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

This study is ongoing, but not recruiting participants.

Sponsored by:	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

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

Drug Information available for: Cytarabine Cytarabine hydrochloride Daunorubicin hydrochloride Daunorubicin Gemtuzumab ozogamicin

U.S. FDA Resources

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)

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

Study ID Numbers:	0903B1-206
Study First Received:	May 17, 2002
Last Updated:	May 18, 2006
ClinicalTrials.gov Identifier:	NCT00037583
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Acute
Myeloid
Leukemia

Study placed in the following topic categories:

Antibodies, Monoclonal
Daunorubicin
Leukemia
Antibodies
Acute myelogenous leukemia
Leukemia, Myeloid

Gemtuzumab
Leukemia, Myeloid, Acute
Acute myelocytic leukemia
Cytarabine
Immunoglobulins

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009