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

This study has been completed.
Sponsor:
Information provided by:
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00667927
First received: April 24, 2008
Last updated: April 25, 2008
Last verified: April 2008
  Purpose

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).


Condition Intervention Phase
Acute Myeloid Leukemia
Drug: Busulfan
Drug: Cyclophosphamide
Drug: Mesna
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: March 1991
Study Completion Date: January 2008
Primary Completion Date: January 1995 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Drug: Busulfan
See Detailed Description section for description of treatment plan.
Other Name: Myleran
Drug: Cyclophosphamide
See Detailed Description section for description of treatment plan.
Other Name: Cytoxan, CTX
Drug: Mesna
See Detailed Description section for description of treatment plan.
Other Name: MESNCX

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.
  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667927

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Gregory A Hale, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Hale, Gregory A, St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00667927     History of Changes
Other Study ID Numbers: AMLREM
Study First Received: April 24, 2008
Last Updated: April 25, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Autologous bone marrow transplant
gene marking

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Busulfan
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 20, 2014