EUCTR2010-019340-40-ES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 2 to <18 Years, with Solid Tumours Eligible for Autologous Transplants
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
- 67
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. Age 2 to <18 years
- •2. Ewing?s sarcoma, soft tissue sarcoma, neuroblastoma, brain tumours or other
- •malignancy (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 >1.0 × 10P9/L
- •7. Platelet count >75 × 10P9/L
- •8. Calculated creatinine clearance (using the Schwartz method):
- •? during study Stage 1, >80 mL/min/1.73mP2
- •? during study Stage 2, >60 mL/min/1.73mP2
- •9. Aspartate aminotransferase/serum glutamic oxaloacetic transaminase
- •(AST/SGOT), alanine aminotransferase/serum glutamic pyruvic transaminase
- •(ALT/SGPT) and total bilirubin <3 × upper limit of normal
- •10. The patient and/or their parent/legal guardian is willing and able to provide signed informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 67
- •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 which, in the view of the Investigator, renders the patient
- •at high-risk from treatment complications
- •3. Previous stem cell transplantation
- •4. Patients with tumours frequently involving bone marrow (e.g., lymphomas and
- •neuroblastoma) will be expected to have had evaluation of their marrow as part of
- •their standard staging evaluations. Persistent high percentage marrow
- •involvement prior to mobilisation will be prohibited. (Specific guidelines for
- •different indications are provided in Section 9.2.1 with details of bone marrow
- •examination requirements at Screening)
- •5. A residual acute medical condition 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. Pulse oximetry ?92%
- •9. Known HIV positive
- •10. Positive pregnancy test in post pubertal girls
- •11. History of clinically significant cardiac abnormality or arrhythmia
- •12. Use of an investigational drug which is not approved in any indication either in
- •adults or paediatrics within 4 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. Drugs approved
- •for other indications that are being used in a manner considered standard of care
- •for this transplant procedure are allowed
- •13. 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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