A Study of Lintuzumab (SGN-33) in Combination With Low Dose Cytarabine in Patients 60+ Years With AML

Phase 2 Completed 211 enrolled Seagen Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to assess whether there is a survival benefit with lintuzumab given in combination with low dose cytarabine versus low dose cytarabine and placebo in patients with AML.

Timeline

Start: 2007-09
Primary completion: 2010-08
Completion: 2010-08

Outcome

Missed primary endpoint

paper Survival was not significantly prolonged with lintuzumab treatment PMID 22801961 ↗

paper hazard ratio 0.96; 95% confidence interval (CI) 0.72-1.28; P=0.7585 PMID 22801961 ↗

Publications

Results Sekeres MA, Lancet JE, Wood BL, Grove LE, Sandalic L, Sievers EL, Jurcic JG. Randomized phase IIb study of low-dose cytarabine and lintuzumab versus low-dose cytarabine and placebo in older adults with untreated acute myeloid leukemia. Haematologica. 2013 Jan;98(1):119-28. doi: 10.3324/haematol.2012.066613. Epub 2012 Jul 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	lintuzumab	Monoclonal antibody	600 mg	Intravenous
Background	Cytarabine	Small molecule	20 mg	Subcutaneous