Status:
TERMINATED
A Clinical Trial of Cytotoxic T Cells Augmenting Autologous Hematopoietic Stem Cell (AHSC) Transplantation for Acute Myeloid Leukemia (AML)
Lead Sponsor:
Thomas A. Lane, MD
Conditions:
AML
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00808080
Start Date
January 1 2010
End Date
June 1 2013
Last Update
April 9 2019
Active Locations (1)
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1
UCSD
La Jolla, California, United States, 92093