A study to evaluate use of PCI-32765 (Ibrutinib) in Patients with Leukemia

Mise à jour : Il y a 4 ans
Référence : EUCTR2012-004476-19

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Extrait

The primary objective of this study is to evaluate the efficacy of PCI-32765 in terms of ORR according to an Independent Review Committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria in subjects with relapsed or refractory CLL/Small Lymphocytic Lymphoma (SLL) with 17p deletion as determined by fluorescence in situ hybridization (FISH) as determined by central laboratory analysis, who have received a minimum of 1 prior line of systemic treatment.


Critère d'inclusion

  • An Open-label, Single arm, Multicenter Phase 2 Study of the Bruton’s Tyrosine Kinase Inhibitor PCI-32765 (Ibrutinib) in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma with 17p Deletion