A Randomized, Multicenter, Open-Label, 3 Arm Phase 3 Study of Obinutuzumab in Combination with Chlorambucil, ACP 196 in Combination with Obinutuzumab, and ACP-196 Monotherapy in Subjects with Previous...

Mise à jour : Il y a 4 ans
Référence : EUCTR2014-005582-73

A Randomized, Multicenter, Open-Label, 3 Arm Phase 3 Study of Obinutuzumab in Combination with Chlorambucil, ACP 196 in Combination with Obinutuzumab, and ACP-196 Monotherapy in Subjects with Previously Untreated Chronic Lymphocytic Leukemia

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Extrait

To evaluate the efficacy of obinutuzumab in combination with chlorambucil (Arm A) compared with acalabrutinib in combination with obinutuzumab (Arm B), based on IRC assessment of PFS per IWCLL 2008 criteria, in subjects with previously untreated CLL.


Critère d'inclusion

  • Untreated Chronic Lynphocytic Leukemia