A Pilot Phase II Study of Immunotherapy for the Treatment of AML, ALL, BP CML, and MDS Relapsed After Allogeneic Transplantation
This is a pilot phase II open label study testing the activity and feasibility of utilizing
a regimen to boost the immune system in order to treat AML, ALL, blast phase CML, and MDS
relapse after allogeneic transplantation. The regimen is a step-wise use of withdrawal of
immunosuppression, cytoreduction if needed, administration of GM-CSF and pegylated IFN α-2b
to patients who relapsed after an allogeneic transplant and will assess efficacy.
Relapse is the major problem following allogeneic hematopoietic progenitor cell transplants.
There is currently no standard way to treat leukemia that relapsed after transplant, and
patients have a poor prognosis.
A retrospective analysis of patients treated at Emory showed that administration of GM-CSF
and interferon-alpha-2b was well-tolerated and affected long-term remissions in a small
number of relapsed patients (after allogeneic transplant). Pre-clinical and clinical data
from ours and other centers showed that relapsed leukemic blasts have down-regulation of
co-stimulatory molecules and a tendency to evade the immune system. Cytokines can
up-regulate co-stimulatory molecules on leukemic blasts and have been shown to increase the
cytotoxicity of T-cells. This effect may be beneficial as a graft vs. leukemia effect for
patients with relapse after allogeneic transplant.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the efficacy of GM-CSF and pegylated interferon-alpha 2b when administered to patients with AML, ALL, blast phase CML, and MDS relapse after allogeneic transplantation, defined as progression-free survival of > 33% at 3 months
Martha Arellano, MD
Emory University Winship Cancer Institute
United States: Institutional Review Board
|Emory University Winship Cancer Institute||Atlanta, Georgia 30322|