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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
  Purpose
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.

Condition Intervention Phase
Acute Myeloid Leukemia Drug: Gemtuzumab Ozogamicin Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Enrollment: 69
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT00037583     History of Changes
Other Study ID Numbers: 0903B1-206
First Submitted: May 17, 2002
First Posted: May 20, 2002
Last Update Posted: August 21, 2009
Last Verified: August 2009

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Acute
Myeloid
Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Gemtuzumab
Antineoplastic Agents