Study to Investigate the Pharmacokinetics, Pharmacodynamics and Assess the Efficacy and Safety to Support Dose Selection of Emapalumab in Pre-empting Graft Failure in Patients at High Risk After HSCT.

PHASE2TerminatedINTERVENTIONAL
Enrollment

2

Participants

Timeline

Start Date

May 25, 2021

Primary Completion Date

April 21, 2022

Study Completion Date

April 21, 2022

Conditions
Graft Failure
Interventions
DRUG

Emapalumab

"Emapalumab is a fully human immunoglobulin G1 (IgG1) anti-IFNγ monoclonal antibody that binds to and neutralizes IFNγ. Emapalumab binds to both soluble and receptor (IFNγR1)-bound forms of IFNγ.~Emapalumab is in development for treatment of primary and secondary HLH. The benefit expected from the targeted neutralization of IFNγ by emapalumab has been validated by the recent FDA approval of emapalumab for treatment of patients with pHLH who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. The safety profile has been assessed as acceptable.~Emapalumab will be administered by intravenous infusion over 1 to 2 hours, depending on the volume of the infusion. The first infusion must be performed within 12 hours after CXCL9 levels have been measured above defined threshold. Treatment will last until maximum dose 15 (up to 56 days) or until evidence of engraftment, whichever comes first."

Trial Locations (5)

2031

Kids Cancer Centre Sydney Children's Hospital, Randwick

3000

Peter MacCallum Cancer Centre, Melbourne

31096

The Rambam Academic Hospital, Haifa

91120

Hadassah Hebrew University, Jerusalem

H3T 1C5

CHU Sainte-Justine, Montreal

All Listed Sponsors
collaborator

PRA Health Sciences

INDUSTRY

collaborator

Cytel Inc.

INDUSTRY

collaborator

Q2 Solutions

INDUSTRY

collaborator

ABF Pharmaceutical Services GmbH

INDUSTRY

collaborator

Cromsource

INDUSTRY

collaborator

BioMérieux

INDUSTRY

lead

Swedish Orphan Biovitrum

INDUSTRY