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

PHASE2CompletedINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

February 7, 2020

Primary Completion Date

February 23, 2023

Study Completion Date

August 22, 2023

Conditions
Cytokine Release Syndrome
Interventions
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.

Trial Locations (10)

10032

Columbia University Medical Center, New York

10065

Memorial Sloan Kettering Cancer Center, New York

19104

University of Pennsylvania Hospital, Philadelphia

33136

University of Miami Sylvester Comprehensive Cancer Center, Miami

33612

Moffitt Cancer Center, Tampa

45229

Cincinnati Childrens Hospital Medical Center, Cincinnati

53226

Medical College of Wisconsin, Milwaukee

63110

Washington University School of Medicine, St Louis

97239

Oregon Health & Science University, Portland

02114

Massachusetts General Hospital, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Incyte Corporation

INDUSTRY