NCT03755414

Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation

A Single-Arm, Open-Label, Pilot Study and Expansion Study of JAK Inhibitor Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this trial, the investigators will begin to explore the possibility that, as in mice, janus kinase inhibitor 1 (JAK1) inhibition with haploidentical-hematopoietic cell transplantation (HCT) may mitigate graft-versus-host-disease (GVHD) and cytokine release syndrome (CRS) while retaining Graft-versus-Leukemia (GVL) and improving engraftment. The purpose of this pilot study is to determine the safety of itacitinib with haplo-hematopoietic cell transplantation (HCT) measured by the effect on engraftment and grade III-IV GVHD.

Conditions

• Acute Myelogenous Leukemia
• Acute Lymphocytic Leukemia
• Myelodysplastic Syndromes
• Non-Hodgkin Lymphoma
• Hodgkin Disease

Interventions

Type	Name	Description
PROCEDURE	Stem cell transplantation	Standard of care
DRUG	Itacitinib	Itacitinib may be taken without regard to food.
OTHER	Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)	* Screening, day 14, day 28, day 42, day 74, day 100, taper period, and follow-up (pilot study) * Screening, day 14, day 28, day 42, day 74, day 100, day 180, taper period, and follow-up period (expansion study)
OTHER	Human Activity Profile	* Screening, day 14, day 28, day 42, day 74, day 100, taper period, and follow-up (pilot study) * Screening, day 14, day 28, day 42, day 60, day 74, day 100, day 180, taper period, and follow-up period (expansion study)

Timeline

• Start date: 2019-09-04
• Primary completion: 2024-04-26
• Completion: 2024-05-26
• First posted: 2018-11-28
• Last updated: 2025-04-06
• Results posted: 2025-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study