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Protocol Summary


Protocol No.
PSCI-19-005
Prinicipal Investigator
Claxton, David
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
EA9161
Title
EA9161: A Randomized Phase III Study of the Addition of Venetoclax to Ibrutinib and Obinutuzumab versus Ibrutinib and Obinutuzumab in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)
Objective
PRIMARY OBJECTIVES:
I. To compare the progression free survival (PFS) of the time limited administration of the three-drug combination ibrutinib-obinutuzumab-venetoclax (IOV) to ibrutinib-obinutuzumab (IO) in untreated chronic lymphocytic leukemia (CLL) patients younger than 70 years of age.

SECONDARY OBJECTIVES:
I. Evaluate overall survival (OS) of patients based on treatment arm. II. Monitor and assess toxicity of treatment based on treatment arm.
Applicable Disease Sites
Lymphoid Leukemia
Drugs Involved
IBRUTINIB

OBINUTUZUMAB

VENETOCLAX
Status
Open
Participating Institutions
Hershey Medical Center