A Study of the Efficacy of ABT-199 (GDC-0199) in Subjects with Relapsed or Refractory or previously untreated Chronic Lymphocytic Leukemia with the 17p Deletion

Mise à jour : Il y a 4 ans
Référence : EUCTR2012-004027-20

Femme et Homme

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Extrait

Main Cohort Primary Objective: To evaluate the efficacy of venetoclax monotherapy in subjects with relapsed or refractory chronic lymphocytic leukemia (CLL) harboring the 17p deletion. Efficacy will be measured by overall response rate (ORR). Safety Expansion Cohort Primary Objectives: A safety expansion cohort is being added with the primary objective of evaluating the safety of ABT-199 in approximately 50 subjects with relapsed or refractory CLL harboring 17p deletion per the updated TLS prophylaxis and management measures.


Critère d'inclusion

  • Chronic Lymphocytic Leukemia 17 p Deletion