Calendario›SNY›clofarabine
clofarabine
A Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Children With Acute Leukemias.
Ensayo de Sanofi en Acute Lymphoblastic Leukemia · Acute Myelogenous Leukemia · Relapsed Leukemia (del registro, en inglés).
Más ensayos de: Leucemia linfoblástica aguda · Leucemia mieloide aguda.
- Fase
- Fase 1/2
- Estado
- Completado
- Participantes
- 50
- Centros
- 13
- Fin del objetivo primario
- may 2010
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en mar 2006.
Qué mide
Maximum Tolerated Dose (MTD) in Phase 1 (Up to Day 42 (Phase 1 portion of study)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroClofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted. The purpose of the phase 1 portion of this study was to determine if clofarabine added to a combination of etoposide and cyclophosphamide is safe in children with relapsed or refractory acute lymphoblastic leukemia (ALL) or acute myelogenous leukemia (AML). The purpose of the phase 2 portion of the study was to measure the effectiveness of the combination therapy in children with ALL.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00315705), actualizada en mar 2014.