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plerixafor GZ316455

Plerixafor Plus Granulocyte Colony-Stimulating Factor For Mobilization And Collection Of Peripheral Hematopoietic Stem Cells In Japanese Participants With Non-Hodgkin Lymphoma

Ensayo de Sanofi en Linfoma.

Más ensayos de: Linfoma.

Fase

Fase 2

Estado

Completado

Participantes

32

previstos

Centros

12

Fin del objetivo primario

mar 2016

fecha real

Qué significa cada fase y cada estado.

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

Qué mide

Proportion of participants who achieve a collection of greater than or equal to 5 x10^6 cells/kg CD34+ cells in less than or equal to 4 days of apheresis (Day 5 to Day 8 of the apheresis/treatment period) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: To determine if non-Hodgkin Lymphoma (NHL) participants mobilized with granulocyte colony-stimulating factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a target number of greater than or equal to 5 x 10\^6 cluster differential (CD) 34+ cells/kg in 4 or fewer days of apheresis than NHL participants mobilized with G-CSF alone. Secondary Objectives: * To evaluate the safety of G-CSF plus plerixafor arm compared to G-CSF arm in NHL participants. * To compare the 2 treatment arms with respect to the number of participants who achieved a minimum of 2 x 10\^6 CD34+ cells/kg in 4 or fewer days of apheresis. * To compare the 2 treatment arms with respect to the number of days of apheresis required to reach the target of greater than or equal to 5 x 10\^6 CD34+ cells/kg.

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Ficha completa en ClinicalTrials.gov (NCT02221492), actualizada en mar 2016.