NCT04071366

A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy

A Phase 2 Study of Itacitinib, for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

"The purpose of this study is to assess the safety and efficacy of oral administration of itacitinib for the prevention of cytokine release syndrome (CRS) in male or female participants aged 12 years or older and who are planning to receive an approved immune effector cell (IEC) therapy for hematologic malignancies.

Conditions

• Cytokine Release Syndrome

Interventions

Type	Name	Description
DRUG	Itacitinib	Part 1: Itacitinib 200 mg once daily for 30 days. Part 2: Itacitinib 200 mg twice daily for 30 days.
DRUG	Immune effector cell therapy	Participants will receive IEC therapy that is approved by the health authority in the country where the study is being conducted for any approved hematologic indication.
DRUG	Placebo	Participants will receive placebo twice daily.
BIOLOGICAL	Yescarta	Eligible participants are receiving Yescarta (An infusion of chimeric antigen receptor (CAR)-transduced autologous T cells) for relapsed or refractory larbe B-cell lymphoma or follicular lymphoma intravenously.

Timeline

• Start date: 2020-02-07
• Primary completion: 2023-02-23
• Completion: 2023-08-22
• First posted: 2019-08-28
• Last updated: 2024-03-26
• Results posted: 2024-03-26

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study