Acute Myeloid Leukemia Clinical Trial
SCT Plus Immune Therapy in Average Risk AML/MDS
Summary
Allogeneic stem cell transplantation followed by targeted immune therapy with Gemtuzumab Ozogamicin (Mylotarg) will be given to patients with average risk AML or MDS.
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
Disease Status:
AML 1st CR with a matched family donor
AML 1st CR with unrelated donor
AML 2nd CR or CRP
MDS and < or = 5% bone marrow myeloblasts at diagnosis
Disease Immunophenotype:
Disease must express a minimum of > or = 10% CD33 positivity for patients with AML
Organ Function:
Adequate renal function, adequate liver function, adequate cardiac function, adequate pulmonary function
Exclusion Criteria:
Patients with active CNS AML disease at time of preparative regimen
Secondary MDS
Poor cytogenetics
Female patients who are pregnant
Karnofsky <70% or Lansky <50% if 10 years or less
Age >25 years
Seropositive for HIV
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There is 1 Location for this study
Valhalla New York, 10595, United States
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