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Completed

NCT Number: NCT00304447

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

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.

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Key information

Conditions

Leukemia, Myelocytic, Acute Hematologic Diseases Hemic and Lymphatic Diseases Infusions, Intravenous Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mylotarg

Drug

Primary outcomes

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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2004
First posted
Mar 17, 2006
Registry last updated
Jul 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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