NCT00667927

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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: 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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Busulfan	See Detailed Description section for description of treatment plan.
DRUG	Cyclophosphamide	See Detailed Description section for description of treatment plan.
DRUG	Mesna	See Detailed Description section for description of treatment plan.

Timeline

• Start date: 1991-03-01
• Primary completion: 1995-01-01
• Completion: 2008-01-01
• First posted: 2008-04-28
• Last updated: 2008-04-28

Locations

1 site across 1 country: United States