lack of accrual

The aim of this protocol is to investigate a novel form of immune therapy for patients with acute myelogenous leukemia (AML) who are in remission (CR) but who are at high risk for relapse.

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

No adverse events or serious adverse events occurred related to study treatment as no patients have received their AML CTL infusion.

Accrual trial was insufficient. No patient became eligible for CTL infusion. Cell culture information gleaned from a comparison of different culture methods will greatly facilitate future studies of autologous CTL-directed immunotherapy for AML.