Acute Myeloid Leukemia Clinical Trial
Autologous Bone Marrow Transplant for Children With Acute Myelogenous Leukemia (AML) in First Complete Remission
Summary
This study proposes to transfer marker genes (detectable genetic traits or segments of DNA that can be identified and tracked) into aliquots of marrow obtained for Bone Marrow Transplant (BTM) in patients in remission of Acute Myelogenous Leukemia (AML).
Full Description
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.
Eligibility Criteria
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%
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There is 1 Location for this study
Memphis Tennessee, 38105, United States
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