Conditions: Acute Myeloid Leukemia
Keywords: AML
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 50
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: 5-Azacitidine, Gemtuzumab ozogamicin

75 mg/m\^2 5-Aza 2 days then GO at 3 mg/m\^2 arm 2: 5-Azacitidine, Gemtuzumab ozogamicin

75mg/m\^2 5-Aza for 4 days then GO at 6 mg/m\^2 arm 3: 5-Azacitidine, Gemtuzumab ozogamicin

75 mg/m\^2 5-Aza for 6 days then GO at 6 mg/m\^2 arm 4: 5-Azacitidine, Gemtuzumab ozogamicin

75 mg/m\^2 5-Aza for 6 days then GO at 6 mg/m\^2

Interventions: intervention 1: 5-Azacitidine intervention 2: Gemtuzumab ozogamicin
Intervention descriptions: intervention 1: Given in cohorts of 3 starting with 2 doses of 5-azacitidine. The doses of 5-azacitidine will be escalated to 4 and then 6 doses if the dose escalation rules permit. intervention 2: Mylotarg given 2 times over 2 weeks

Protocol document: