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

NCT00667927 | Completed Phase 1

• 1 other identifier: AMLREM
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Acute Myeloid Leukemia

Keywords

Autologous bone marrow transplant; gene marking

Outcome Measures

Primary Outcomes (1)

• 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).

  2 years post transplant

Study Arms (1)

1

OTHER

Drug: Busulfan; Drug: Cyclophosphamide; Drug: Mesna

Interventions

Busulfan DRUG

See Detailed Description section for description of treatment plan.

Also known as: Myleran

1

Cyclophosphamide DRUG

See Detailed Description section for description of treatment plan.

Also known as: Cytoxan, CTX

1

Mesna DRUG

See Detailed Description section for description of treatment plan.

Also known as: MESNCX

1

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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%

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Busulfan; Cyclophosphamide; Mesna

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Sulfhydryl Compounds

Study Officials

• Gregory A Hale, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 28, 2008
• Study Start: March 1, 1991
• Primary Completion: January 1, 1995
• Study Completion: January 1, 2008
• Last Updated: April 28, 2008

Record last verified: 2008-04

Locations

US (1)