Summary

for people ages 18-90 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:
Edward D Ball

Description

Summary

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

Details

In the Phase I portion of the study patients with a diagnosis of AML who have relapsed disease will be treated with an assigned number of doses of 5 azacitidine followed by Mylotarg administered two times over two weeks

In the Phase II portion of the study patients will be treated with the dose of 5azacitidine determined to be safe in the Phase I portion of the study followed by Mylotarg.

A sample of blood or bone marrow will be obtained prior to initiation of treatment and another sample obtained after treatment with 5-azacitidine but before Mylotarg and the samples will be tested in the laboratory to determine response to treatment.

Keywords

Acute Myeloid Leukemia AML Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Azacitidine Gemtuzumab 5-Azacitidine Gemtuzumab ozogamicin

Eligibility

You can join if…

Open to people ages 18-90

  • 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

You CAN'T join if...

  • 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

Locations

  • UCSD Moores Cancer Center
    La Jolla California 92093 United States
  • Stanford University
    Stanford California 94305 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT00766116
Phase
Phase 1/2
Lead Scientist
Edward D Ball
Study Type
Interventional
Last Updated
August 2017