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

Primary Aim: To conduct a Phase 1/2 clinical trial of autologous CTL-mediated immunotherapy
in a homogeneous group of patients with AML who have recently received an autologous
hematopoietic stem cell transplant. Specifically:

Phase 1: To determine the MTD of autologous AML-reactive cultured CTL in patients with AML
who have recently received an AHSCT.

Phase 2: To determine 1 year progression-free survival of the study group vs institutional
historical control group composed of a sequential series of recent patients who have
received an AHSCT for 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