The purpose of this study is to evaluate the impact of sequential overlapping treatment with PD-1 monoclonal antibody (mAb), pembrolizumab/MK-1375, followed by ibrutinib on endogenous immune function in previously untreated, high-risk CLL patients. Immune function will be evaluated through various laboratory correlative tests.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Pembrolizumab will be administered intravenously (IV) at 200 mg every 3 weeks for 1 year and up to 2 years.
Ibrutinib will be administered orally once daily at approximately the same time each day at the dose of 420 mg daily (3 capsules of 140 mg daily).
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Overall Response Rate (ORR) to the Therapeutic Intervention
Response categories according to The International Workshop on Chronic Lymphocytic Leukemia (IWCLL): Complete remission (CR); Complete remission with incomplete marrow recovery (CRi); Partial remission (PR); Progressive disease (PD); Stable disease (SD), defined as not meeting criteria for CR, CRi, PR or PD.
Time frame: Up to 2 years
Time to Best Response
Time to best response to chronic lymphocytic leukemia (CLL) to the therapeutic intervention.
Time frame: Up to 2 years
Progression-free Survival (PFS)
Progressive disease (PD), defined as ≥ 50% rise in lymphocyte count to \> 5 x10\^9/L, ≥ 50% increase in lymphadenopathy, ≥ 50% increase in liver or spleen size, Richter's transformation, or new cytopenias due to CLL.
Time frame: Up to 2 years
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