drugset / Trial / NCT00283114

A Safety Study of Lintuzumab in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

NCT00283114

Phase 1 Completed 82 enrolled Seagen Inc.
NaSingle-groupOpen-labelTreatment

Summary

Phase 1a is an open-label, multi-dose, single-arm, dose-escalation study to define the toxicity profile, pharmacokinetics, and antitumor activity of SGN-33 in patients with myelodysplastic syndrome (MDS), acute myelogenous leukemia(AML), and CD33+ myeloproliferative diseases. Phase 1b includes patients with AML or MDS treated at the highest tolerated dose from phase 1a.

Timeline

Start
2005-11
Primary completion
2010-01
Completion
2010-01

Drugs

EvaluationDrugModalityDoseRoute
Subject lintuzumab Monoclonal antibody 1.5 mg/kg Intravenous
Subject lintuzumab Monoclonal antibody 8 mg/kg Intravenous