MAP-guided Preemptive Therapy of aGvHD by Ruxolitinib

Phase 2Not Yet RecruitingNCT06075225

Sichuan University62 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

GVHD Acute Stem Cell Transplant Complications

Interventions

Eligibility

Sex: ALLMin age: 16 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 * Direct bilirubin must be \<2 mg/dL unless the elevation is known to be due to Gilbert syndrome within 3 days prior to enrollment. * ALT/SGPT and AST/SGOT must be \<5 x the upper limit of the normal range within 3 days prior to enrollment. * Signed and dated written informed consent obtained from patient or legal representative. Exclusion Criteria: * 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) * Patients who are pregnant * Patients on dialysis within 7 days of enrollment * Patients requiring ventilator support or oxygen supplementation exceeding 40% FiO2 within 14 days of enrollment. * Patients receiving investigational agent within 30 days of enrollment. However, the Principal Investigator (PI) may approve prior use of an investigational agent if the agent is not expected to interfere with the safety or the efficacy of ruxolitinib

Outcomes

Primary Outcomes

Number of High Risk Patients Who Develop Grade III or IV aGvHD

Number of High Risk Patients Who Develop Grade III or IV aGvHD by day 100 post HCT

Time frame: Day 100 post HCT

Secondary Outcomes

Number of Participants With Non-relapse Mortality (NRM)

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: 6 months

Number of Participants With Chronic GVHD Requiring Systemic Steroid Treatment

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