Klinische Studie
A Pivotal Phase 2 Trial of Antibody Naxitamab (hu3F8) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients with Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow(Y-mAbs Clinical Trial Protocol 201)YmAbs antibody therapiefor patients with neuroblastoma
Krankheitsentität(en)
Leukämien (Kinder und Jugendliche)
StudientypInterventionsstudiePhase II
StudientypInterventionsstudiePhase II
Wesentliche Einschlusskriterien- Documented diagnosis of Neuroblastoma as defined per INRC
- High-risk Neuroblastoma with either primary refractory disease or
- incomplete response to salvage treatment
- Patients with Age ≥12 months
- Life expectancy ≥6 months
Wesentliche Ausschlusskriterien- Any systemic anti-cancer therapy, including chemotherapy or immunotherapy, within 3 weeks of 1st dose of GM-CSF
- Evaluable Neuroblastoma outside bone and bone marrow
- Actively progressing disease at trial entry according to Park criteria
- Prior treatment with naxitamab
Statusrekrutierend
Ansprechpartner & KontaktUniversitätsklinikum RegensburgPädiatrische Hämatologie, Onkologie und StammzelltransplantationStudienzentrale0941 94412063spoh(at)ukr.de