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

Primary Purpose

Leukemia, Myelocytic, Acute, Infusions, Intravenous

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Mylotarg

About this trial

This is an interventional treatment trial for Leukemia, Myelocytic, Acute focused on measuring Leukemia, Mylotarg, Safety, Adverse Events

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00304447

First Posted

March 15, 2006

Last Updated

July 28, 2009

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00304447

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Completed

Study Start Date

April 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia, Myelocytic, Acute, Infusions, Intravenous

Keywords

Leukemia, Mylotarg, Safety, Adverse Events

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Mylotarg

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Wyeth is now a wholly owned subsidiary of Pfizer

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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