Acute Myeloid Leukemia Clinical Trial
Official title:
Autologous Bone Marrow Transplant for Children With AML in First Complete Remission: Use of Marker Genes to Investigate the Biology of Marrow Reconstitution and the Mechanism of Relapse
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).
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:
1. 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.
2. 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.
3. the mechanisms of autologous reconstitution, and the effects of stimuli which modify
the process.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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