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


Phase 4
18 Years
N/A
Not Enrolling
Both
Leukemia, Myelocytic, Acute, Infusions, Intravenous

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Wyeth is now a wholly owned subsidiary of Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

0903X-100863

NCT ID:

NCT00304447

Start Date:

April 2002

Completion Date:

January 2004

Related Keywords:

  • Leukemia, Myelocytic, Acute
  • Infusions, Intravenous
  • Leukemia
  • Mylotarg
  • Safety
  • Adverse Events
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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