West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
NCT Number: NCT06075225
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.
Trial opening soon.
Get Notified16 year–60 year
All sexes
Interventional
Phase 2
Chengdu, Sichuan, 610041, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Day 100 post HCT
Number of High Risk Patients Who Develop Grade III or IV aGvHD by day 100 post HCT
Time frame: 6 months
Number of participants with NRM - deaths which could not be attributed to disease relapse or progression. Nonrelapse mortality defined as death without prior relapse at 6 months
Time frame: 1 year and 2 years
Number of participants with chronic GVHD requiring systemic steroid treatment. Chronic GVHD Requiring Systemic Steroid Treatment: defined as the development of symptoms of chronic GVHD according to NIH Consensus Criteria that require treatment with oral or intravenous corticosteroids at the end of 1 year and 2 years
Time frame: 1 year and 2 years
Survival of patients without grade 3 or 4 aGvHD or disseminated cGvHD or relapse of disease at end of 1 year post HCT at the end of 1 year and 2 years
Time frame: 1 year and 2 years
Progression-free survival of this group of patients at the end of 1 year and 2 years
Time frame: 1 year and 2 years
Overall survival of this group of patients at the end of 1 year and 2 years
Time frame: 1 year and 2 years
Number of participants with relapse at one year and 2 years. Relapse defined as recurrence of disease that required transplant.
Time frame: 1 year and 2 years
Number of participants with serious infections (defined as grade 3 by the Blood and Marrow Transplant Clinical Trials Network). Serious Infection: Defined as bacterial, fungal, viral or parasitic infections that required oral or intravenous treatments such as antibiotics
Time frame: 1 year and 2 years
Number of participants with cytomegalovirus (CMV) reactivation at the end of 1 year and 2 years. CMV reactivation was defined as the presence of DNA copies exceeding 10^3/ml in plasma.
Time frame: 1 year and 2 years
Number of participants with grade 2 or higher hemorrhagic cystitis at the end of 1 year and 2 years, which was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Time frame: Day 28 post HCT
The change in the patient's MAGIC algorithm probability (MAP) at each time
Contact information is provided by the study sponsor or research team.
Sichuan University
Other
The MAGIC Algorithm Probability Guided Preemption of Steroid-refractory Graft-versus-host Disease With Ruxolitinib
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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