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

Recruiting in Palo Alto (17 mi)

Overseen ByMark A Schroeder, M.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Breakthrough Therapy

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Baricitinib 4 mg Dose LevelExperimental Treatment1 Intervention

* 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.

Group II: Baricitinib 2 mg Dose LevelExperimental Treatment1 Intervention

* 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.

Baricitinib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Olumiant for: