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

NCT00304447

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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<105mmHg) in the 48 hours preceding
therapy.


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


- Participation in any other Mylotarg® protocol.

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Myelocytic Leukemia, Intravenous InfusionsStudy Evaluating the Effect of Corticosteroids on Mylotarg® Infusion-Related Adverse Events in Patients With Leukemia NCT00304447
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating the Effect of Corticosteroids on Mylotarg® Infusion-Related Adverse Events in Patients With Leukemia
Official Title  ICMJE A Phase IV Study of Corticosteroids As Prophylaxis for Infusion-Related Adverse Events to Mylotarg® in Patients With Acute Myelogenous Leukemia (AML)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Leukemia, Myelocytic, Acute
  • Infusions, Intravenous
Intervention  ICMJE Drug: Mylotarg
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: March 15, 2006)
30
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE January 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00304447
Other Study ID Numbers  ICMJE 0903X-100863
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP