EUCTR2017-001829-40-GB进行中（未招募）1 期
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 Therapeutics A/S0 个研究点目标入组 95 人开始时间: 2017年10月9日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 95
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Documented diagnosis of neuroblastoma (NB) as defined per INRC as
- •a. histopathology of tumor biopsy, or
- •b. Bone marrow (BM) aspirate or biopsy indicative of NB by histology,
- •plus high blood or urine catecholamine metabolite levels or
- •Myelocytomatosis Viral-Related Oncogene, Neuroblastoma derived
- •(MYCN) amplification, or
- •c. MIBG-avid lesion(s)
- •2. High-risk NB with either primary refractory or secondary refractory
- •incomplete response to salvage treatment (in both cases including SD,
- •MR and PR) evaluable in bone and/or BM as defined in section 6.7. If
- •disease is only present in bone the patient must have evaluable disease
- •outside the radiation areas for being eligible in the trial, please see
- •section 7.2.1. If disease is only present in the BM the involvement must
- •3. Life expectancy =6 months
- •4. Age =12 months
- •5. Acceptable hematological status, (hematological support is allowed if administered =1 week before first infusion of naxitamab), defined as:
- •a. Hemoglobin =8 g/dL (5.0 mmol/L)
- •b. White blood cell count =1000/µL
- •c. Absolute neutrophil count (ANC) =500/µL
- •d. Platelet count =25,000/µL
- •6. Acceptable liver function defined as:
- •a. Alanine aminotransferase (ALT) and aspartate aminotransferase
- •(AST) =5 times upper limit of normal (ULN)
- •b. Bilirubin =1.5 x ULN
- •7. Acceptable kidney function defined as:
- •a. Estimated Glomerular Filtration Rate (eGFR) >60 mL/min/1.73 m2
- •calculated by the 2009 revised Bedside Schwartz Equation
- •8. Written informed consent from legal guardian(s) and/or patient in
- •accordance with local regulations. Children must provide assent as
- •required by local regulations.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 95
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Any systemic anti-cancer therapy, including chemotherapy or immunotherapy, within 3 weeks of 1st dose of GM-CSF
- •2. Evaluable NB outside bone and BM defined as follows:
- •MIBG-avid tumor: Definite MIBG uptake in tumor tissues outside bone
- •MIBG nonavid tumor: Definite uptake in tumor tissues outside bone
- •and BM on FDG-PET
- •3. Actively Progressive Disease at trial entry
- •4. Existing major organ dysfunction CTCAE >Grade 2, with the exception of hearing loss, hematological status, kidney and liver function.
- •5. Active life-threatening infection
- •6. Prior treatment with naxitamab
- •7. Karnofsky/Lansky score <50%
- •8. Pregnancy or a woman who is breast-feeding (women of child-bearing
- •potential must have a negative pregnancy test at screening). A woman of child-bearing potential is excluded if she does not agree to use highly effective contraception for a period of 40 days after the last naxitamab infusion section 9.2.5 in protocol. A sterilized or infertile woman is exempt from the requirement to use contraception after hu3F8 treatment: she must have undergone surgical sterilization
- •(hysterectomy, or bilateral ovariectomy)
- •9. Inability to comply with protocol requirements, including PK studies,
- •as determined by the investigator
- •10. History of allergy or known hypersensitivity to GM-CSF, yeast derived
- •products, or any component of the GM-CSF or naxitamab
- •11. History of anaphylactic reactions CTCAE grade 4 related to prior GD2 antibody therapy.
- •12. NB in central nervous system (CNS) within 6 months of 1st dose of GM-CSF
- •13. Prior treatment with omburtamab (mu8H9) within 6 months of 1st dose of GM-CSF
- •14. Patients who have had allogeneic hematopoietic stem cell
- •transplantation (allo-SCT) or donor-lymphocyte-infusion (DLI). DLI or
- •buffy coat infusion is defined as any kind of active allogenic lymphocyte
- •a. within 6 months of 1st dose of GM-CSF or
- •b. with a lymphocyte count < 0.2 x109/L
- •15. Patients who received Hematopoietic Progenitor Cell (HPC) boost or
- •top-up of allogenic stem cells (lymphocyte-depleted) within 2 months
- •of 1st dose GM-CSF.
- •16. Any clinically meaningful abnormal finding in physical examination,
- •vital signs, ECG, hematology, clinical chemistry, or urinalysis prior to
- •inclusion into the trial, which in the opinion of the investigator, may put
- •the subject at risk because of his/her participation in the study
研究者
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