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

Wyeth

Status and phase: Completed; Phase 4

Conditions: Infusions, Intravenous; Leukemia, Myelocytic, Acute

Treatments: Drug: Mylotarg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00304447

0903X-100863

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)