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

NCT00528333 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2015-01-07

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Seagen Inc.

    lead INDUSTRY

Principal Investigators

  • Eric Sievers, MD · Seagen Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00528333 on ClinicalTrials.gov