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Plerixafor

Study of Plerixafor Combined With Cytarabine and Daunorubicin in Patients With Newly Diagnosed Acute Myeloid Leukemia

Ensayo de Sanofi en Leucemia mieloide aguda.

Más ensayos de: Leucemia mieloide aguda.

Fase

Fase 1

Estado

Completado

Participantes

36

previstos

Centros

8

Fin del objetivo primario

mar 2012

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en dic 2009.

Qué mide

Determine the maximum tolerated dose of plerixafor when used in combination with cytarabine and daunorubicin and with and without GCSF (28 days from first dose and up to 42 days following last dose) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of this research study is to determine if plerixafor can make cells more sensitive to killing by cytarabine and daunorubicin, an anti-cancer drug regimen referred to as "7+3" that is commonly used in treating acute myeloid leukemia (AML). In this study, plerixafor is used with treatments cytarabine and daunorubicin and with and without granulocyte-colony stimulating factor (GCSF). Subjects will be monitored to see how well they tolerate the use of these drugs together and how well they work to treat the leukemia. The purpose of the study is to determine the maximum tolerated dose (MTD) per plerixafor dosing schedule (once daily \[QD\] or twice daily \[BID\]), and/or recommended phase 2 dose (RP2D), by assessing safety and tolerability of plerixafor (Mozobil®) when used in combination with cytarabine and daunorubicin, and with and without granulocyte-colony stimulating factor (G-CSF)

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00990054), actualizada en mar 2015.