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

Tracking Information
First Received Date ^ICMJE	May 17, 2002
Last Updated Date	August 20, 2009
Start Date ^ICMJE
Primary Completion Date	September 2003 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00037583 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study Evaluating the Safety and Efficacy of Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia
Official Title ^ICMJE	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)
Brief Summary	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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment
Condition ^ICMJE	Acute Myeloid Leukemia
Intervention ^ICMJE	Drug: Gemtuzumab Ozogamicin
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	69
Completion Date	September 2003
Primary Completion Date	September 2003 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 59 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00037583
Responsible Party
Study ID Numbers ^ICMJE	0903B1-206
Study Sponsor ^ICMJE	Wyeth
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Wyeth
Verification Date	August 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP