EUCTR2010-019340-40-NL进行中（未招募）1 期
A Phase 1/2 Combined Dose Ranging and Randomised, Open-label, Comparative Study of the Efficacy and Safety of Plerixafor in Addition to Standard Regimens for Mobilisation of Haematopoietic Stem Cells into Peripheral Blood, and Subsequent Collection by Apheresis, Versus Standard Mobilisation Regimens Alone in Paediatric Patients, Aged 1 to <18 Years, with Solid Tumours Eligible for Autologous Transplants - MOZAIC
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age 1 to <18 years
- •2. Ewing’s sarcoma, soft tissue sarcoma, lymphoma, neuroblastoma, or other malignancy including brain tumours
- •(excluding any form of leukaemia) requiring treatment with high dose chemotherapy and autologous transplant as rescue therapy
- •3. Eligible for autologous transplantation
- •4. Recovered from all acute significant toxic effects of prior chemotherapy
- •5. Adequate performance status
- •– for patients =16 years of age, defined as Karnofsky score >60
- •– for patients <16 years of age, defined as Lansky score >60
- •6. Absolute neutrophil count >0.75 × 10P9/L
- •7. Platelet count >50 × 10P9/L
- •8. Calculated creatinine clearance (using the Schwartz method):
- •– during study Stage 2, >60 mL/min/1.73mP2
- •9. Liver functions <3 × upper limit of normal :
- •Aspartate aminotransferase/serum glutamic oxaloacetic transaminase
- •(AST/SGOT), alanine aminotransferase/serum glutamic pyruvic transaminase
- •(ALT/SGPT) and total bilirubin
- •10. The patient and/or their parent/legal guardian is willing and able to provide signed informed consent
- •11. Patients who are sexually active must be willing to abstain from sexual intercourse or agree to use an approved form of contraception while receiving plerixafor and/or standard mobilisation treatment and for at least 3 months following any plerixafor treatment.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 70
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any form of leukaemia
- •2. A co-morbid condition, such as ventricular arrhythmias, which, in the view of the Investigator, renders the patient
- •at high-risk from treatment complications
- •3. Previous stem cell transplantation
- •4. Patients with persistent high percentage marrow involvement prior to mobilisation will be prohibited.
- •5. On-going toxicities (excluding alopecia) Grade =2 resulting from prior chemotherapy
- •6. Acute infection
- •7. Fever (temperature >38.5°C) - if fever is between 37°C and 38.5°C, infection must be excluded as a cause
- •8. Known HIV seropositivity, AIDS, hepatitis C or active hepatitis B infections.
- •9. Positive pregnancy test in post pubertal girls
- •10. History of clinically significant cardiac abnormality or arrhythmia
- •11. Use of an investigational drug which is not approved in any indication either in
- •adults or paediatrics within 2 weeks prior to the first dose of G-CSF to be administered as part of the patient’s planned standard mobilisation regimen, and/or during the study up until engraftment of the transplant. If patients are on
- •investigational drugs as part of their anti-cancer regimen, this should be discussed with the Sponsor before screening. Drugs approved for other indications that are being used in a manner considered standard of care for this transplant procedure are allowed
- •12. The patient (and/or their parent/legal guardian), in the opinion of the Investigator,
- •is unable to adhere to the requirements of the study
研究者
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