NCT06075225Not yet recruitingPhase 2
The MAGIC Algorithm Probability Guided Preemption of Steroid-refractory Graft-versus-host Disease With Ruxolitinib
Sichuan University1 site in 1 country62 target enrollmentStarted: October 1, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Number of High Risk Patients Who Develop Grade III or IV aGvHD
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Ruxolitinib
Experimental
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.
Intervention: Ruxolitinib (Drug)
Outcomes
Primary Outcomes
Number of High Risk Patients Who Develop Grade III or IV aGvHD
Time Frame: Day 100 post HCT
Number of High Risk Patients Who Develop Grade III or IV aGvHD by day 100 post HCT
Secondary Outcomes
- Number of Participants With Serious Infections(1 year and 2 years)
- cytomegalovirus (CMV) reactivation(1 year and 2 years)
- grade 2 or higher hemorrhagic cystitis(1 year and 2 years)
- MAGIC algorithm probability (MAP) change(Day 28 post HCT)
- Progression-free survival(1 year and 2 years)
- Number of Participants With Chronic GVHD Requiring Systemic Steroid Treatment(1 year and 2 years)
- Number of Participants With Non-relapse Mortality (NRM)(6 months)
- Number of Participants With Relapse(1 year and 2 years)
- Overall survival(1 year and 2 years)
- GvHD free and relapse free survival(1 year and 2 years)
Investigators
Jie Ji
Principle Investigator
Sichuan University
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 3
Valganciclovir in Prevention of Cytomegalovirus (CMV) Reactivation Following Allogeneic-Stem Cell Transplantation (SCT)Bone Marrow TransplantationCytomegalovirusNCT00330018Hadassah Medical Organization40
Completed
Phase 2
Stem Cell Transplant for High Risk Central Nervous System (CNS) TumorsPineoblastomaGlioblastomaRhabdoid TumorSupratentorial NeoplasmsAstrocytomaNCT00179803Ann & Robert H Lurie Children's Hospital of Chicago24
Not yet recruiting
Phase 3
Outcomes of Patients After Allo-HSCT With Decitabine and NACEngraft FailureRelapseGVHDNCT04945096The First Affiliated Hospital of Soochow University100
Active, not recruiting
Phase 2
Homologous Recombination Repair Status as a Biomarker of Response in Locally Recurrent/Metastatic Triple Negative Breast Cancer Patients Treated With Concurrent Cisplatin and Radiation TherapyLocally Recurrent/Metastatic Triple Negative Breast CancerNCT02422498Memorial Sloan Kettering Cancer Center49
Completed
Phase 2
Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myeloid NeoplasmsBlasts 10 Percent or More of Bone Marrow Nucleated CellsChronic Myelomonocytic Leukemia-2High Grade Malignant NeoplasmMyelodysplastic Syndrome With Excess Blasts-2Myeloid NeoplasmPreviously Treated Myelodysplastic SyndromeRecurrent Acute Myeloid LeukemiaRefractory Acute Myeloid LeukemiaMyelodysplastic SyndromeNCT02756572University of Washington30