In this trial, the investigators will begin to explore the possibility that, as in mice, JAK1/2 inhibition with hematopoietic cell transplantation (HCT) may mitigate graft-versus-host-disease (GVHD) while retaining engraftment and Graft-versus-Leukemia (GVL). Both preclinical and clinical data suggest that inhibition of IFNy and IL-6, directly and using downstream JAK Inhibitors, may be an effective strategy to decrease toxicities and improve disease control for patients undergoing Allogeneic HSCT. Baricitinib, as a JAK1/2 inhibitor, has shown superiority to other JAK inhibitors in preclinical GVHD models. The purpose of this phase I clinical trial is to determine the safety of baricitinib with HSCT measured by the effect on engraftment and grade III-IV acute graft-versus-host-disease (aGVHD).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Baricitinib may be taken without regard to food. It should be taken at the same time every day.
Washington University School of Medicine
St Louis, Missouri, United States
Cumulative incidence of graft failure
-Failure to engraft will be defined as failure to achieve absolute neutrophil count \> 500 for 3 days by Day 28.
Time frame: 28 days post transplant
Cumulative incidence of grade III-IV acute GVHD
-Acute GVHD will be assessed using MAGIC criteria
Time frame: Day 100
Treatment related mortality
-Death that results from a transplant procedure-related complication (e.g. infection, organ failure, hemorrhage, GVHD) rather than from relapse of the underlying disease or an unrelated cause.
Time frame: Day 180
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