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

Sanofi-aventis0 个研究点目标入组 3 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•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
•10. The patient and/or their parent/legal guardian is willing and able to provide signed informed consent

•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.

发起方