MAP-guided Preemptive Therapy of aGvHD by Ruxolitinib

Launched by SICHUAN UNIVERSITY · Oct 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to prevent a condition called acute graft-versus-host disease (aGVHD) in patients who are receiving stem cell transplants. aGVHD can occur when the donor's immune cells attack the recipient's body. The researchers want to see if giving a medication called ruxolitinib, guided by a special algorithm, can help prevent severe cases of aGVHD. Participants in the trial will take ruxolitinib for 28 days, and if they do not show signs of aGVHD, the dose will be gradually reduced over the next 16 days. The goal is to compare those who receive this treatment with those who do not to see if it makes a difference in preventing severe aGVHD.

To be eligible for this trial, participants need to be between the ages of 58 and 91, and they must be undergoing a specific type of stem cell transplant. They should not have any active cases of aGVHD when starting the study and must meet certain health criteria, including having stable liver function. The trial is not yet recruiting participants, but if you or a loved one are interested, this study could provide an opportunity to help improve outcomes for patients receiving stem cell transplants.

Gender

ALL

Eligibility criteria

• 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