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

Leukemia, Myelocytic, Acute Clinical Trial

Official title:

A Phase IV Study of Corticosteroids As Prophylaxis for Infusion-Related Adverse Events to Mylotarg® in Patients With Acute Myelogenous Leukemia (AML)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00304447
• Other study ID #: 0903X-100863
• Status: Completed
• Phase: Phase 4
• First received: March 15, 2006
• Last updated: July 28, 2009
• Start date: April 2002
• Est. completion date: January 2004

Study information

• Verified date: July 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infusions, Intravenous
• Leukemia
• Leukemia, Myelocytic, Acute
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Mylotarg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of corticosteroids on the frequency and severity of Mylotarg® infusion-related adverse events.
Secondary	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.