Metabolic Syndrome in Young Patients With Acute Lymphoblastic Leukemia in Remission

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IBiomarker/Laboratory analysis, Natural history/EpidemiologyActive1 to 20NCI, OtherCDR0000624471
VU-VICC-PED-0872, IRB# 081043, VICCPED0872, NCT00801346

Trial Description


RATIONALE: Gathering information about metabolic syndrome from young patients with acute lymphoblastic leukemia may help doctors learn more about the disease.

PURPOSE: This phase I trial is studying the metabolic syndrome in young patients with acute lymphoblastic leukemia in remission.

Further Study Information



  • To determine the incidence and prevalence of the components of metabolic syndrome (e.g., obesity, hypertension, dyslipidemia, and insulin resistance) in pediatric patients with acute lymphoblastic leukemia in remission.
  • To determine the trajectory of the onset of these components over a 1-year period in patients undergoing maintenance therapy.


  • To identify potential associations between components of metabolic syndrome and fatigue, health-related quality of life, family history, nutrition, and physical activity.
  • To identify potential biomarkers that are associated with clinical features of metabolic syndrome.
  • To evaluate whether patients will show a decrease in IGF-1 levels.

OUTLINE: This is a two-part study. Patients are enrolled in either part 1 or part 2.

  • Part 1: Patients undergo physical exam measurements (e.g., body mass index, waist circumference, and blood pressure) at baseline (during maintenance course 1) and at 12 months (during maintenance course 5). Patients also undergo blood sample collection at baseline and at 12 months to measure laboratory markers (e.g., fasting lipid profile, fasting insulin and glucose, IGF-1, leptin, and adiponectin levels). Patients or their parents complete a family history questionnaire at baseline and questionnaires to assess physical activity, quality of life, nutritional intake, and fatigue at baseline and at 6 and 12 months.
  • Part 2: Patients or their parents complete a family history questionnaire at baseline.

Eligibility Criteria


Part 1

  • Diagnosis of precursor B-cell acute lymphoblastic leukemia (ALL)
  • In first remission
  • In first 3 months of maintenance therapy
  • No T-cell ALL, very high-risk ALL, or infant ALL (< 1 year old at diagnosis)

Part 2

  • Diagnosis of precursor B-cell or T-cell ALL
  • In first remission
  • Must have been diagnosed and treated (at least to the maintenance phase) at the Division of Pediatric Oncology at the Vanderbilt-Ingram Cancer Center within the past 7 years
  • No very high-risk ALL or infant ALL (< 1 year old at diagnosis)


  • Not specified


  • See Disease Characteristics
  • No prior or concurrent cranial radiotherapy (Part 1)

Trial Contact Information

Trial Lead Organizations/Sponsors

Vanderbilt-Ingram Cancer Center

  • National Cancer Institute
Kathleen M. Von Wahlde
Adam J. Esbenshade, Principal Investigator

Trial Sites



Vanderbilt-Ingram Cancer Center

Clinical Trials Office - Vanderbilt-Ingram Cancer Center
Ph: 800-811-8480

Vanderbilt-Ingram Cancer Center - Cool Springs

Adam Esbenshade
Ph: 615-936-1762

Vanderbilt-Ingram Cancer Center at Franklin

Adam Esbenshade
Ph: 615-936-1762

Link to the current record.
NLM Identifier NCT00801346 processed this data on April 09, 2015

Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to