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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00037583
First received: May 17, 2002
Last updated: August 20, 2009
Last verified: August 2009

May 17, 2002
August 20, 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
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*   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
Both
18 Years to 59 Years
No
Contact information is only displayed when the study is recruiting subjects
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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