Acute Myeloid Leukemia Clinical Trial
Immunochemotherapy and AlloSCT in Patients With High Risk CD33+ AML/MDS
Summary
Targeted immune therapy with gemtuzumab ozogamicin (Mylotarg) in combination with chemotherapy followed by allogeneic stem cell transplantation will be given to patients with high risk acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS).
Full Description
Gemtuzumab ozogamicin in combination with busulfan and cyclophosphamide (immunochemotherapy) conditioning followed by allogeneic stem cell transplantation + anti-thymocyte globulin (unrelated donors only) in patients with high risk CD33+AML or MDS meeting eligibility criteria.
Eligibility Criteria
Inclusion Criteria:
Disease Status:
History of AML Induction/Reinduction Failure
AML 1st Complete Remission (CR) with poor cytogenetics
AML 2nd CR with minimal residual disease (MRD)
AML 3rd CR
AML in refractory relapse but ≤25% bone marrow leukemia blasts
MDS with >6% bone marrow blasts at diagnosis
Secondary MDS with ≤5% bone marrow myeloblasts at diagnosis
Disease Immunophenotype:
• Disease must express a minimum of >/= 10% CD33+ for patients with AML
Organ Function:
• Adequate renal function, adequate liver function, adequate cardiac function, adequate pulmonary function Age: ≤25 years of age Donor: matched family donor, unrelated cord blood donor, unrelated adult donor
Exclusion Criteria:
Patients with active central nervous system (CNS) AML/MDS disease at time of conditioning therapy
Female patients who are pregnant
Karnofsky <50% or Lansky <50% if 10 years or less
Age >25 years
Has received gemtuzumab in the previous 30 days or has not recovered from prior gemtuzumab therapy.
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There is 1 Location for this study
Valhalla New York, 10595, United States
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