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

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ClinicalTrials.gov Identifier: NCT00808080
Recruitment Status : Terminated (lack of accrual)
First Posted : December 15, 2008
Results First Posted : February 22, 2016
Last Update Posted : February 22, 2016
Sponsor:
Information provided by (Responsible Party):

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
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
Primary Completion Date : June 2013
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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 15, 2008    Key Record Dates
Results First Posted: February 22, 2016
Last Update Posted: February 22, 2016
Last Verified: January 2016

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

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