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

Completed · Phase 1

Conditions studied: Acute Myeloid Leukemia

In brief

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).

Key facts

Study ID

NCT00667927

Run by

St. Jude Children's Research Hospital

People needed

17

Starts

1991-03-01

Expected to finish

2008-01-01

Last updated by the study team

2008-04-28

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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%

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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