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

• ClinicalTrials.gov Identifier: NCT00808080
• Recruitment Status: Terminated
• First Posted: December 15, 2008
• Results First Posted: February 22, 2016
• Last Update Posted: April 9, 2019
• Sponsor: Thomas A. Lane, MD
• Information provided by (Responsible Party): Thomas A. Lane, MD, University of California, San Diego

Study Description

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.

Condition or disease	Intervention/treatment	Phase
AML	Biological: AMLCTL	Phase 1; Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Clinical Trial of Cytotoxic T Cells Augmenting Autologous Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia
• Study Start Date: January 2010
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: June 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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. [ Time Frame: 2.5 years estimated ]

Secondary Outcome Measures :

1. 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. [ Time Frame: 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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, California

UCSD

La Jolla, California, United States, 92093

Sponsors and Collaborators

Thomas A. Lane, MD

Investigators

• Principal Investigator: Thomas Lane, MD; UCSD

More Information

• Responsible Party: Thomas A. Lane, MD, Professor of Pathology, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT00808080
• Other Study ID Numbers: 070768
• First Posted: December 15, 2008
• Results First Posted: February 22, 2016
• Last Update Posted: April 9, 2019
• Last Verified: April 2019

Keywords provided by Thomas A. Lane, MD, University of California, San Diego:

AML

Additional relevant MeSH terms:

Leukemia, Myeloid, Acute; Leukemia; Neoplasms by Histologic Type; Neoplasms; Leukemia, Myeloid