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

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NCT00304447

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Myelocytic Leukemia, Intravenous Infusions
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with CD33 positive, resistant or relapsed AML.

- Patients > 18 years of age.

- ECOG performance status 0-2.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Fever (>38), chills or hypotension (systolic BP therapy.

- Use of corticosteroids, diphenhydramine or acetaminophen within 24 hours of
enrollment.

- Participation in any other Mylotarg® protocol.

NCT00304447
Pfizer
Completed
Study Evaluating the Effect of Corticosteroids on Mylotarg® Infusion-Related Adverse Events in Patients With Leukemia

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Study Evaluating the Effect of Corticosteroids on Mylotarg® Infusion-Related Adverse Events in Patients With Leukemia
A Phase IV Study of Corticosteroids As Prophylaxis for Infusion-Related Adverse Events to Mylotarg® in Patients With Acute Myelogenous Leukemia (AML)
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Leukemia, Myelocytic, Acute
  • Infusions, Intravenous
Drug: Mylotarg
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2004
Not Provided

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00304447
0903X-100863
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
July 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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