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G-CSF Plus Plerixafor

AMD3100 (Plerixafor) Added to a Mobilizing Regimen of Granulocyte-colony Stimulating Factor (G-CSF) to Increase the Number of Peripheral Blood Stem Cells (PBSCs) in Patients With Hodgkin's Disease

Ensayo de Sanofi en Hodgkin's Disease (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

22

previstos

Centros

1

Fin del objetivo primario

oct 2006

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en nov 2004.

Qué mide

Proportion of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF (Day 5 up to Day 9) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroParticipants with Hodgkin's Disease (HD) who have been treated with cyto-reductive chemotherapy, who are to undergo autologous stem cell transplantation, and who meet the inclusion/exclusion criteria are eligible to enter this efficacy, safety and pharmacokinetic (PK) study. The only changes to the standard of care is the addition of plerixafor to a granulocyte-colony stimulating factor (G-CSF) mobilization regimen on each day prior to apheresis. The purpose of this protocol is to determine the proportion of participants who reach a target number of CD34+ stem cells (≥5\*10\^6 cells/kg) after hematopoietic stem cell mobilization with G-CSF and plerixafor. Safety and PK parameters are also collected.

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Ficha completa en ClinicalTrials.gov (NCT00396201), actualizada en feb 2014.