Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Titre officiel

An Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib Versus Chlorambucil)

Sommaire:

Étude de prolongation ouverte chez les patients de 65 ans ou plus atteints de leucémie lymphoïde chronique (LLC) ou d’un petit lymphome lymphocytaire et qui ont participé à l’étude PCYC-1115-CA (PCI-32765 par rapport au chlorambucil).

Description de l'essai

Primary Outcome:

• Progression-free Survival (PFS)
• Safety as measured by all AEs and SAEs for patients randomized to Arm B (Ibrutinib) in Study PCYC-1115-CA
• Long-term follow-up and Second-line therapy monitoring
• Efficacy evaluation of subsequent therapy

Voir cet essai sur ClinicalTrials.gov