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

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

First Received on December 12, 2008. Last Updated on April 18, 2012 History of Changes

Sponsor:	Thomas A. Lane, MD
Information provided by (Responsible Party):	Thomas A. Lane, MD, University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00808080

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:

Genetics Home Reference related topics: familial acute myeloid leukemia with mutated CEBPA

MedlinePlus related topics: Acute Myeloid Leukemia Leukemia

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:

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 24, 2012