Allogeneic Stem Cell Transplantation Followed By Targeted Immune Therapy In Average Risk Acute Myelogenous Leukemia/Myelodysplastic Syndrome/Juvenile Myelomonocytic Leukemia (Aml/Mds/Jmml)
Gemtuzumab Ozogamicin (CMA-676) is a chemotherapeutic agent consisting of a recombinant
humanized anti-CD33 antibody conjugated with calicheamicin, a highly potent cytotoxic
antitumor antibiotic. The antibody portion of Gemtuzumab binds specifically to the CD33
antigen, a sialic acid-dependent adhesion protein expressed on the surface of leukemic
blasts, normal and leukemic myeloid colony-forming cells, including leukemic clonogenic
precursors, but excluding pluripotent hematopoietic stem cells and nonhematopoietic cells.
This results in formation of a complex that is internalized, upon which the calicheamicin
derivative is released within the lysosomes of the myeloid cell. The free calicheamicin
derivative then binds to DNA, resulting in DNA double strand breaks and consequential cell
death. Over 80% of AML patients possess myeloid blast cells with CD33 surface antigen
expression.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the feasibility and toxicity of a Reduced Intensity (RI) regimen, AlloSCT followed by targeted immune therapy, Gemtuzumab Ozogamicin (GO) , in average risk AML/JMML/MDS.
Day 60, Day 100, Day 180, 1 year, 2 years
Yes
Monica Bhatia, MD
Principal Investigator
Columbia University
United States: Institutional Review Board
AAAA6378
NCT01020539
September 2002
September 2013
Name | Location |
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Columbia University Medical Center | New York, New York 10032 |