weight \<25kg，5 mg twice daily for patients if the age\<14 years and the weight≥25kg, 10mg twice daily for patients if the age ≥14 years and\<18 years）

Also known as: Jakafi
Placebo and RuxolitinibRuxolitinib and Placebo
DexamethasoneDRUG

Dexamethasone (10mg/m2.d) delayes for the first 2 weeks（form week 1 to 2),(5mg/m2.d) from week 3 to 4，(2.5mg/m2.d) from week 5 to 6），1.25mg/m2.d for week 7，and dropped off on week 8.

Also known as: Hormone
Placebo and RuxolitinibRuxolitinib and Placebo

Eligibility Criteria

Age1 Year - 18 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Secondary and refractory HLH.

You may not qualify if:

  • Family HLH.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yan Yue

Beijing, Chaoyang District, 100020, China

RECRUITING

Yan Yue

Beijing, China

RECRUITING

MeSH Terms

Conditions

Lymphohistiocytosis, Hemophagocytic

Interventions

ruxolitinibDexamethasoneHormones

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-CellHistiocytosisLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Yan Yue, MD

    Capital Institute of Pediatrics, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Yue, MD

CONTACT

8618515238169adaile123@sina.com

xiaodong d Shi, MD

CONTACT

861391160107618611196921@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 3, 2019

First Posted

January 8, 2019

Study Start

March 1, 2017

Primary Completion

March 1, 2020

Study Completion

March 1, 2022

Last Updated

January 8, 2019

Record last verified: 2019-01

Locations

CN(2)