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

Phase 1/Phase 2
18 Years
90 Years
Open (Enrolling)
Acute Myeloid Leukemia

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Trial Information

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

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.

Inclusion Criteria:

- Diagnosis of Relapsed AML

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

In Phase I the Maximum Tolerated Dose will be the maximum dose at which fewer than one-third of patients experience Dose Limiting Toxicity

Outcome Time Frame:

approximately 4 years

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

July 2005

Completion Date:

May 2014

Related Keywords:

  • Acute Myeloid Leukemia
  • AML
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



Stanford University Stanford, California  94305
Northside Hospital/BMTGA Atlanta, Georgia  30342