MAP-guided Preemptive Therapy of aGvHD by Ruxolitinib
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16-60
SponsorSichuan University
About this trial
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.
Eligibility criteria
Qualifiers
Any donor type (e.g., related, unrelated, haplo) or stem cell source (bone marrow, peripheral blood, cord blood).
Any conditioning regimen (non-myeloablative, myeloablative, or reduced intensity) is acceptable.
GVHD prophylaxis must include a calcineurin inhibitor combined with post transplant cyclophosphamide.
The use of serotherapy to prevent GVHD (e.g., antithymocyte globulin) prior to day 3 post-HCT is permitted
Disqualifiers
Patients who develop acute GVHD prior to start of study drug
Patients at very high risk for relapse post HCT as defined by very high disease risk index
Patients participating in a clinical trial where prevention of GVHD is the primary endpoint
Uncontrolled active infection (i.e., progressive symptoms related to infection despite treatment or persistently positive microbiological cultures despite treatment or any other evidence of severe sepsis)
Trial design
Treatments tested in this trial
- Ruxolitinib
Treatment groups
62 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov