Allogeneic stem cell transplantation followed by targeted immune therapy with Gemtuzumab Ozogamicin (Mylotarg) will be given to patients with average risk AML or MDS.
Reduced intensity conditioning regimen of Busulfan (Bu) and Fludarabine (Flu) + Anti-Thymocyte Globulin (ATG ) (unrelated donors only) or reduced toxicity conditioning regimen of Bu/Flu/alemtuzumab, or reduced hepatic toxicity regimen of melphan/Flu/alemtuzumab and AlloSCT, followed by Gemtuzumab Ozogamicin consolidation in patients with average risk AML/MDS meeting eligibility criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Gemtuzumab, 9.0 mg/m2, will be given IV over 2 hours two times post allogeneic transplantation.
New York Medical College
Valhalla, New York, United States
to evaluate incidence of graft failure
If three or more of the first ten patients experience primary or secondary graft failure, we will discontinue the study.
Time frame: Day +42
to evaluate survival rates
Event-free survival and overall survival after RI AlloSCT and targeted immunotherapy in patients with average risk AML/MDS.
Time frame: 1 year
to determine toxicity
to monitor for serious adverse events related to protocol investigational therapy
Time frame: 1 year
Minor histocompatibility antigen
To measure the minor histocompatibility antigen expression on AML tissue, donor and recipient, and the development of MHA specific CTLs post AlloSCT.
Time frame: 1 year
Chimerism
To determine the degree of mixed/complete donor chimerism after RI AlloSCT in patients with average risk AML/MDS.
Time frame: 1 year
Graft-versus-host disease
To estimate the risk of acute and chronic GVHD following RI AlloSCT and FK506/MMF GVHD prophylaxis in patients with average risk AML/MDS.
Time frame: 1 Year
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