Fractionated Gemtuzumab Ozogamicin Followed by Non-engraftment Donor Leukocyte Infusions for Relapsed/Refractory Acute Myeloid Leukemia

Inclusion Criteria:

- Histologic confirmation of acute myeloid leukemia (AML)

- Recurrence or progression (including refractory disease) of AML after at least 1 prior
standard treatment with progression within 6 months from last treatment.

- No curative treatment option is available

-> 4-weeks since prior chemotherapy or radiation to cellular therapy infusion.

- Age equal to or greater than 18 years.

- Patients with a history of invasive second malignancy who are disease free for > 2
years.

- Patients must have an expected life expectancy of at least 2 months at the time of
initiation of treatment

- No active systemic infections allowed.

- Patients who have relapsed after standard autologous stem cell infusion are eligible
as long as they meet all inclusion criteria and no exclusion criteria. These patients
must be out more than 6 months from cell infusion to be eligible for enrollment.

- DLCO > 40% with no symptomatic pulmonary disease.

- LVEF > 40% by MUGA or echocardiogram.

- Creatinine <1.5x ULN or any serum creatinine level associated with a measured or
calculated creatinine clearance of >40 mL/min, AST and ALT < 2.5x ULN, Total Bilirubin
< 2 x ULN

- Women of childbearing potential and sexually active males must use 2 forms of
effective contraception method from time of consent through 6 months after completing
treatment (whether last treatment is infusion or drug).

- Not pregnant or nursing. Women of child bearing potential must have a negative serum
or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG)
within 7 days prior to beginning of treatment (drug). Post-menopausal women (surgical
menopause or lack of menses >12 months) do not need to have a pregnancy test, please
document status.

- Performance status < 2 (or KPS 70)

Exclusion Criteria:

- Evidence of HIV infection.

- Any uncontrolled severe, concurrent illness which in the opinion of the treating
physician would make this protocol treatment unreasonably hazardous for the patient.

- Oxygen dependent obstructive pulmonary disease.

- Failure to demonstrate adequate compliance with medical therapy and follow-up

- Significant medical or psychiatric illness that would impair the ability to
participate in protocol therapy.

- Previous allogeneic stem cell transplant

- Patients who have had previous purine analog (fludarabine, pentostatin, 2-CDA)
treatment or treatment with alemtuzumab within 1 year of entering the study

- Previous history of Veno-occlusive disease/Sinusoidal Obstruction Syndrome

- Active hepatitis B or C

- Patients with known active central nervous system leukemia

- Patients with prior treatment of Gemtuzumab ozogamicin