Ruxolitinib as a Salvage Therapy for Hemophagocytic Lymphohistiocytosis

NCT ID: NCT04120090

Last Updated: 2019-10-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2020-07-01

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).

Conditions

Hemophagocytic Lymphohistiocytosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low dose

Group Type: ACTIVE_COMPARATOR

low dose ruxolitinib

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

high dose ruxolitinib

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Wang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

jingshi wang

Role: CONTACT

wangjingshi987@126.com

86-010-63139862

Facility Contacts

zhao wang

Role: primary

Other Identifiers

Ruxolitinib-HLH

Identifier Type: -

Identifier Source: org_study_id