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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 01 Oct 2022

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At a glance

  • Drugs Plerixafor (Primary) ; Antineoplastics; Granulocyte colony-stimulating factors
  • Indications Brain cancer; Ewing's sarcoma; Lymphoma; Neuroblastoma; Soft tissue sarcoma; Solid tumours
  • Focus Therapeutic Use
  • Acronyms MOZAIC
  • Sponsors Sanofi; Sanofi Genzyme

    • Most Recent Events

    • 26 Sep 2022 Data were used from this trial for development of a model that could predict CD34(+) harvest volume on first day of apheresis (AP-CD34(+)) based on PB-CD34(+) counts immediately prior to commencing apheresis in pediatric population published in the Bone Marrow Transplantation
    • 03 Mar 2020 Primary endpoint, Proportion of patients achieving at least a doubling of peripheral blood CD34+ count during Stage 2, has been met as per results published in the Bone Marrow Transplantation
    • 03 Mar 2020 Results published in the Bone Marrow Transplantation

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