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- W2034741760 abstract "S380 Context: Lintuzumab, a humanized anti-CD33 antibody, has modest activity against AML. To increase the antibody's potency yet avoid nonspecific cytotoxicity seen with b-emitting isotopes, Ac (t1/2 1⁄410 days), which yields 4 a-emitting isotopes, was conjugated to lintuzumab. Objectives: We sought to determine the MTD, toxicity, pharmacokinetics, and antileukemic activity of Ac-lintuzumab. Design: We conducted a first-in-man, phase I, 3+3, dose-escalation trial from 2006-2012. Setting: This was a single-institution study performed at a tertiary cancer center. Patients: Eighteen patients (median age, 64 yrs; range, 45-80 yrs) with relapsed (n1⁄411) or refractory (n1⁄47) AML were treated. Intervention: Patients received a single infusion of Ac-lintuzumabat doses of 0.5 (n1⁄43), 1 (n1⁄44), 2 (n1⁄43), 3 (n1⁄46) or 4 (n1⁄42) mCi/kg. Main Outcome Measure: MTD was defined as the highest dose for which the incidence of DLT was 35 days in 1 patient receiving 4 mCi/kg and death from sepsis in 2 patients receiving 3 and 4 mCi/kg. The MTD was 3 mCi/kg. Myelosuppression was the most common toxicity. Median time to resolution of grade 4 leukopenia was 27 days (range, 0-71 days). Significant extramedullary toxicities were limited to transient grade 3 liver function abnormalities in 3 patients. We analyzed plasma pharmacokinetics by gamma counting at energy windows for 2 daughters of Ac, francium-221 and bismuth-213. Two-phase elimination kinetics were seen with mean plasma t1/2 -a and t1/2 -b of 1.9 and 38 hours, respectively, similar to other lintuzumab constructs containing long-lived radionuclides. Peripheral blasts were eliminated in 10 of 16 evaluable patients (63%), but only at doses of 1 mCi/kg. Marrow blast reductions were seen in 10 of 15 evaluable patients (67%) at 4 weeks, including 8 patients (53%) who had blast reductions of 50%. Three patients receiving 1, 3, and 4 mCi/kg achieved marrow blasts of 5%. Conclusions: This is the first study to show that therapy with a targeted a-particle generator is feasible in humans. Ac-lintuzumab had antileukemic activity across all dose levels and is now being investigated in a multicenter phase I/II trial in combination with low-dose cytarabine for older AML patients." @default.
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- W2034741760 date "2013-09-01" @default.
- W2034741760 modified "2023-09-27" @default.
- W2034741760 title "A Phase I Trial of Lenalidomide in Combination with Intermediate Dose Cytarabine (IDC) in Relapsed or Refractory Acute Myeloid Leukemia (AML) Patients" @default.
- W2034741760 doi "https://doi.org/10.1016/j.clml.2013.07.089" @default.
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