NCT00528333

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

A Phase IIB, Randomized, Double-Blinded, Placebo-Controlled Study of Low Dose Cytarabine and Lintuzumab Compared to Low Dose Cytarabine and Placebo in Patients 60 Years of Age and Older With Previously Untreated AML

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Lintuzumab (SGN-33)	600 mg IV on days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent 28-day cycle up to a maximum of 12 cycles.
DRUG	Low dose cytarabine	20 mg SC twice a day on days 1-10 of each 28 day cycle up to a maximum of 12 cycles.
DRUG	Placebo	IV administration on days 1, 8, 15, and 22 of cycle 1 and days 1 and 15 of each subsequent 28-day cycle up to a maximum of 12 cycles

Timeline

• Start date: 2007-09-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2007-09-12
• Last updated: 2015-01-07

Locations

20 sites across 1 country: United States