Status:
WITHDRAWN
Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission.
Lead Sponsor:
Y-mAbs Therapeutics
Conditions:
Neuroblastoma
Eligibility:
All Genders
1+ years
Phase:
PHASE2
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 t...
Eligibility Criteria
Inclusion
- Documentet neuroblastoma at time of diagnosis defined as
- Histopathology of solid tumor biopsy, or
- Bone marrow aspirate or biopsy indicative of neuroblastoma plus high blood or urine catecholamine metabolite levels
- Documented high-risk disease at time of initial diagnosis defined as
- MYNC-amplified at stage L2, M or MS (according to International Neuroblastoma Risk Group (INRG)) of any age or
- MYCN-nonamplified with stage M (according to INRG) and diagnosed at ≥ 18 months of age or
- Patient must have completed frontline therapy, and achieved one of the following:
- verified complete response according to INRC (bone marrow positive minimal residual disease is allowed as assessed by RTqPCR at site) after completion of induction and consolidation with or without autologous stem cell transplantation
- Verified partial response according to INRC for primary site and soft tissue, bone, and bone marrow metastases at pre-autologous stem cell transplantation evaluation (i.e., myeloablative chemotherapy + autologous stem cell transplantation required as part of frontline regimen). Furthermore, bone marrow response must be with ≤ 5% tumor (of total nucleated cellular content) seen on any specimen from a bilateral bone marrow aspirate/biopsy and bone response must be with ≤ 3 areas of abnormal uptake on 123I-MIBG scintigraphy
- Age ≥ 12 months at trial enrollment
Exclusion
- Verified progressive disease during induction or consolidation therapy
- Any systemic anti-cancer therapy, including chemotherapy, within 3 weeks prior to enrollment
- Autologous stem cell transplantation within 6 weeks prior to enrollment or ongoing toxicity caused by the autologous stem cell transplantation at the discretion of the Investigator
- Therapeutic 131I-MIBG within 6 weeks prior to enrollment
- Prior anti-GD2 therapy
- Performance status of \< 50% as per the Lansky scale (patients less than 16 years of age) or Karnofsky scale (patients aged 16 years or older)
Key Trial Info
Start Date :
December 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04909515
Start Date
December 2 2021
End Date
April 1 2027
Last Update
September 1 2022
Active Locations (9)
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1
Hong Kong Children's Hospital
Kowloon, Hong Kong
2
National Medical Research Center Pediatric Hematology, Oncology and Immunology n.a Dmitry Rogachev
Moscow, Russia
3
Research Institute of Pediatric Oncology ad Hematology of N.N. Blokhin National Medical Research Center of Oncology
Moscow, Russia
4
Raisa Gorbacheva Memorial Institute of Children Hematology and Transplantation Bone marrow Transplant Clinic
Saint Petersburg, Russia