Allogenic Stem Cell Transplantation in Patients With High Risk CD33+ AML/MDS/JMML (High Risk)

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML, JMML, MDS, Allogenic Atem Cell Transplant, Gemtuzumab Ozogamicin Read More

Eligibility

Inclusion Criteria:

Disease Status

• AML Induction Failure
• AML in 1st, 2nd, or 3rd Relapse (>10% bone marrow blasts)
• AML greater than or equal to 3rd CR
• MDS with >6% bone marrow blasts at diagnosis
• Secondary MDS with less than or equal to 5% bone marrow myeloblasts at diagnosis
• JMML with >6% bone marrow myeloblasts at diagnosis

Disease Immunophenotype Patients (AML only) receiving gemtuzumab ozogamicin must express minimum of >10% or =10% CD33 positivity. Patients with <10% CD33 positivity will not receive gemtuzumab ozogamicin.

Organ Function

Patients must have adequate organ function as defined below:

• Adequate renal function defined as:
• Serum creatinine <1.5 x normal, or
• Creatinine clearance or radioisotope GFR 40 ml/min/m2 or >60 ml/min/1.73 m2 or an equivalent GFR as determined by the institutional normal range
• Adequate liver function defined as:
• Total bilirubin 1.5 x normal, or SGOT (AST) or SGPT (ALT) <2.0 x normal or =2.0 x normal
• Adequate cardiac function defined as:
• Shortening fraction of >27% by echocardiogram, or
• Ejection fraction of >47% by radionuclide angiogram or echocardiogram
• Adequate pulmonary function defined as:
• DLCO >55% or =55% by PFT
• For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >94% on room air

Exclusion Criteria:

• Patients with active CNS AML/JMML/MDS disease at time of conditioning therapy
• Female patients who are pregnant (positive HCG)
• Karnofsky <50% or Lansky <50% if 10 years or less
• Age >65 years
• Has received gemtuzumab in the previous 30 days or has not recovered from prior gemtuzumab therapy.