Status:
RECRUITING
Clinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory/ Relapsed Neuroblastoma
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Hainan General Hospital
Conditions:
Neuroblastoma
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
This is an prospective study to evaluate the safety and efficacy of naxitamab monotherapy or combined with chemotherapy or combined with chemotherapy and checkpoint inhibitor in the treatment of pedia...
Detailed Description
Patients with high risk neuroblastoma who obtain CR after chemotherapy combined with surgery, radiotherapy and/or hematopoietic stem cell transplantation received axitamab and GM-CSF. Patients with hi...
Eligibility Criteria
Inclusion
- 1)Confirmed diagnosis of high-risk NB 2)1 year of age or above 3)Patient or parent/guardian must provide written informed consent to participate 4)If patient is sexually active, the patient agrees to use effective contraception 5)Confirmed negative urine pregnancy test for sexually active female of child-bearing potential (post-menarche)
Exclusion
- Significant organ toxicity
- Known or suspected allergy or hypersensitivity to anti-GD2 antibodies or to GM-CSF or its s components.
- Patient is pregnant, planning to become pregnant (while being treated with naxitamab) or is currently breastfeeding
- Patient will undergo treatment with another investigational drug, whilst being treated with naxitamab or has received another investigational drug within the 4 weeks prior to commencing treatment with naxitamab
- Patient is either eligible and able to participate in or is currently participating in an active interventional Y-mAbs sponsored clinical trial with naxitamab within the indication applied for
- Patient is unable to comply with the naxitamab treatment or has a medical condition that would potentially increase the severity of the toxicities experienced from naxitamab treatment at the discretion of the treating physician
- Left ventricular ejection fraction of \<50% by echocardiography OR other clinically relevant cardiac disorders at the discretion of the investigator
- Inadequate pulmonary function defined as evidence of dyspnea at rest, exercise intolerance, and/or chronic oxygen requirement. In addition, room air pulse oximetry \< 94% and/or abnormal pulmonary function tests if these assessments are clinically indicated
- Applicable for treatment with naxitamab in combination with GM-CSF only:
- Patient has active progression of the NB disease
- Patient has active NB disease at primary site or soft-tissue metastasis
- Patient has known CNS metastases when initiating naxitamab treatment
Key Trial Info
Start Date :
June 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06013618
Start Date
June 19 2023
End Date
December 31 2027
Last Update
June 17 2025
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060