A Clinical Trial of Cytotoxic T Cells Augmenting Autologous Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia
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.
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:
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
2.5 years estimated
Yes
Thomas Lane, MD
Principal Investigator
UCSD
United States: Food and Drug Administration
070768
NCT00808080
January 2010
June 2013
Name | Location |
---|---|
UCSD | San Diego, California 92103 |