A Study of Venetoclax in combination with Cobimetinib and Venetoclax in combination with Idasanutlin in Patients aged >=60 years with Relapsed or Refractory Acute Myeloid Leukemia who are not eligible...

Mise à jour : Il y a 4 ans
Référence : EUCTR2015-003386-28

A Study of Venetoclax in combination with Cobimetinib and Venetoclax in combination with Idasanutlin in Patients aged >=60 years with Relapsed or Refractory Acute Myeloid Leukemia who are not eligible for Cytotoxic Therapy

Femme et Homme

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Extrait

Phase IB: • To assess the safety and tolerability of venetoclax in combination with cobimetinib (Ven+Cob), and venetoclax in combination with idasanutlin (Ven +Ida) • To determine the maximum tolerated doses (MTDs) of Ven+Cob, and Ven +Ida • To determine the recommended Phase II dose (RP2D) of the Ven+Cob, and Ven+Ida Phase II: • To evaluate preliminary efficacy as measured by the proportion of complete remission (CR), complete remission with incomplete blood count recovery (CRi), and complete remission with incomplete platelet count recovery (CRp) with Ven+Cob, and Ven+Ida


Critère d'inclusion

  • Relapsed or refractory acute myeloid leukemia

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