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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


Phase 1
1 Year
18 Years
Not Enrolling
Both
Acute Myeloid Leukemia

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Trial Information

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


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.


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%

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To estimate the continuous complete remission rate at 2 years for children with AML in first complete remission treated with Autologous Bone Marrow Transplant (ABMT).

Outcome Time Frame:

2 years post transplant

Safety Issue:

Yes

Principal Investigator

Gregory A Hale, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

AMLREM

NCT ID:

NCT00667927

Start Date:

March 1991

Completion Date:

January 2008

Related Keywords:

  • Acute Myeloid Leukemia
  • Autologous bone marrow transplant
  • gene marking
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794