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Study Evaluating the Safety and Efficacy of Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00037583
First Posted: May 20, 2002
Last Update Posted: August 21, 2009
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.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
May 17, 2002
May 20, 2002
August 21, 2009
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September 2003   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00037583 on ClinicalTrials.gov Archive Site
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Study Evaluating the Safety and Efficacy of Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia
A Dose-Ranging Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (go) Given in Combination With Cytarabine and Daunorubicin in Relapsed or Refractory Patients and in Younger de Novo Patients With Acute Myeloid Leukemia (AML)
The primary objectives are a) to establish the maximum tolerated dose (MTD) of gemtuzumab ozogamicin in combination with cytarabine and daunorubicin, and b) to assess the safety of gemtuzumab ozogamicin when given concurrently with cytarabine and daunorubicin.
Not Provided
Interventional
Phase 2
Primary Purpose: Treatment
Acute Myeloid Leukemia
Drug: Gemtuzumab Ozogamicin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
September 2003
September 2003   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • All adult patients with relapsed or refractory AML, as well as younger de novo AML patients are eligible for the study
  • Relapsed, refractory, and de novo AML patients are allowed in Phase I of this study
  • Phase II will only allow enrollment of younger de novo AML

Exclusion Criteria:

  • AML following an antecedent hematologic disorder (myelodysplasia or myeloproliferation) of greater than 2 months duration
  • De novo patients with M3 AML
  • AML secondary to exposure to chemotherapy or radiation
Sexes Eligible for Study: All
18 Years to 59 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00037583
0903B1-206
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Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
August 2009

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