Home
Clinical Trials
Study Evaluating the Effect o...

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

Last Updated: 2009-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2004-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Nonmyeloablative Preparative Regimen Using Mylotarg for Patients With High Risk Acute Myeloid Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Chronic Myeloid Leukemia (CML) and Myelodysplastic Syndrome (MDS)

NCT00038805

Leukemia

TERMINATED PHASE2/PHASE3

A Study Of Treatment Patterns And Clinical Outcomes In Patients Diagnosed With Acute Myeloid Leukemia Who Received Mylotarg in the Real-World

NCT04337138

Leukemia, Myeloid, Acute

COMPLETED

Study Evaluating Mylotarg (Gemtuzumab Ozogamicin) in Usual Care

NCT00161668

Acute Myeloid Leukemia

COMPLETED

Study Evaluating Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia After Stem Cell Transplant

NCT00044733

Acute Myelogenous Leukemia

COMPLETED PHASE2

Mylotarg and Ara-C in Untreated Patients Above 60 Years With AML and High-Risk MDS

NCT00195000

Acute Myeloid Leukemia Myelodysplastic Syndrome

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Leukemia, Myelocytic, Acute Infusions, Intravenous

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mylotarg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers