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

This study has been completed.

First Received: May 17, 2002 Last Updated: August 20, 2009 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00037583

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 II

Study Type:	Interventional
Study Design:	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:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Gemtuzumab ozogamicin

U.S. FDA Resources

Further study details as provided by Wyeth:

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

Eligibility

Ages Eligible for Study:	18 Years to 59 Years
Genders Eligible for Study:	Both
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

No publications provided

Study ID Numbers:	0903B1-206
Study First Received:	May 17, 2002
Last Updated:	August 20, 2009
ClinicalTrials.gov Identifier:	NCT00037583 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Acute
Myeloid
Leukemia

Additional relevant MeSH terms:

Antibodies, Monoclonal
Leukemia
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Leukemia, Myeloid
Gemtuzumab
Leukemia, Myeloid, Acute
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2009