Clinical Trials at Englewood Hospital: Chronic Lymphocytic Leukemia
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Chronic Lymphocytic Leukemia
EHMC IRB Study #: E-14-541
Dr. Francis Forte
National Cancer Institute - Alliance
A041202 - A Randomized Phase III Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients ( ≥ 65 Years of Age) with Chronic Lymphocytic Leukemia (CLL)
Patients must have a diagnosis of intermediate or high-risk CLL that meets the IWCLL criteria for treatment. Patients must not: have received prior therapy for CLL, be on anticoagulants, or have significant cardiac disease.
To determine whether progression free survival (PFS) is superior after therapy with bendamustine plus rituximab, ibrutinib alone, or ibrutinib plus rituximab in patients age 65 or older with previously untreated CLL.
Summary of procedures:
Eligible patients will be randomized 1:1:1 into one of three treatment arms: (1) Arm 1 consists of six 28-day cycles. For Cycle 1, rituximab is given as an IV infusion on Day 0. For Cycles 2 through 6, rituximab is given on Day 1. Bendamustine is given as an IV infusion on Days 1 and 2 of Cycles 1-6. (2) Arm 2 consists of ibrutinib taken orally on a daily basis until disease progression. (3) Arm 3 consists of ibrutinib taken daily plus rituximab given as an IV infusion weekly for four weeks starting on Cycle 2 Day 1 (Days 1, 8, 15, and 22), then on Day 1 only of Cycles 3 through 6. Ibrutinib will be continued daily past Cycle 6 and will be taken until disease progression. All subjects will be followed every 3 months until progression of disease and then will be followed every 6 months for survival. Subjects in Arm 1 are eligible to cross over to receive daily ibrutinib upon documentation of progression.
*Each listing only contains a summary of the study information. Please contact the Principal Investigator or Study Coordinator for the full details on a particular study.