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Alemtuzumab plus Fludarabine · ECO-1

Alemtuzumab/Fludarabine for Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)

Ensayo de Sanofi en Leukemia, Lymphocytic, Chronic, B-Cell (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

60

previstos

Centros

27

Fin del objetivo primario

abr 2008

fecha real

Qué significa cada fase y cada estado.

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

Qué mide

Complete Response (CR) (28 days after last cycle with confirmation 2 months later) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a multi-center, Phase II, open label trial evaluating the efficacy and safety of alemtuzumab and fludarabine in the treatment of B-cell chronic lymphocytic leukemia (B-CLL) patients who have received at least one prior therapy. Treatments will be administered on a 28-day cycle for 4-6 cycles, with an evaluation during Cycle 4 to permit re-staging. Alemtuzumab and fludarabine will be administered on Days 1-5 of each cycle. Patients will be assessed for response at the time of re-staging at Cycle 4 and at the end of Cycle 6. At the time of the re-staging, patients achieving a Partial Remission (PR) or Stable Disease (SD) will be given an additional 2 cycles of treatment and patients demonstrating presumptive signs of a Complete Remission (CR) will receive no further treatment but will be followed for response.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00206726), actualizada en jul 2016.