Baricitinib for the Prophylaxis of Graft-Versus-Host Disease After Peripheral Blood Hematopoietic Cell Transplantation

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT04131738
Phase
PHASE1
Status
Completed

Conditions

  • Graft Vs Host Disease
  • Graft-versus-host-disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib — DRUG
    Baricitinib may be taken without regard to food. It should be taken at the same time every day.

Study Details

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).

Key Dates

Start date
Apr 7, 2020
Status verified
May 2023
Primary completion
Nov 30, 2021
Completion
Aug 17, 2022

Study Design

Enrollment
26 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Baricitinib 2 mg Dose Level
    * On Day 0 the allograft will be infused per standard institutional practice * Baricitinib will be administered PO at a starting dose of 2 mg daily from Day -3 to Day 100 * After Day 100, for patients already dose reduced to 2 mg daily, reduce baricitinib to 2 mg every other day for one month or 1 mg daily for one month (depending on drug supply) then discontinue.
  • Experimental: Baricitinib 4 mg Dose Level
    * On Day 0 the allograft will be infused per standard institutional practice * Baricitinib will be administered PO at a starting dose of 4 mg daily from Day -3 to Day 100 * After Day 100, for patients at a dose of 4 mg daily, reduce baricitinib to 2 mg daily for one month, then every other day for one month or 1 mg daily for one month (depending on drug supply) then discontinue.

Primary Outcome Measure

Cumulative incidence of graft failure [ Time Frame: 28 days post transplant ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

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By research site
Washington University School of Medicine· St Louis, MO

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