As part of a multi-center study done in collaboration with the National Cancer Institute and University of Pennsylvania, a team of six John Theurer Cancer Center researchers conducted a clinical trial to evaluate the effectiveness of infusing cultured donor immune cells known as "T-rapa" cells after stem cell transplantation into patients being treated for blood-related cancers.
The T-rapa cell is a type of white blood cell that is cultured with rapamycin, co-stimulation and interleukin-4. These cells express a balanced Th2/Th1 effector phenotype -- a T-cell profile that is thought to protect against transplant rejection and improve the outcome of patients by reducing graft versus host disease and improving graft versus tumor effect.
Patients were assigned to one of two study arms: those receiving T-rapa cell therapy (day 14) after transplantation with a pre-transplantation regimen of either induction chemotherapy (Arm A) or after outpatient, low-preparative chemotherapy (on day 0) (Arm B). Of 65 patients between the two groups, high-risk non-Hodgkin's lymphoma (NHL) was the most frequent diagnosis (25 patients), followed by non-high-risk NHL (11), acute myelogenous leukemia/myelodysplastic syndrome (8), myeloma (7), chronic lymphocytic leukemia (6), Hodgkin's disease (5), and chronic myelogenous leukemia (3).
Arm A had the best results, with 37.5% (15/40) of recipients in sustained complete remission following the study and a median survival probability of 63.6% at 24 months post-transplantation. The authors conclude that pre-emptive infusion with T-rapa cells (ex-vivo manufactured T-rapa donor derived cells) that express a balanced Th2/Th1 effector phenotype represents a novel approach to safely accelerate transplant engraftment and harness graft-versus-tumor effects after low-intensity conditioning.
This research was presented at the annual meeting of the American Society of Hematology (ASH) taking place December 4-7, 2010 in Orlando, Florida.
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