A Pilot Study of G-CSF to Disrupt the Bone Marrow Microenvironment in Relapsed or Refractory Acute Lymphoblastic Leukemia
In this study, we will combine G-CSF as priming prior to and during the administration of
salvage chemotherapy regimen in ALL. Abundant data suggests that leukemic cells receive key
growth and survival signals from the bone marrow microenvironment. Our preclinical data
show that 4-5 days of G-CSF treatment is associated with a loss of osteoblasts and decreases
expression of key chemokine/ cytokines which support lymphocyte development. The
investigators hypothesize that G-CSF will disrupt the protective effects of the bone marrow
microenvironment and augment the effect of chemotherapy in adults with ALL. This is a pilot
study of G-CSF priming in adult patients with relapsed or refractory ALL to determine the
feasibility and to characterize the effect of G-CSF treatment on the marrow
microenvironment.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Treatment-related mortality
30 days after start of treatment
Yes
Geoffrey Uy, M.D.
Principal Investigator
Washington University School of Medicine
United States: Institutional Review Board
201104323
NCT01331590
September 2011
September 2015
Name | Location |
---|---|
Washington University School of Medicine | Saint Louis, Missouri 63110 |
University of Chicago Medical Center | Chicago, Illinois 60637 |