University Medical Center Hamburg-Eppendorf Hamburg (Hamburg) GermanyRekrutierend» Google-MapsJohannes Gutenberg-Universität Mainz (Rheinland-Pfalz) GermanyRekrutierend» Google-MapsUniversity Hospital Regensburg Regensburg (Bayern) GermanyRekrutierend» Google-Maps
University of Florida 32611 Gainesville United StatesZurückgezogen» Google-MapsUniversity of Chicago 60637 Chicago United StatesZurückgezogen» Google-MapsRiley Hospital for Children 46202 Indianapolis United StatesAktiv, nicht rekrutierend» Google-MapsMemorial Sloan Kettering Cancer Center 10065 New York United StatesAktiv, nicht rekrutierend» Google-MapsNationwide Children's Hospital 43205 Columbus United StatesZurückgezogen» Google-MapsM.D. Anderson Cancer Center 77030 Houston United StatesZurückgezogen» Google-MapsThe Hospital for Sick Children M5G 1X8 Toronto CanadaRekrutierend» Google-MapsRigshospitalet 2100 København DenmarkRekrutierend» Google-MapsHopital pour enfants de la Timone 13005 Marseille FranceRekrutierend» Google-MapsHong Kong Children's Hospital Hong Kong Hong KongRekrutierend» Google-MapsQueen Mary Hospital Hong Kong Hong KongAktiv, nicht rekrutierend» Google-MapsGiannina Gaslini Hospital 16147 Genoa ItalyRekrutierend» Google-MapsFondazione IRCCS Istituto Nazionale dei Tumori 20133 Milan ItalyRekrutierend» Google-MapsHospital Sant Joan de Déu 08950 Barcelona SpainRekrutierend» Google-MapsHospital Infantil Universitario Niño Jesús 28009 Madrid SpainRekrutierend» Google-MapsHospital Universitario Virgen Del Rocío Sevilla SpainNoch nicht rekrutierend» Google-MapsHospital Universitario y Politécnico La Fe 46026 Valencia SpainRekrutierend» Google-MapsThe Royal Glasgow Children's Hospital G51 4TF Glasgow United KingdomRekrutierend» Google-MapsLeeds General Infirmary LS1 3EX Leeds United KingdomRekrutierend» Google-MapsThe Royal Marsden SW3 6JJ London United KingdomZurückgezogen» Google-MapsUniversity Hospital Southampton SO16 6YD Southampton United KingdomRekrutierend» Google-Maps
1. Response rate during Naxitamab treatment (Time Frame - 101 weeks): Overall objective response rate (ORR) during the Naxitamab treatment period that will be centrally assessed according to the International Neuroblastoma Response Criteria (INRC) modified with 123I-MIBG criteria and following the use of 18F FDG-PET for MIBG non-avid lesions.
Secondary outcome:
1. Incidence of adverse events and serious adverse events (Time Frame - 101 weeks): Safety will be evaluated by the incidence of adverse events (AE) and serious adverse events (SAEs) graded according to CTCAE, version 4.0.
2. Duration of Response (DoR) (Time Frame - 101 weeks): Length of time from patient response to disease progression.
3. Complete Response Rate (Time Frame - 101 weeks): The complete response (CR) rate is defined as the fraction of patients experiencing a CR according to International Neuroblastoma Response Criteria (INRC) criteria during the treatment period.
4. Assessment of the maximum serum concentration (cmax) of naxitamab (Time Frame - Pre-naxitamab dose - 552 hours): Calculation of maximum serum concentration of naxitamab will be calculated and summarized with descriptive statistics.
5. Assessment of the minimum serum concentration (cmin) of naxitamab (Time Frame - Pre-naxitamab dose - 552 hours): Calculation of minimum serum concentration of naxitamab will be calculated and summarized with descriptive statistics.
6. Assessment of the clearance of naxitamab (Time Frame - Pre-naxitamab dose - 552 hours): Calculation of clearance of naxitamab will be calculated and summarized with descriptive statistics.
7. Assessment of the volume of distribution of naxitamab (Time Frame - Pre-naxitamab dose - 552 hours): Calculation of the volume of distribution of naxitamab will be calculated and summarized with descriptive statistics.
8. Assessment of the Area under the Curve (AUC) of naxitamab (Time Frame - Pre-naxitamab dose - 552 hours): Calculation of the AUC of naxitamab will be calculated and summarized with descriptive statistics.
9. Assessment of the terminal half-life (t½) of naxitamab (Time Frame - Pre-naxitamab dose - 552 hours): Calculation of the t½ of naxitamab will be calculated and summarized with descriptive statistics.
10. Assessment of anti-drug antibody (ADA) formation (Time Frame - Pre-naxitamab dose - 552 hours): ADA formation will be investigated following a multi-tiered approach: A screening confirmation-titration analysis plus a ligand binding assay to examine a potential neutralizing effect of anti-naxitamab antibodies.
11. Intravenous (IV) opioid use (cycle 1) (Time Frame - 6 hours): IV opioid use during cycle 1 defined as total dosage of IV morphine (or equivalent opioid) administered 2 hours before infusion until 4 hours after end of infusion of naxitamab
12. Intravenous (IV) opioid use (all cycles) (Time Frame - 101 weeks): IV opioid use for each cycle during the trial defined as total dosage of IV morphine (or equivalent opioid) administered 2 hours before infusion until 4 hours after end of infusion of naxitamab
13. Hospitalization days (cycle 1) (Time Frame - 4 weeks): Number of hospitalization days related to naxitamab during cycle 1, defined as number of overnight stays. Hospitalizations required solely for protocol-specified assessments (e.g., PK sampling) or non-medical circumstances are excluded
14. Safety of patients with positive human anti-drug antibody (ADA) (Time Frame - 101 weeks): In patients with positive ADA at trial inclusion, safety will be evaluated by the incidence of AEs and SAEs graded according to CTCAE, version 4.0
15. Number of infusions done in an outpatient setting (Time Frame - 101 weeks): Number of infusions done in an outpatient setting
16. Percentage of infusions done in an outpatient setting (Time Frame - 101 weeks): Percentage of infusions done in an outpatient setting
17. Incidence of adverse events and serious adverse events in ADA positive patients (Time Frame - 101 weeks): Safety will be evaluated by the incidence of adverse events (AE) and serious adverse events (SAEs) graded according to CTCAE, version 4.0 in ADA positive patients.
18. Progression Free Survival (PFS) (Time Frame - 5 years): PFS, defined as the time from the first 1st infusion of naxitamab until progressive disease or death, whichever comes first
19. Overall Survival (Time Frame - 5 years): The interval from the date of first dose of Naxitamab until the date of death due to any cause.
20. Happiness and activity levels (Time Frame - 39 days): Happiness and activity levels will be measured over time and assessed by caretaker
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"Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow"
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