Autologous Bone Marrow Transplant for Children With Acute Myelogenous Leukemia (AML) in First Complete Remission

The primary objective of this study was to estimate the continuous complete remission rate at 2 years post transplant for children with AML in first complete remission treated with autologous BMT.

Secondary objectives used transduction of marker genes into autologous marrow to determine the following:

• whether the source of relapse after BMT for AML is residual malignant cells in the harvested marrow or in the patient, and whether marrow purging is therefore rational.
• whether the majority of AML, which lack genetic markers, represent abnormalities in a multi-lineage progenitor cell, and whether therefore, auto grafting/intensified chemotherapy is ever likely to augment the cure rate.
• the mechanisms of autologous reconstitution, and the effects of stimuli which modify the process.

Inclusion criteria

• Patients aged between 1 and 18 years at diagnosis with acute nonlymphocytic leukemia in first remission are eligible for this protocol.
• Patients enrolled on the AML-87 study in second or subsequent remission are eligible for this protocol.

Exclusion criteria

• Has an HLA-matched, MLC-compatible donor(unless parents and/or patient refuses transplant.
• Diagnosis of FAB M3 or FAB M3v (acute progranulocytic leukemia)
• Life expectancy limited by disease other than leukemia
• Significant cardiac disease (echo shortening fraction <25% or MUGA scan <50%)
• Severe renal dysfunction, i.e., creatinine clearance less than 60cc/1.73 m2/min
• Severe restrictive pulmonary disease (FCV less than 40% of predicted)
• Severe hepatic disease (bilirubin greater than 3 mg/dl or SGPT greater than 500IU)
• Severe personality disorder or mental illness
• Previous severe cystitis from cyclophosphamide
• Previous total dose of anthracyclines of >450 mg/m2
• Sever infection that on evaluation by the PI precludes ablative chemotherapy or successful transplantation
• Previous autologous transplant
• HIV reactivity
• Karnofsky score <70%