Study Evaluating the Effect of Corticosteroids on Mylotar... | NCT00304447

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

NCT00304447

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Jul 29, 2009Estimated

Enrollment

Phase

Phase 4

Conditions

Leukemia, Myelocytic, Acute
Infusions, Intravenous

Interventions

Mylotarg

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2002

Primary Completion Date

Not provided

Completion Date

Jan 2004

First Submitted Date

Mar 15, 2006

First Submission Date that Met QC Criteria

Mar 15, 2006

First Posted Date

Mar 17, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2009

Last Update Posted Date

Jul 29, 2009Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Mylotarg	Drug

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015470	Leukemia, Myeloid, Acute
D007938	Leukemia

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000079982	Gemtuzumab

Ancestor Terms

ID	Term
D000080084	Calicheamicins
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided