A Clinical Trial of Cytotoxic T Cells Augmenting Autologous Hematopoietic Stem Cell (AHSC) Transplantation for Acute Myeloid Leukemia (AML) (AMLCTL)
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.
|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|
- 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 ]
- 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 ]
|Study Start Date:||January 2010|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)
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.