A Clinical Trial of Cytotoxic T Cells Augmenting Autologous Hematopoietic Stem Cell (AHSC) Transplantation for Acute Myeloid Leukemia (AML)

Inclusion Criteria (Initial Eligibility Screen):

Diagnosis of AML, not M3
At least 10% of circulating leukocytes are AML blast cells
Age 18 through 75
Sex male or female
Patient is considered a potential candidate for AHSCT

Exclusion criteria (Initial Eligibility Screen):

Participation in another immunotherapy trial within 30 days
Presence of active malignancy other than AML
History of autoimmune disease requiring systemic treatment
ECOG performance status of 3 or 4
Major organ system dysfunction
Recent (30 days) or current use of steroids other than topical skin preparations
History of allogeneic transplant
Patients who, for any reason are not deemed candidates for AHSCT

Eligibility for autologous CTL Infusion:

Inclusion Criteria:

Patient has CTL that are in sufficient number and are suitable for infusion
Patient is stable, afebrile, engrafted, ECOG status 0-2, in CR and received AHSCT 45 - 60 days earlier.

Exclusion or delay criteria:

Temperature > 38 C and/or known to be infected
Absence of engraftment ANC > 500 and Plt > 20,000 unsupported
Life expectancy less than 6 weeks
Autoimmune disease requiring systemic treatment.
ECOG performance status of 3 or 4
Major organ system dysfunction