NCT01288573

A Combined Study in Pediatric Cancer Patients for Dose Ranging and Efficacy/Safety of Plerixafor Plus Standard Regimens for Mobilization Versus Standard Regimens Alone

A Phase 1/2 Combined Dose Ranging and Randomized, Open-label, Comparative Study of the Efficacy and Safety of Plerixafor in Addition to Standard Regimens for Mobilization of Haematopoietic Stem Cells Into Peripheral Blood, and Subsequent Collection by Apheresis, Versus Standard Mobilization Regimens Alone in Pediatric Patients, Aged 1 to <18 Years, With Solid Tumours Eligible for Autologous Transplants.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-site study with plerixafor in pediatric cancer patients. The study will be conducted in 2 stages: * Stage 1 is a dose-escalation study. * Stage 2 is an open-label, randomized, comparative study using the appropriate dosing regimen identified in the Stage 1 dose-escalation study. All participating patients will receive a standard mobilization regimen as per study site practice guidelines (either chemotherapy plus once daily granulocyte-colony stimulating factor (G-CSF) or once daily G-CSF alone). The only change to the standard mobilization regimen is the addition of plerixafor treatment prior to apheresis for all patients in Stage 1 (dose escalation), and for those patients randomized to the plerixafor plus standard mobilization treatment arm in Stage 2 (randomized, comparative). Stage 1 will enroll at least 27 patients. Stage 2 will enroll at least 40 patients.

Conditions

• Ewing's Sarcoma/Soft Tissue Sarcoma
• Neuroblastoma
• Brain Tumors

Interventions

Type	Name	Description
DRUG	plerixafor	160 μg/kg subcutaneous (SC) injection
DRUG	plerixafor	240 μg/kg subcutaneous (SC) injection
DRUG	plerixafor	320 μg/kg subcutaneous (SC) injection

Timeline

• Start date: 2014-03-03
• Primary completion: 2017-05-09
• Completion: 2017-05-09
• First posted: 2011-02-02
• Last updated: 2017-05-16

Locations

27 sites across 12 countries: Belgium, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Spain, United Kingdom