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

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

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.

Study Overview

• Status: Terminated
• Conditions: AML
• Intervention / Treatment: Biological: AMLCTL

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • UCSD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Thomas A. Lane, MD
• Investigators: Principal Investigator: Thomas Lane, MD, UCSD

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: December 12, 2008
• First Submitted That Met QC Criteria: December 12, 2008
• First Posted (Estimate): December 15, 2008

Study Record Updates

• Last Update Posted (Actual): April 9, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: AML
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: 070768