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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00528333
First received: September 10, 2007
Last updated: June 18, 2013
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Acute Myeloid Leukemia
Drug: Lintuzumab (SGN-33)
Drug: Low dose cytarabine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete blood counts (CBC), Transfusion Requirements, Infections or Fevers of Unknown Origin Requiring Hospitalization or IV Antibiotics [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]

Enrollment: 211
Study Start Date: September 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528333

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

Publications:
Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT00528333     History of Changes
Other Study ID Numbers: SG033-0003
Study First Received: September 10, 2007
Last Updated: June 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:
Lintuzumab
Antigens, CD33
Antibodies, Monoclonal
Leukemia, Myeloid, Acute
Hematologic Diseases
Leukemia

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014