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

This study has been terminated.
(lack of accrual)
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: June 18, 2013
Last verified: June 2013
  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:


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 ]

Enrollment: 6
Study Start Date: January 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biologic
AML_CTL cells
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808080

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

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: June 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Diego:
AML

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

ClinicalTrials.gov processed this record on October 21, 2014