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A Phase 4, Multicenter, Randomized, Comparator Trial Evaluating the Standard Weight-Based Dose (0.24 mg/kg) Compared to a Fixed Dose (20 mg) of Plerixafor Injection in Combination With G-CSF to Mobilize and Collect ≥5 x 10^6 CD34+ Cells/kg in ≤4 Days and to Evaluate the Difference in Total Systemic Exposure in Patients With Non-Hodgkin's Lymphoma Weighing ≤70 kg

Trial Profile

A Phase 4, Multicenter, Randomized, Comparator Trial Evaluating the Standard Weight-Based Dose (0.24 mg/kg) Compared to a Fixed Dose (20 mg) of Plerixafor Injection in Combination With G-CSF to Mobilize and Collect ≥5 x 10^6 CD34+ Cells/kg in ≤4 Days and to Evaluate the Difference in Total Systemic Exposure in Patients With Non-Hodgkin's Lymphoma Weighing ≤70 kg

Completed
Phase of Trial: Phase IV

Latest Information Update: 05 Jul 2018

At a glance

  • Drugs Filgrastim (Primary) ; Plerixafor (Primary)
  • Indications Stem cell mobilisation
  • Focus Pharmacokinetics; Therapeutic Use
  • Sponsors Sanofi; Sanofi Genzyme
  • Most Recent Events

    • 31 Aug 2018 Biomarkers information updated
    • 05 Jul 2018 New trial record
    • 12 Jun 2018 Primary endpoint (Proportion of Patients Who Achieved at Least 5*10^6 Cluster of Differentiation 34+ (CD34+) Cells Per Kilogram (Cells/kg):Fixed Dose (FD) Plerixafor versus Weight-Based (WB) Plerixafor) has not been met, according to results published in the Bone Marrow Transplantation.
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