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A phase I trial of BNC105P and ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia
A phase I trial of BNC105P and ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia
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A phase I trial of BNC105P and ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia
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A phase I trial of BNC105P and ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia
A phase I trial of BNC105P and ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia

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A phase I trial of BNC105P and ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia
A phase I trial of BNC105P and ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia
Journal Article

A phase I trial of BNC105P and ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia

2022
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Overview
Targeted therapies such as the Bruton's tyrosine kinase (BTK) inhibitor ibrutinib are better tolerated and have become standard of care for CLL. TABLE 1 Patient demographics and outcomes Patient demographic All cohorts n = 6 Cohort 1 (8 mg/m2) n = 3 Cohort 2 (12 mg/m2) n = 3 a Sex Male 5 2 3 Female 1 1 0 Age Median (range) 72 (52–75) 71 (52–75) 73 (60–75) <65 y 2 1 1 ≥65 y 4 2 2 BMI Median (range) 31.0 (21.2–38.2) 26.5 (21.2–32.9) 32.1 (29.9–38.2) Race White 6 (100%) 3 (100%) 3 (100%) Ethnicity Other (non-Hispanic/Latino) 6 (100%) 3 (100%) 3 (100%) ECOG score 0 1 (16.7%) 1 (33.3%) 0 (0%) 1 5 (83.3%) 2 (66.7%) 3 (100%) Years since diagnosis Median (range) 9.5 (8–12) 9 (8–12) 10 (9–10) Prior therapies Median (range) 2.5 (1–8) 2 (1–8) 3 (2–3) Prior ibrutinib 2 1 1 Patient outcomes # Cycles completed Median (range) 4.9 (1.7–6) 4.5 (2–5.3) 6 (1.7–6) # Days on study Median (range) 128 (49–178) 104 (100–154) 152 (49–178) Adverse events Median (range) 6 (2–12) 6 (6–12) 8 (2–12) Serious adverse events Total 2 1 b 1 a, c Dose limiting toxicity Total 1 0 1 Best response achieved d PR 1 a 0 1 SD 3 2 1 NE 2 1 1 a One patient initially received BNC105P 12 mg/m2 monotherapy in cycle 1 and ibrutinib 420 mg monotherapy in cycle 2 (days 1–7) but because of a 25%–50% drop in platelets from baseline (from Gr1 →Gr2) was dose reduced to 8 mg/m2 BNC105P and ibrutinib 280 mg daily (as proscribed in the protocol but not a defining DLT) and subsequently tolerated this dose for six cycles with a partial remission. b This SAE was a patient who developed cryptococcal pneumonia following heavy self-exposure to bat droppings (guano) while cleaning an attic. The SAE occurred on study cycle 3 day 7, which was outside the defined DLT time window for the study. c This SAE was sudden death (of unknown cause; no autopsy) of the patient described in footnote a who completed six cycles of 8 mg/m2 BNC105P + Ibrutinib 280 mg daily and was off combination study treatment and being treated only with ibrutinib monotherapy when the SAE occurred. d BMI, body mass index; ECOG, Eastern Cooperative Group; NE, not evaluable; PR, partial remission; SD, stable disease. Two SAEs occurred: one sudden death (unknown cause) occurred 10 days after completing study combination treatment while receiving ibrutinib monotherapy; one patient in cohort 1 developed cryptococcal pneumonia on C3D7 following heavy exposure to bat droppings (guano) at a timepoint beyond the defined DLT time window.