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

Wyeth is now a wholly owned subsidiary of Pfizer30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Leukemia, Myelocytic, Acute Infusions, Intravenous

Interventions

MylotargDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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