Study Evaluating the Effect of Corticosteroids on Mylotarg® Infusion-Related Adverse Events in Patients With Leukemia - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00304447

Purpose

The purpose of this study is to evaluate the effect of corticosteroids on the frequency and severity of Mylotarg® infusion–related adverse events, to evaluate the effect of corticosteroids on the efficacy of Mylotarg® induced complete response (CR) and complete response with incomplete platelet recovery (CRp) at one-month post treatment.

Condition	Intervention	Phase
Leukemia, Myelocytic, Acute Infusions, Intravenous/Ae (Adverse Effects)	Drug: Mylotarg	Phase IV

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

Drug Information available for: Gemtuzumab ozogamicin Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase IV Study of Corticosteroids As Prophylaxis for Infusion-Related Adverse Events to Mylotarg® in Patients With Acute Myelogenous Leukemia (AML)

Further study details as provided by Wyeth:

Primary Outcome Measures:

The effect of corticosteroids on the frequency and severity of Mylotarg® infusion-related adverse events.

Secondary Outcome Measures:

The effect of corticosteroids on the efficacy of Mylotarg® induced complete response (CR) and complete response with incomplete platelets recovery (CRp) at one-month post treatment.

Estimated Enrollment:	30
Study Start Date:	April 2002
Estimated Study Completion Date:	January 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with CD33 positive, resistant or relapsed AML.
Patients > 18 years of age.
ECOG performance status 0-2.

Exclusion Criteria:

Fever (>38), chills or hypotension (systolic BP<105mmHg) in the 48 hours preceding therapy.
Use of corticosteroids, diphenhydramine or acetaminophen within 24 hours of enrollment.
Participation in any other Mylotarg® protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304447

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	0903X-100863
Study First Received:	March 15, 2006
Last Updated:	May 17, 2006
ClinicalTrials.gov Identifier:	NCT00304447
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Leukemia
Mylotarg
Safety
Adverse Events

Study placed in the following topic categories:

Leukemia
Acute myelogenous leukemia
Leukemia, Myeloid

Gemtuzumab
Leukemia, Myeloid, Acute
Acute myelocytic leukemia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009