Autologous Bone Marrow Transplant for Children With Acute Myelogenous Leukemia (AML) in First Complete Remission
NCT ID: NCT00667927
Last Updated: 2008-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
17 participants
INTERVENTIONAL
1991-03-31
2008-01-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Busulfan
See Detailed Description section for description of treatment plan.
Cyclophosphamide
See Detailed Description section for description of treatment plan.
Mesna
See Detailed Description section for description of treatment plan.
Interventions
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Busulfan
See Detailed Description section for description of treatment plan.
Cyclophosphamide
See Detailed Description section for description of treatment plan.
Mesna
See Detailed Description section for description of treatment plan.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients enrolled on the AML-87 study in second or subsequent remission are eligible for this protocol.
Exclusion Criteria
* 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%
1 Year
18 Years
ALL
No
Sponsors
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St. Jude Children's Research Hospital
OTHER
Responsible Party
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St. Jude Children's Research Hospital
Principal Investigators
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Gregory A Hale, MD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Related Links
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Related Info
Other Identifiers
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AMLREM
Identifier Type: -
Identifier Source: org_study_id