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

Phase 1

Terminated

• Conditions: AML
• Interventions: Biological: AMLCTL

• Registration Number: NCT00808080
• Lead Sponsor: Thomas A. Lane, MD

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2008-12-12
• Study First Submitted QC: 2008-12-12
• Study First Posted: 2008-12-15
• Study Start: 2010-01
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Results First Submitted: 2015-11-30
• Results First Submitted QC: 2016-01-25
• Results First Posted: 2016-02-22
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biologic	AMLCTL	AML_CTL cells

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.	2.5 years estimated	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.

Trial Locations

Locations (1)

UCSD; 🇺🇸 La Jolla, California, United States