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Study Evaluating Gemtuzumab O...

Study Evaluating Gemtuzumab Ozogamicin in Acute Myeloid Leukemia

Last Updated: 2013-02-13

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2003-04-30

Brief Summary

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The primary objectives are a) to establish the maximum tolerated dose of gemtuzumab ozogamicin in combination with cytarabine and b) to assess the safety of gemtuzumab ozogamicin when given concurrently with cytarabine.

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Detailed Description

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Conditions

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Acute Myeloid Leukemia

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Gemtuzumab Ozogamicin

Intervention Type DRUG

cytarabine.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Morphologic diagnosis of AML from bone marrow aspirate and biopsy
* Flow cytometry, performed at the study site, must demonstrate that the patient has AML that is CD33+, based on local laboratory criteria
* Age 18 years or older for relapsed or refractory patients for Phase I of this study

Exclusion Criteria

* Patients with de novo AML of the M3 subtype
* AML following an antecedent hematologic disorder (myelodysplasia or myeloproliferation) of \> 2 months duration
* AML secondary to exposure to chemotherapy or radiation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers