Ruxolitinib as a Salvage Therapy for Hemophagocytic Lymphohistiocytosis

Hemophagocytic Lymphohistiocytosis Clinical Trial

Official title:

Clinical Study of Different Doses of Ruxolitinib as a Salvage Therapy for Refractory/Relapsed Hemophagocytic Lymphohistiocytosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04120090
• Other study ID #: Ruxolitinib-HLH
• Status: Recruiting
• Phase: Phase 3
• Start date: July 1, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: October 2019
• Source: Beijing Friendship Hospital
• Contact: jingshi wang
• Phone: 86-010-63139862
• Email: wangjingshi987[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemophagocytic Lymphohistiocytosis
• Lymphohistiocytosis, Hemophagocytic

Intervention

Drug:
• low 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.
• high 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

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	complete response (CR) and partial response (PR) rates	1 years
Primary	Progression Free Survival	from date of inclusion to date of progression, relapse, or death from any cause Overall Survival	1 years
Secondary	Overall Survival	from the date of inclusion to date of death, irrespective of cause Adverse Events	1 years
Secondary	Adverse events	Adverse events including myelosuppression, infection, bleeding and so on.	1 year