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Study Evaluating Gemtuzumab Ozogamicin in Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00037596
First received: May 17, 2002
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00037596     History of Changes
Other Study ID Numbers: 0903B1-205
Study First Received: May 17, 2002
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013