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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04731298
Registration number
NCT04731298
Ethics application status
Date submitted
13/11/2020
Date registered
29/01/2021
Date last updated
28/12/2023
Titles & IDs
Public title
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.
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Scientific title
An Open Label, Single Arm, Multicentre, Proof of Concept, Phase 2 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 Allogeneic Hematopoietic Stem Cell Transplantation
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Secondary ID [1]
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NI-0501-12
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Graft Failure
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Emapalumab
Experimental: Emapalumab - The first cohort of patients will receive a first infusion of 6 mg/kg at TD0, followed by a second infusion at 3 mg/kg after 3 days (treatment day 3 - TD3). Subsequent infusions of 3 mg/kg will be every 3 or 4 days from previous dose until dose 15 or until engraftment.
A maximum of 2 additional cohorts may be added to allow dosing regimen adaptation based on the PK/PD data observed from the previous cohort(s). Efficacy and safety data will also be considered before adding additional cohorts.
Treatment: Drugs: Emapalumab
Emapalumab is a fully human immunoglobulin G1 (IgG1) anti-IFN? monoclonal antibody that binds to and neutralizes IFN?. Emapalumab binds to both soluble and receptor (IFN?R1)-bound forms of IFN?.
Emapalumab is in development for treatment of primary and secondary HLH. The benefit expected from the targeted neutralization of IFN? 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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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CXCL9 in Serum
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Assessment method [1]
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Serum concentration of C-X-C Motif Chemokine Ligand 9 (CXCL9)
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Timepoint [1]
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From start of treatment to EoS Visit, up to 34 weeks
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Primary outcome [2]
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Primary Graft Failure (GF)
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Assessment method [2]
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Number of participants with primary graft failure (GF)
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Timepoint [2]
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From Hematopoietic stem-cell transplantation (HSCT) [Day 0] up to study termination, approximately 46 weeks
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Primary outcome [3]
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Secondary GF
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Assessment method [3]
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Number of participants with secondary GF
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Timepoint [3]
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [1]
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Free & Total Interferon Gamma (IFN?) in Serum
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Assessment method [1]
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Serum concentration of free and total Interferon gamma (IFN?)
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Timepoint [1]
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From start of treatment to EoS Visit, up to 34 weeks
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Secondary outcome [2]
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Emapalumab in Serum - Peak
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Assessment method [2]
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Peak emapalumab serum concentration
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Timepoint [2]
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From start of treatment to EoS, up to 34 weeks
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Secondary outcome [3]
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Ctrough (Emapalumab)
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Assessment method [3]
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Concentration just before administration
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Timepoint [3]
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From start of treatment to EoS, up to 34 weeks
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Secondary outcome [4]
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Exploratory Biomarkers: Ferritin
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Assessment method [4]
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Ferritin - serum concentration
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Timepoint [4]
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [5]
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ADA and nAbs
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Assessment method [5]
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Number of participants developing antibodies against emapalumab (antidrug antibodies [ADA]) and Neutralizing antibodies (nAb)
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Timepoint [5]
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From Start of treatment until EoS, up to 34 weeks
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Secondary outcome [6]
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Number of Participants With Mixed Donor Chimerism <10% and <20%
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Assessment method [6]
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Based on unselected leukocytes and based on sorted T cells
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Timepoint [6]
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [7]
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Number of Participants Receiving Thrombopoietic Agents, Stem Cell Boost, Donor Lymphocyte Infusion (DLI)
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Assessment method [7]
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0
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Timepoint [7]
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [8]
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Number of Participants Receiving a Second Allogeneic HSCT
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Assessment method [8]
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0
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Timepoint [8]
0
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [9]
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Number of Participants With Poor Graft Function
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Assessment method [9]
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0
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Timepoint [9]
0
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [10]
0
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Number of Participants With Event Free Engraftment
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Assessment method [10]
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0
defined as absence of GF or graft support
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Timepoint [10]
0
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [11]
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Number of Participants With Acute and/or Chronic Mild to Severe Graft Versus Host Disease (GvHD)
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Assessment method [11]
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0
(grade I to IV)
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Timepoint [11]
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [12]
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Biomarker Levels, in Particular IFNy and CXCL9, as Predictors of Primary and/or Secondary Graft Failure or Acute and/or Chronic GvHD
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Assessment method [12]
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0
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Timepoint [12]
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [13]
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Engraftment Syndrome
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Assessment method [13]
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Number of participants with engraftment syndrome
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Timepoint [13]
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [14]
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Number of Participants With Endothelial Complications
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Assessment method [14]
0
0
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Timepoint [14]
0
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [15]
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Number of Participants With Relapse, Defined as Cumulative Incidence of Reoccurring Underlying Disease
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Assessment method [15]
0
0
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Timepoint [15]
0
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [16]
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Survival Rate
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Assessment method [16]
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Number of patients alive at the end of study.
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Timepoint [16]
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [17]
0
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Change in Body Temperature
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Assessment method [17]
0
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Change from baseline in body temperature
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Timepoint [17]
0
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [18]
0
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Change in Heart Rate
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Assessment method [18]
0
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Change from baseline in heart rate
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Timepoint [18]
0
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [19]
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Change in Blood Pressure
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Assessment method [19]
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Change from baseline systolic and diastolic blood pressure
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Timepoint [19]
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [20]
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Change in Body Weight
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Assessment method [20]
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Change from baseline in body weight
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Timepoint [20]
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [21]
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Change in Hematology: Red Blood Cells (RBC)
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Assessment method [21]
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Change from baseline in Hematology: red blood cells (RBC)
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Timepoint [21]
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [22]
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Change in Hematology: Hematocrit
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Assessment method [22]
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Change from baseline in Hematology: hematocrit
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Timepoint [22]
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [23]
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Change in Hematology: Hemoglobin
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Assessment method [23]
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Change from baseline in Hematology: hemoglobin
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Timepoint [23]
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [24]
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Change in Hematology: Platelets
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Assessment method [24]
0
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Change from baseline in Hematology: platelets
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Timepoint [24]
0
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [25]
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Change in Hematology: White Blood Cells (WBC)
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Assessment method [25]
0
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Change from baseline in Hematology: white blood cells (WBC)
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Timepoint [25]
0
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [26]
0
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Change in Hematology Differential: Lymphocytes
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Assessment method [26]
0
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Change from baseline in Hematology differential: lymphocytes
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Timepoint [26]
0
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [27]
0
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Change in Hematology Differential: Monocytes
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Assessment method [27]
0
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Change from baseline in Hematology differential: monocytes
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Timepoint [27]
0
0
From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [28]
0
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Change in Hematology Differential: Neutrophils
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Assessment method [28]
0
0
Change from baseline in Hematology differential: neutrophils
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Timepoint [28]
0
0
From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [29]
0
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Change in Biochemistry: Ferritin
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Assessment method [29]
0
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Change from baseline in Biochemistry: Ferritin
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Timepoint [29]
0
0
From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [30]
0
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Change in Biochemistry: Glucose
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Assessment method [30]
0
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Change from baseline in Biochemistry: Glucose
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Timepoint [30]
0
0
From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [31]
0
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Change in Biochemistry: C-reactive Protein
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Assessment method [31]
0
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Change from baseline in Biochemistry: C-reactive protein
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Timepoint [31]
0
0
From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [32]
0
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Change in Biochemistry: Sodium
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Assessment method [32]
0
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Change from baseline in Biochemistry: Sodium
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Timepoint [32]
0
0
From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [33]
0
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Change in Biochemistry: Potassium
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Assessment method [33]
0
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Change from baseline in Biochemistry: Potassium
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Timepoint [33]
0
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [34]
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Change in Biochemistry: Chloride
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Assessment method [34]
0
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Change from baseline in Biochemistry: Chloride
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Timepoint [34]
0
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [35]
0
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Change in Biochemistry: Calcium
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Assessment method [35]
0
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Change from baseline in Biochemistry: Calcium
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Timepoint [35]
0
0
From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [36]
0
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Change in Biochemistry: Magnesium
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Assessment method [36]
0
0
Change from baseline in Biochemistry: Magnesium
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Timepoint [36]
0
0
From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [37]
0
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Change in Biochemistry: Phosphate
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Assessment method [37]
0
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Change from baseline in Biochemistry: Phosphate
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Timepoint [37]
0
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [38]
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Change in Biochemistry: Aspartate Aminotransferase (AST)
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Assessment method [38]
0
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Change from baseline in Biochemistry: Aspartate aminotransferase (AST)
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Timepoint [38]
0
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [39]
0
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Change in Biochemistry: Alanine Aminotransferase (ALT)
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Assessment method [39]
0
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Change from baseline in Biochemistry: alanine aminotransferase (ALT)
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Timepoint [39]
0
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [40]
0
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Change in Biochemistry: Gamma-glutamyl Transpeptidase (?GT)
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Assessment method [40]
0
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Change from baseline in Biochemistry: gamma-glutamyl transpeptidase (?GT)
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Timepoint [40]
0
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [41]
0
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Change in Biochemistry: Alkaline Phosphatase (ALP)
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Assessment method [41]
0
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Change from baseline in Biochemistry: alkaline phosphatase (ALP)
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Timepoint [41]
0
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [42]
0
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Change in Biochemistry: Lactate Dehydrogenase (LDH)
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Assessment method [42]
0
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Change from baseline in Biochemistry: lactate dehydrogenase (LDH)
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Timepoint [42]
0
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [43]
0
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Change in Biochemistry: Bilirubin
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Assessment method [43]
0
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Change from baseline in Biochemistry: bilirubin (total, direct and indirect)
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Timepoint [43]
0
0
From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [44]
0
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Change in Biochemistry: Triglycerides
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Assessment method [44]
0
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Change from baseline in Biochemistry: triglycerides
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Timepoint [44]
0
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From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [45]
0
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Change in Biochemistry: Cholesterol
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Assessment method [45]
0
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Change from baseline in Biochemistry: cholesterol (total and high-density lipoprotein [HDL])
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Timepoint [45]
0
0
From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [46]
0
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Change in Biochemistry: Albumin
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Assessment method [46]
0
0
Change from baseline in Biochemistry: Albumin
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Timepoint [46]
0
0
From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [47]
0
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Change in Biochemistry: Creatinine
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Assessment method [47]
0
0
Change from baseline in Biochemistry: Creatinine
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Timepoint [47]
0
0
From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [48]
0
0
Change in Biochemistry: Urea
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Assessment method [48]
0
0
Change from baseline in Biochemistry: Urea
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Timepoint [48]
0
0
From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [49]
0
0
Activated Partial Thromboplastin (aPTT)
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Assessment method [49]
0
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Change from baseline in Coagulation: activated partial thromboplastin (aPTT)
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Timepoint [49]
0
0
From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [50]
0
0
Prothrombin Time (PT)
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Assessment method [50]
0
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Change from baseline in Coagulation: prothrombin time (PT)
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Timepoint [50]
0
0
From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [51]
0
0
Change in Urinalysis: Glucose
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Assessment method [51]
0
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Change from baseline in Urinalysis: Glucose
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Timepoint [51]
0
0
From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [52]
0
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Change in Urinalysis: Blood
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Assessment method [52]
0
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Change from baseline in Urinalysis: Blood
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Timepoint [52]
0
0
From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [53]
0
0
Change in Urinalysis: Protein
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Assessment method [53]
0
0
Change from baseline in Urinalysis: Protein
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Timepoint [53]
0
0
From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [54]
0
0
Change in Urinalysis: Leucocytes
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Assessment method [54]
0
0
Change from baseline in Urinalysis: Leucocytes
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Timepoint [54]
0
0
From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [55]
0
0
Change in Urinalysis: Ketones
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Assessment method [55]
0
0
Change from baseline in Urinalysis: Ketones
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Timepoint [55]
0
0
From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [56]
0
0
Change in Urinalysis: pH
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Assessment method [56]
0
0
Change from baseline in Urinalysis: pH
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Timepoint [56]
0
0
From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [57]
0
0
Change in Urinalysis: Specific Gravity
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Assessment method [57]
0
0
Change from baseline in Urinalysis: specific gravity
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Timepoint [57]
0
0
From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [58]
0
0
Number of Subjects With Change in Donor Chimerism
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Assessment method [58]
0
0
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Timepoint [58]
0
0
From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [59]
0
0
Change in HLA Antibodies
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Assessment method [59]
0
0
Change from baseline in HLA antibodies against donor cells
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Timepoint [59]
0
0
From HSCT (Day 0) up to study termination, approximately 46 weeks
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Secondary outcome [60]
0
0
Change From Baseline in Minimal Residual Disease (MRD)
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Assessment method [60]
0
0
Only in patients presenting malignant disease
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Timepoint [60]
0
0
From HSCT (Day 0) up to study termination, approximately 46 weeks
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Eligibility
Key inclusion criteria
1. Informed consent form signed by the patient (as required by law) or by the patient's
legally authorized representative(s) with the assent of patients who are legally
capable of providing it, as applicable
2. Recipients of allogeneic Hematopoietic Stem Cell Transplantation (HSCT) and at high
risk of graft failure (GF) based on at least one of the following criteria:
- Receiving reduced intensity conditioning (RIC) or non-myeloablative conditioning
(NMA) combined with a non-malignant disease or with a graft from Bone Marrow (BM)
- Ex vivo T cell depleted graft
- Graft from mismatched unrelated or haploidentical donor
- Graft from Umbilical Cord Blood (UCB)
3. Patients requiring allo-HSCT with the following underlying diseases:
- Malignant disease with high risk of GF, i.e. Acute Myeloid Leukemia (AML) and
Acute Lymphoblastic Leukemia (ALL) with primary induction failure, second partial
remission or relapse; Chronic Myeloid Leukemia (CML) in blastic phase
(circulating blast or blast above 5% in biopsy); Non Hodgkin and Hodgkin Lymphoma
and multiple myeloma with primary induction failure, second partial remission or
relapse, myelodysplastic syndromes (MDS) and myeloproliferative disorders (MPD)
with splenomegaly, myelofibrosis with portal hypertension pre-transplant, MDS/MPD
overlap syndromes
- Non-malignant hematological diseases (e.g. autoimmune and metabolic disorders,
aplastic anemia, Sickle cell anemia, Fanconi anemia, Diamond-Blackfan anemia,
thalassemia, osteopetrosis, Wiskott-Aldrich syndrome, severe combined
immunodeficiency, Hemophagocytic lymphohistiocytosis and other immunoregulatory
disorders)
4. Male and female patients
5. Children aged at least 1 year and adults. Once the appropriate dose has been
determined in one of the three cohorts and safety has been assessed by the Independent
Data Monitoring Committee (IDMC), children less than 1 year old may be included in the
study.
6. Females of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, require use of highly effective contraceptive measures from
screening until 6 months after the last study drug administration
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Minimum age
1
Year
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Pregnant (or planning to become pregnant) or lactating female patients
2. Body weight < 3 kg
3. Underlying malignant disease with Karnofsky/Lansky performance status equal or less
than 40 or an Eastern Cooperative Oncology Group (ECOG) performance status equal or
less than 3
4. Patients presenting CXCL9 levels 10 times above the upper limit of the 95% interval
(CI) of the normal range (reported in the CXCL9 assay laboratory manual) within 24
hours prior to HSCT
5. Clinically manifested infections caused by typical and atypical Mycobacteria,
Salmonella, Histoplasma capsulatum and Herpes Zoster on the day of HSCT
6. Active or clinical suspicion of latent tuberculosis
7. Concomitant diseases that in the opinion of the Investigator may interfere with the
assessment of emapalumab safety or efficacy
8. Receipt of a Bacille Calmette-Guerin (BCG) vaccine within 3 months prior to HSCT
9. Receipt of a live or attenuated live (other than BCG) vaccine within 6 weeks prior to
HSCT
10. Current or scheduled administration of therapies known to potentially trigger a
cytokine release syndrome within 21 days from HSCT.
11. Patients having received IFN? during the last 2 weeks prior to HSCT and/or who require
treatment with IFN?.
12. Patients having received emapalumab during the last 6 months prior to HSCT, unless it
is known that emapalumab is no longer detectable.
13. Patients having received kinase inhibitors (Janus kinase inhibitors [JAKi] or bruton
tyrosine kinase inhibitors [BTKi]) one week (or 5 half-lives whichever is greater)
prior to HSCT.
14. Intolerance to antimicrobial and virus infection prophylaxis.
15. Hypersensitivity to emapalumab or any of the excipients.
16. Ongoing participation in an interventional trial or administration of any
investigational drug (within 3 half-lives of the investigational drug) with the
exception of interventional trials involving supportive care such as probiotics or
antiemetics, graft manipulation, or use of new combinations or new dosing of
conventional therapies for conditioning and prophylaxis pre-HSCT.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/05/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
21/04/2022
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Sample size
Target
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Accrual to date
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Final
2
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [2]
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Kids Cancer Centre Sydney Children's Hospital - Randwick
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Recruitment postcode(s) [2]
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2031 - Randwick
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Recruitment outside Australia
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Canada
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Quebec
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Israel
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Haifa
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Israel
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Jerusalem
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Swedish Orphan Biovitrum
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Address
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Commercial sector/Industry
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PRA Health Sciences
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Commercial sector/Industry
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Cytel Inc.
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Other collaborator category [3]
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Commercial sector/Industry
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Q2 Solutions
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Commercial sector/Industry
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ABF Pharmaceutical Services GmbH
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Commercial sector/Industry
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Cromsource
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Other collaborator category [6]
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Commercial sector/Industry
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BioMérieux
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Address [6]
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is designed as an open-label, single arm, proof of concept study in order to
determine the appropriate emapalumab dosing regimen neutralizing IFN? in patients at risk of
GF. Patients presenting CXCL9 levels above a defined threshold and other clinical criteria
will be eligible to receive emapalumab.
Both children and adults, with malignant and non-malignant underlying diseases, receiving
allo-HSCT who are at high risk of GF as defined in the inclusion criteria will be included in
the study. The main objective of the study is to determine the appropriate emapalumab dose
regimen neutralizing interferon gamma (IFN?) activity to pre-empt graft failure post
allo-HSCT in a population with various underlying diseases and at high risk of graft failure
(GF).
Maximum 3 cohorts are foreseen to determine the appropriate dose regimen to pre-emptively
treat patients at risk of primary GF.
Emapalumab will be administered by IV infusion and treatment will last up to 56 days (15
infusions) or until evidence of engraftment.
The study is expected to last approximately 3 years from screening to the last follow-up
phone call for each patient.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04731298
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Tsila Zuckerman, Dr
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Address
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The Rambam Academic Hospital
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04731298
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