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

December 17, 2014 updated by: Seagen Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

211

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Southern Cancer Center
    • California
      • Beverly Hills, California, United States, 90210
        • Tower Cancer Research Foundation
      • Glendale, California, United States, 91204
        • Glendale Memorial Hospital
      • Los Angeles, California, United States, 90057
        • Kenmar Research Institute
      • Los Angeles, California, United States, 90095-1678
        • University of California Los Angeles
      • Pleasant Hill, California, United States, 94523
        • Bay Area Cancer Research Group
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
    • Florida
      • Lakeland, Florida, United States, 33805
        • Lakeland Regional Cancer Center
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center & Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology-Hematology Associates
    • Michigan
      • Lansing, Michigan, United States, 48910
        • Michigan State University, Breslin Cancer Center
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic Cancer Research
    • New York
      • Lake Success, New York, United States, 11042
        • Northshore University Hospital, Monter Cancer Center
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Western Pennsylvania Cancer Institute
    • South Carolina
      • Greenville, South Carolina, United States, 29601
        • Cancer Centers of the Carolinas
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas, MD Anderson Cancer Center
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Gunderson Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Untreated AML that occurred de novo, after prior exposure to chemotherapy for a separate malignancy, or evolved from an antecedent hematologic disorder.
  • After being informed of the potential benefits and risks of available treatment options, patients must have declined intensive chemotherapy for AML.
  • At least 20% blasts in blood or marrow.
  • Must have a minimum of 50% leukemic blasts that express CD33.
  • ECOG performance status score of 0 to 2.
  • WBC less than 30,000/µL

Exclusion Criteria:

  • No known diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia.
  • No other active systemic malignancies treated with chemotherapy within the last 12 months.
  • Must not have received previous chemotherapy (except hydroxyurea) for AML.
  • Must not have significantly abnormal kidney or liver disease.
  • Must not have known human immunodeficiency virus (HIV).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Lintuzumab plus low dose cytarabine
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.
Other Names:
  • SGN-33
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.
Other Names:
  • Ara-C, Cytosar
Active Comparator: 2
Placebo plus low dose cytarabine
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.
Other Names:
  • Ara-C, Cytosar
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Complete blood counts (CBC), Transfusion Requirements, Infections or Fevers of Unknown Origin Requiring Hospitalization or IV Antibiotics
Time Frame: 13 months
13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Investigators

  • Study Director: Eric Sievers, MD, Seagen Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

September 10, 2007

First Submitted That Met QC Criteria

September 11, 2007

First Posted (Estimate)

September 12, 2007

Study Record Updates

Last Update Posted (Estimate)

January 7, 2015

Last Update Submitted That Met QC Criteria

December 17, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SG033-0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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