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

April 25, 2008 updated by: St. Jude Children's Research Hospital

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Drug: Busulfan
See Detailed Description section for description of treatment plan.
Other Names:
  • Myleran
Drug: Cyclophosphamide
See Detailed Description section for description of treatment plan.
Other Names:
  • Cytoxan, CTX
Drug: Mesna
See Detailed Description section for description of treatment plan.
Other Names:
  • MESNCX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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).
Time Frame: 2 years post transplant
2 years post transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Jude Children's Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1991

Primary Completion (Actual)

January 1, 1995

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

April 24, 2008

First Submitted That Met QC Criteria

April 25, 2008

First Posted (Estimate)

April 28, 2008

Study Record Updates

Last Update Posted (Estimate)

April 28, 2008

Last Update Submitted That Met QC Criteria

April 25, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMLREM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe