Back to resultsA Clinical Trial of Cytotoxic T Cells Augmenting Autologous Hematopoietic Stem Cell (AHSC) Transplantation for Acute Myeloid Leukemia (AML) (AMLCTL)
Primary Purpose
AML
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AMLCTL
Sponsored by
About this trial
This is an interventional treatment trial for AML focused on measuring AML
Eligibility 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
Sites / Locations
- UCSD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Biologic
Arm Description
AML_CTL cells
Outcomes
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00808080
Brief Title
A Clinical Trial of Cytotoxic T Cells Augmenting Autologous Hematopoietic Stem Cell (AHSC) Transplantation for Acute Myeloid Leukemia (AML)
Acronym
AMLCTL
Official Title
A Clinical Trial of Cytotoxic T Cells Augmenting Autologous Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
lack of accrual
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas A. Lane, MD
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AML
Keywords
AML
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biologic
Arm Type
Experimental
Arm Description
AML_CTL cells
Intervention Type
Biological
Intervention Name(s)
AMLCTL
Intervention Description
Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
Description
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.
Time Frame
2.5 years estimated
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Lane, MD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial of Cytotoxic T Cells Augmenting Autologous Hematopoietic Stem Cell (AHSC) Transplantation for Acute Myeloid Leukemia (AML)
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