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

This study is currently recruiting participants.
Verified April 2012 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Thomas A. Lane, MD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00808080
First received: December 12, 2008
Last updated: April 18, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
AML
 Biological: AMLCTL
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Trial of Cytotoxic T Cells Augmenting Autologous Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: January 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: AMLCTL
    Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808080

Contacts
Contact: Thomas Lane, MD 858-822-6600 tlane@ucsd.edu
Contact: Sue Corringham, RN 858-822-6387 scorringham@ucsd.edu

Locations
United States, California
UCSD Recruiting
LA Jolla, California, United States, 92093
Contact: Thomas Lane, MD     858-822-6600     tlane@ucsd.edu    
Contact: Sue Corringham, RN     858-822-6387     scorringham@ucsd.edu    
Principal Investigator: Thomas Lane, MD            
Sponsors and Collaborators
Thomas A. Lane, MD
Investigators
Principal Investigator: Thomas Lane, MD UCSD
  More Information

No publications provided

Responsible Party: Thomas A. Lane, MD, Professor of Pathology, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00808080     History of Changes
Other Study ID Numbers: 070768
Study First Received: December 12, 2008
Last Updated: April 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Diego:
AML

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013