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Brief Title: Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission.
Official Title: Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission. An International, Open-Label,Uncontrolled, Single-Arm, Multicenter, Phase 2 Trial
Study ID: NCT04909515
Brief Summary: This is a single-arm, uncontrolled, international, multi-center, clinical,phase 2 trial, in patients ≥ 12 months of age with high-risk neuroblastoma in first remission. 120 patients will be enrolled to receive naxitamab + GM-CSF in combination with isotretinoin.
Detailed Description:
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hong Kong Children's Hospital, Kowloon, , Hong Kong
Asan Medical Center Childrens Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Soeul, , Korea, Republic of
National Medical Research Center Pediatric Hematology, Oncology and Immunology n.a Dmitry Rogachev, Moscow, , Russian Federation
Research Institute of Pediatric Oncology ad Hematology of N.N. Blokhin National Medical Research Center of Oncology, Moscow, , Russian Federation
Raisa Gorbacheva Memorial Institute of Children Hematology and Transplantation Bone marrow Transplant Clinic, Saint Petersburg, , Russian Federation
ICON Cancer Centre Novena, Singapore, , Singapore
KK Women's and Children's Hospital, Singapore, , Singapore