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G-CSF plus plerixafor

AMD3100 (Plerixafor) With G-CSF in Poor Mobilizing Adult Patients Who Previously Failed Hematopoietic Stem Cell (HSC) Collection/Attempts

Ensayo de Sanofi en Autologous Stem Cell Transplantation (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

100

previstos

Centros

8

Fin del objetivo primario

dic 2009

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en oct 2005.

Qué mide

Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment Period (Day 1 to approximately day 38) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study evaluates the safety, efficacy, and pharmacokinetics (PK) of plerixafor given in addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells (PBSCs) for autologous transplantation in patients who would benefit from an autologous stem cell transplant but have failed previous collections or collection attempts with a mobilization regimen of G-CSF alone, chemotherapy and G-CSF, or any other conventional therapy including cytokines, chemotherapy and cytokines and bone marrow harvests. The only change to standard of care of a mobilization regimen that includes G-CSF is the addition of a dose of AMD3100 (plerixafor) on the evening prior to each day of apheresis. Efficacy outcomes include quantification of CD34+ cells in the apheresis product and assessment of successful polymorphonuclear leukocyte (PMN) and platelet (PLT) engraftment after transplantation. PK outcomes include analysis of repeated doses of plerixafor.

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Ficha completa en ClinicalTrials.gov (NCT00396331), actualizada en feb 2014.