Safety and efficacy
lung infections, diarrhea, toxicity, AML, infections, proctitis, skin infection, hepatic infection, gastrointestinal of grades 1-2, sepsis, ileus
INFECTIOUS ENTEROCOLITIS, LUNG INFECTION, INFECTIONS, AML, PROCTITIS, SKIN INFECTION, ADVERSE EVENT, HEPATIC INFECTION, SEPSIS, SALIVARY GLAND INFECTION, ILEUS
Three patients were treated at dose level 0 (19%), while 6 (37%) and 7 (44%) patients were treated at “triplet” dose levels 1 and 2, respectively. Dose level 2 was considered the maximum tolerated dose (MTD). All patients experienced at least one treatment-emergent adverse event (AE); one patient experienced an attributable grade ≥ 3 AE of diarrhea at dose level 2 which was considered a dose-limiting toxicity. Most of the attributable AE were gastrointestinal of grades 1-2. Additional gastrointestinal AE included grade 3 infectious enterocolitis in 4 patients (25%) and grade 3 proctitis and ileus in one patient each. Of the non-attributable AE, the most common were infections: 10 patients (63%) had lung infections (all grade 3), 6 patients (38%) had sepsis (5 grade 3 and 1 grade 4) and one patient each experienced grade 3 salivary gland infection, skin infection and hepatic infection (Supplemental Table Patients received a median of 1 cycle (range, 1–4) in the study. Five patients (31%) received >1 cycle of therapy and two patients (12.5%), both R/R AML, achieved an overall response [both attained CR with incomplete hematologic recovery (CRh); 1 each at dose level 1 and 2] after failure of a prior venetoclax containing regimen. Both patients attained MRD negative status by flow cytometry (at 1 in 10