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Study Evaluating Gemtuzumab Ozogamicin in Acute Myeloid Leukemia

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NCT00037596

Last updated on May 12, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Myeloid Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Morphologic diagnosis of AML from bone marrow aspirate and biopsy

- Flow cytometry, performed at the study site, must demonstrate that the patient has AML
that is CD33+, based on local laboratory criteria

- Age 18 years or older for relapsed or refractory patients for Phase I of this study

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients with de novo AML of the M3 subtype

- AML following an antecedent hematologic disorder (myelodysplasia or
myeloproliferation) of > 2 months duration

- AML secondary to exposure to chemotherapy or radiation

NCT00037596
Pfizer
Completed
Study Evaluating Gemtuzumab Ozogamicin in Acute Myeloid Leukemia

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Pfizer Clinical Trials Contact Center

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[email protected]

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Study Evaluating Gemtuzumab Ozogamicin in Acute Myeloid Leukemia
A Dose Ranging Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) Given in Combination With Cytarabine in Relapsed or Refractory Patients and Alder De Novo Patients With Acute Myeloid Leukemia.
The primary objectives are a) to establish the maximum tolerated dose of gemtuzumab ozogamicin in combination with cytarabine and b) to assess the safety of gemtuzumab ozogamicin when given concurrently with cytarabine.
Not Provided
Interventional
Phase 2
Primary Purpose: Treatment
Acute Myeloid Leukemia
  • Drug: Gemtuzumab Ozogamicin
  • Drug: cytarabine.
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
Not Provided
April 2003
April 2003   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Morphologic diagnosis of AML from bone marrow aspirate and biopsy
  • Flow cytometry, performed at the study site, must demonstrate that the patient has AML that is CD33+, based on local laboratory criteria
  • Age 18 years or older for relapsed or refractory patients for Phase I of this study

Exclusion Criteria:

  • Patients with de novo AML of the M3 subtype
  • AML following an antecedent hematologic disorder (myelodysplasia or myeloproliferation) of > 2 months duration
  • AML secondary to exposure to chemotherapy or radiation
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00037596
0903B1-205
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
February 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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