View Clinical Trial (Medical Research Study)
A Clinical Trial of Cytotoxic T Cells Augmenting Autologous Hematopoietic Stem Cell (AHSC) Transplantation for Acute Myeloid Leukemia (AML) - NCT00808080-92093(Clinical Trial 259264)
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| City: |
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LA Jolla |
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State:
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CA |
| Zip Code: |
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92093 |
| Conditions: |
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AML |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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 |
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| Study is available at: |
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UCSD
LA Jolla, CA 92093
United States
Primary Contact:
Thomas Lane, MD
Email: tlane@ucsd.edu
Phone: 858-822-6600
Secondary Contact:
Thomas Lane, MD
Email: tlane@ucsd.edu
Phone: 858-822-6600 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
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