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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

September 10, 2007
June 18, 2013
September 2007
August 2010   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: Patients will be on study up to approximately 2 years. ]
Complete list of historical versions of study NCT00528333 on ClinicalTrials.gov Archive Site
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 ]
Pharmacokinetic profile, Immunogenicity, Complete blood counts (CBC), Transfusion Requirements, Infections or Fevers of Unknown Origin Requiring Hospitalization or Intravenous (IV) Antibiotics, Quality of Life (QOL) assessments
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Acute Myeloid Leukemia
  • 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
  • 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
  • Experimental: 1
    Lintuzumab plus low dose cytarabine
    Interventions:
    • Drug: Lintuzumab (SGN-33)
    • Drug: Low dose cytarabine
  • Active Comparator: 2
    Placebo plus low dose cytarabine
    Interventions:
    • Drug: Low dose cytarabine
    • Drug: Placebo
Sekeres MA, Lancet JE, Wood BL, Grove LE, Sandalic L, Sievers EL, Jurcic JG. Randomized, phase IIb study of low-dose cytarabine and lintuzumab versus low-dose cytarabine and placebo in older adults with untreated acute myeloid leukemia. Haematologica. 2013 Jan;98(1):119-28. doi: 10.3324/haematol.2012.066613. Epub 2012 Jul 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
211
August 2010
August 2010   (final data collection date for primary outcome measure)

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).
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00528333
SG033-0003
Yes
Seattle Genetics, Inc.
Seattle Genetics, Inc.
Not Provided
Study Director: Eric Sievers, MD Seattle Genetics, Inc.
Seattle Genetics, Inc.
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP