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Phase I trial of alpha-particle immunotherapy with 225Ac-lintuzumab and low-dose cytarabine in patients age 60 or older with untreated acute myeloid leukemia.

456Objectives: 225Ac-lintuzumab is a radioimmunoconjugate composed of 225Ac, which emits 4 α-particles, linked to a humanized anti-CD33 monoclonal antibody. An initial phase I trial showed that a single infusion of 225Ac-lintuzumab is safe at doses ≤ 111 kBq/kg and has activity in relapsed/refractory acute myeloid leukemia (AML). We conducted a multicenter, phase I dose-escalation trial to determine the maximum tolerated dose (MTD), toxicity, and biological activity of fractionated-dose 225Ac-lintuzumab in combination with low-dose cytarabine (LDAC).Methods: Patients 蠅 60 years with untreated AML not candidates for intensive chemotherapy were eligible. Patients received LDAC 20 mg twice daily for 10 days every 4-6 weeks for up to 12 cycles. During Cycle 1, 2 fractions of 225Ac-lintuzumab were given 1 week apart, beginning 4-7 days following completion of LDAC. To prevent radiation-induced nephrotoxicity, patients were given furosemide while receiving 225Ac-lintuzumab then spironolactone for 1 year afterward. Four dose levels of 225Ac-lintuzumab were studied using a 3+3 design.Results: Eighteen patients (median age, 77 years; range, 68-87) completed therapy. Twelve (67%) had prior myelodysplastic syndrome (MDS), for which 10 (83%) received therapy with hypomethylating agents (n=9) or allogeneic hematopoietic cell transplantation (n=1). Eleven patients (61%) had intermediate-risk and 7 (39%) had poor-risk AML. Median CD33 expression was 81% (range, 30-100%). 225Ac...
Source: Journal of Nuclear Medicine - Category: Nuclear Medicine Authors: Tags: Radiopharmaceutical Therapy- Radioimmunotherapy and Radioembolization Source Type: research

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