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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Clinical Trial of Cytotoxic T Cells Augmenting Autologous Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia

Conditions
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AML

Intervention / Treatment
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* Biological: AMLCTL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biologic<br>AML_CTL cells | Biological: AMLCTL<br>* Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 Dose Cohorts for Safety Monitoring. Each Cohort is Assessed for DLT for One Month After Autologous Cultured CTL Infusion Prior to Enrolling the Next Cohort. |  | 2.5 years estimated | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| If Phase I Has Successfully Shown the Target Dose to be Below the MTD Continue Enrolling Until 38 Patients Have Received the Target Dose. Patients Will be Monitored for Safety and Efficacy. | 6 patients were enrolled, however none of the 6 patients became eligible to receive the AML CTL Infusion. No CTL infusions were administered to any subject, consequently NO outcome measure results are available. | 2.5 years estimated | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AML