Overview

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

Status:
Completed

Trial end date:
2017-05-09

Target enrollment:

Participant gender:

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.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Genzyme, a Sanofi Company

Collaborator:

Sanofi

Treatments:

JM 3100
Plerixafor