Y-mAbs Therapeutics
Children and adults diagnosed with high-risk neuroblastoma patients with primary refractory disease or incomplete response to salvage treatment in bone and/or bone marrow will be treated for up to 101 weeks with naxitamab and granulocyte-macrophage colony stimulating factor (GM-CSF). Patients will be followed for up to five years after first dose. Naxitamab, also known as hu3F8 is a humanised monoclonal antibody targeting GD2
Neuroblastoma
GM-CSF + Naxitamab
PHASE2
Each patient will receive treatment for up to 101 weeks following the first Naxitamab administration. After the end of trial visit, each patient will enter a long-term follow-up where they will be monitored for up to 5 years after first treatment cycle. Each investigational cycle is started with 5 days, days -4 to 0, of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) administered at 250 µg/m2/day in advance of the start of Naxitamab administration. GM-CSF is thereafter administered at 500 µg/m2/day on days 1 to 5. As standard treatment, Naxitamab is administered at 3 mg/kg/day on days 1, 3, and 5, totalling 9 mg/kg per cycle. Treatment cycles are repeated every 4 weeks (±1 week) until complete response or partial response followed by 5 additional cycles every 4 weeks (±1 week). Subsequent cycles are repeated every 8 weeks (±2 weeks) through 101 weeks from first infusion at the discretion of the investigator. End of treatment will take place around 8 weeks after the last cycle and thereafter long-term follow-up will continue.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 122 participants |
| Masking : | NONE |
| Primary Purpose : | TREATMENT |
| Official Title : | 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 |
| Actual Study Start Date : | 2018-04-03 |
| Estimated Primary Completion Date : | 2026-04 |
| Estimated Study Completion Date : | 2028-04 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 1 Year |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
WITHDRAWN
University of Florida
Gainesville, Florida, United States, 32611
WITHDRAWN
University of Chicago
Chicago, Illinois, United States, 60637
ACTIVE NOT RECRUITING
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
ACTIVE NOT RECRUITING
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
WITHDRAWN
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
WITHDRAWN
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
RECRUITING
The Hospital for Sick Children
Toronto, Canada, M5G 1X8
RECRUITING
Rigshospitalet
Copenhagen, Denmark, 2100
WITHDRAWN
Timone children's hospital
Marseille, France, 13005
RECRUITING
University Medical Center Hamburg-Eppendorf
Hamburg, Germany,
RECRUITING
Johannes Gutenberg University
Mainz, Germany,
RECRUITING
University Hospital Regensburg
Regensburg, Germany,
RECRUITING
Hong Kong Children's Hospital
Hong Kong, Hong Kong,
ACTIVE NOT RECRUITING
Queen Mary Hospital
Hong Kong, Hong Kong,
RECRUITING
Giannina Gaslini Hospital
Genoa, Italy, 16147
RECRUITING
IRCCS Foundation National Cancer Institute
Milan, Italy, 20133
RECRUITING
Bambino Gesù Pediatric Hospital
Rome, Italy,
RECRUITING
Hospital Sant Joan de Déu
Barcelona, Spain, 08950
RECRUITING
Niño Jesús University Children's Hospital
Madrid, Spain, 28009
RECRUITING
Virgen del Rocío University Hospital
Sevilla, Spain,
RECRUITING
La Fe University and Polytechnic Hospital
Valencia, Spain, 46026
RECRUITING
The Royal Glasgow Children's Hospital
Glasgow, United Kingdom, G51 4TF
RECRUITING
Leeds General Infirmary
Leeds, United Kingdom, LS1 3EX
WITHDRAWN
The Royal Marsden
London, United Kingdom, Jaya Taj
RECRUITING
University Hospital Southampton
Southampton, United Kingdom, SO16 6YD