A Clinical trial to compare Acalabrutinib (ACP-196) versus investigator's choice standard treatment with Bendamustine/Rituximab or Idelalisib/Rituximab alone in patients with with Relapsed or Refract...

Mise à jour : Il y a 4 ans
Référence : EUCTR2015-004454-17

A Clinical trial to compare Acalabrutinib (ACP-196) versus investigator's choice standard treatment with Bendamustine/Rituximab or Idelalisib/Rituximab alone in patients with with Relapsed or Refractory Chronic Lymphocytic Leukemia

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Extrait

To evaluate the efficacy of acalabrutinib monotherapy (Arm A) compared with idelalisib/rituximab or bendamustine/rituximab (Arm B) based on Independent Review Committee (IRC) assessment of progression-free survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria (Hallek 2008) with incorporation of the clarification for treatment-related lymphocytosis (Cheson 2012)—hereafter referred to as IWCLL 2008 criteria in subjects with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL).


Critère d'inclusion

  • Relapsed or Refractory Chronic Lymphocytic Leukemia