Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia, A Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01688752
• Other study ID #: 2012NTLS086
• Status: Withdrawn
• Phase: N/A
• First received: September 17, 2012
• Last updated: August 21, 2014

Study information

• Verified date: August 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This is a prospective cohort study assessing measures of cardiometabolic status, body composition, IR and GH response to stimulation after therapy in children (age 7-21 years) treated for ALL. Patients and sibling controls will be recruited from the Pediatric Hematology-Oncology Clinic at the University of Minnesota Amplatz Children's Hospital.

Description:

This is a prospective cohort study with two groups: survivors of acute lymphoblastic leukemia (ALL) who have recently completed therapy (cases) and healthy siblings (controls) frequency matched by age and sex. Subjects in each group will have two visits. For cases, the first visit will be approximately 6 months after completion of treatment for ALL; for their siblings, the first visit occur at approximately the same time. For both cases and controls, the second visit will be 2 to 2.5 years after the first visit.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 21 Years

Eligibility

Inclusion Criteria:

• Patients

• Age 7 years to less than or equal to 21 years at time of study enrollment.

• Acute lymphoblastic leukemia (ALL) as first cancer diagnosis and in first complete remission. Any subtype is eligible.

• Study enrollment must take place at/after six months of completion of all chemotherapy.

• Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients = 16 years of age.

• Any prior ALL therapy is allowable.

• Siblings

• Age 7 years to less than or equal to 21 years at time of study enrollment.

• Sibling of ALL patient.

Exclusion Criteria:

• Patients

• Diagnosis of diabetes mellitus prior to ALL diagnosis or at time of study enrollment.

• Current pregnancy

• Prior hematopoietic cell transplant.

• Receiving growth hormone replacement or corticosteroids at the time of enrollment.

• Siblings

• Previously diagnosed with malignancy.

• Diagnosis of diabetes mellitus.

• Current pregnancy

• Receiving growth hormone replacement or corticosteroids at the time of enrollment.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiometabolic Profile	To determine the cardiometabolic profile (as measured by a single score based on adiposity, serum lipids, and vascular function) shortly after therapy (6 months after completion of therapy [Visit 1]) and again 2.5-3 yrs after completion of therapy (Visit 2) in 300 ALL patients, and compare with 200 sibling controls.	up to 2.5-3 Years	No
Secondary	Prevalence of Blunted Stimulated Growth Hormone Response	To determine the prevalence of blunted stimulated GH response suggesting GH deficiency (peak GH <7mcg/L) in ALL survivors and controls: GH level will be obtained at baseline, then +30, +60, +90 and +120 minutes after clonidine (5 mcg/kg up to 200 mcg by mouth), followed by infusion of arginine (0.5 grams/kg up to 30 grams) with a series of GH levels at +140, +160, +180, +210, and +240 minutes. Blunted response to GH stimulation will be defined as peak GH level<7 mcg/L.	Between 2.5 and 3 Years	No