MAP-guided Preemptive Therapy of aGvHD by Ruxolitinib

Sponsor
Sichuan University
Study ID
NCT06075225
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Acute Stem Cell Transplant Complications
  • GVHD

Eligibility Criteria

Sex
ALL
Age
16 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    Ruxolitinib is asministrated with the dose of 5mg bid for 28 days. If no signs of aGvHD, the dose of ruxolitinib is gradually tapered within the following 16 days.

Study Details

The goal of this observation study is to test in patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is: • Effect of MAGIC algorithm probability guided preemption of aGVHD with ruxolitinib on prevention of severe aGVHD. Participants will take ruxolitinib with the dose of 5mg bid for 28 days. If no signs of aGvHD, the dose of ruxolitinib is gradually tapered within the following 16 days. Researchers will compare patients who don't receive preemption of aGVHD with ruxolitinib to see if there is an improvement in severe aGVHD.

Key Dates

Start date
Oct 1, 2023
Status verified
Oct 2023
Primary completion
Sep 30, 2024
Completion
Sep 30, 2026

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Ruxolitinib
    Ruxolitinib is asministrated with the dose of 5mg bid for 28 days. If no signs of aGvHD, the dose of ruxolitinib is gradually tapered within the following 16 days.
  • No Intervention: Control
    Patients assigned to the control group are treated based on symptom-triggered aGvHD therapy.

Primary Outcome Measure

Number of High Risk Patients Who Develop Grade III or IV aGvHD [ Time Frame: Day 100 post HCT ]

Central Contacts

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