Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed Acute Myeloid Leukemia (AML)

Not Recruiting

Trial ID: NCT00766116

Purpose

This study will test an experimental combination of the drugs Mylotarg and 5-azacitidine in the hopes of finding a treatment that may be effective against Acute Myeloid Leukemia that has come back after treatment.

Official Title

A Phase I/II Trial of the Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed AML

Stanford Investigator(s)

Rondeep Brar
Rondeep Brar

Clinical Associate Professor, Medicine - Hematology

Lauren Maeda
Lauren Maeda

Clinical Associate Professor, Medicine - Oncology

Eligibility

Inclusion Criteria:

* Diagnosis of Relapsed AML
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2, and life expectancy \> 3 months
* ≥ 18 years old
* Previously untreated for current AML relapse
* Adequate organ function
* Written informed consent

Exclusion Criteria:

* Pregnant or breast-feeding women
* Growth factors that support platelet or white cell number or function must not have been administered within the past 7 days
* Currently receiving another investigational drug
* Currently receiving other anti-cancer agents
* Uncontrolled infection
* HIV positive
* Received previous therapy with either Mylotarg or 5-azacitidine

Intervention(s):

drug: Gemtuzumab ozogamicin

drug: 5-Azacitidine

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061

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