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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00528333
Recruitment Status : Completed
First Posted : September 12, 2007
Last Update Posted : January 7, 2015
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Tracking Information
First Submitted Date  ICMJE September 10, 2007
First Posted Date  ICMJE September 12, 2007
Last Update Posted Date January 7, 2015
Study Start Date  ICMJE September 2007
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2008)
Overall survival [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2007)
Overall survival [ Time Frame: Patients will be on study up to approximately 2 years. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2008)
Complete blood counts (CBC), Transfusion Requirements, Infections or Fevers of Unknown Origin Requiring Hospitalization or IV Antibiotics [ Time Frame: 13 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2007)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Lintuzumab (SGN-33) in Combination With Low Dose Cytarabine in Patients 60+ Years With AML
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukemia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 20, 2010)
211
Original Estimated Enrollment  ICMJE
 (submitted: September 11, 2007)
210
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00528333
Other Study ID Numbers  ICMJE SG033-0003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seattle Genetics, Inc.
Study Sponsor  ICMJE Seattle Genetics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Eric Sievers, MD Seattle Genetics, Inc.
PRS Account Seattle Genetics, Inc.
Verification Date December 2014

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