Ruxolitinib as a Salvage Therapy for Hemophagocytic Lymphohistiocytosis

Sponsor
Beijing Friendship Hospital
Study ID
NCT04120090
Phase
PHASE3
Status
Unknown

Conditions

  • Hemophagocytic Lymphohistiocytosis

Eligibility Criteria

Sex
ALL
Age
1 Year - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • low dose ruxolitinib — 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 ruxolitinib — 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

Study Details

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

Key Dates

Start date
Jul 1, 2019
Status verified
Oct 2019
Primary completion
Jul 1, 2020
Completion
Jul 1, 2020

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Low dose
  • Experimental: High dose

Primary Outcome Measure

Response rate [ Time Frame: 1 years ]

Central Contacts

Related Studies