Ruxolitinib as First Line Treatment in Primary Haemophagocytic Lymphohistiocytosis (R-HLH)

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT05762640
Phase
PHASE2
Status
Recruiting
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Conditions

  • Haemophagocytic Lymphohistiocytosis

Eligibility Criteria

Sex
ALL
Age
N/A - 22 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    Form: tablets, 50 mg/m2/day in two administrations. Maximum dose is 100 mg/day. Administration in association with Methylprednisolone IV (or Prednisolone PO) starting at 2 mg/kg/day in two administrations. Duration of treatment: until D-1 of conditioning for allogeneic HSCT OR 9weeks for patients who are not eligible for HSCT.

Study Details

The purpose of this project is to study the survival of patients until Haematopoietic Stem Cell Transplantation following the use of Ruxolitinib as first-line treatment associated to corticosteroids in primary HLH.

Key Dates

Start date
Nov 10, 2024
Status verified
Mar 2026
Primary completion
May 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib

Primary Outcome Measure

Survival until HSCT [ Time Frame: Day 0 until HSCT, up to 8 weeks ]

Central Contacts