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plerixafor

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

Ensayo de Sanofi en Ewing's Sarcoma/Soft Tissue Sarcoma · Neuroblastoma · Brain Tumors (del registro, en inglés).

Fase

Fase 1/2

Estado

Completado

Participantes

46

previstos

Centros

27

Fin del objetivo primario

may 2017

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en mar 2014.

Qué mide

Proportion of patients achieving at least a doubling of peripheral blood CD34+ count during Stage 2 (del registro, en inglés) (hasta 5 dias)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01288573), actualizada en may 2017.