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

Sponsored by:	St. Jude Children's Research Hospital
Information provided by:	St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:	NCT00667927

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 I

MedlinePlus related topics: Bone Marrow Transplantation Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Mesna Cyclophosphamide Busulfan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment
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

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. Drug: Cyclophosphamide See Detailed Description section for description of treatment plan. Drug: Mesna See Detailed Description section for description of treatment plan.

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:

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.
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.
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

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

Related Info This link exits the ClinicalTrials.gov site

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

Keywords provided by St. Jude Children's Research Hospital:

Autologous bone marrow transplant
gene marking

Study placed in the following topic categories:

Leukemia
Busulfan
Acute myelogenous leukemia
Cyclophosphamide

Leukemia, Myeloid
Leukemia, Myeloid, Acute
Mesna
Acute myelocytic leukemia

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

Neoplasms
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009