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Study Evaluating Gemtuzumab Ozogamicin in Acute Myeloid Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00037596
First Posted: May 20, 2002
Last Update Posted: February 13, 2013
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 of gemtuzumab ozogamicin in combination with cytarabine and b) to assess the safety of gemtuzumab ozogamicin when given concurrently with cytarabine.

Condition Intervention Phase
Acute Myeloid Leukemia Drug: Gemtuzumab Ozogamicin Drug: cytarabine. 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 in Relapsed or Refractory Patients and Alder De Novo Patients With Acute Myeloid Leukemia.

Resource links provided by NLM:


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

Study Start Date: August 2000
Study Completion Date: April 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00037596


Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

ClinicalTrials.gov Identifier: NCT00037596     History of Changes
Other Study ID Numbers: 0903B1-205
First Submitted: May 17, 2002
First Posted: May 20, 2002
Last Update Posted: February 13, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Gemtuzumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs


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