Completed

Neurobehavioral Outcomes in Childhood Acute Lymphoblastic Leukemia. A Limited Non-Therapeutic Study

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Hematologic Diseases
+11

+ Immune System Diseases
+ Immunoproliferative Disorders
From 6 to 16 Years
See all eligibility criteria
How is the trial designed

Observational
Study Start: May 2004
See protocol details

Summary

Principal SponsorChildren's Oncology Group
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2004Actual date on which the first participant was enrolled.

OBJECTIVES: * Compare neurobehavioral functioning, specifically memory, attention, executive function, visual-motor integration, and processing speed, in children previously treated with steroids (prednisone vs dexamethasone) and intrathecal therapy (methotrexate alone vs methotrexate, cytarabine, and hydrocortisone) for childhood acute lymphoblastic leukemia. * Correlate non-treatment risk factors, such as gender, age at diagnosis, and time since termination of prior therapy, with impaired neurobehavioral function in these patients. * Correlate neurobehavioral complications with quality-of-life of these patients. OUTLINE: This is a multicenter, cohort study. Patients are assigned to 1 of 2 cohorts (prior treatment per CCG-1922 \[prednisone vs dexamethasone\] vs prior treatment per CCG-1952 \[intrathecal (IT) methotrexate vs IT methotrexate, cytarabine, and hydrocortisone\]). Patients in each cohort are stratified according to age at diagnosis, gender, and time since prior treatment termination. * Cohort A (CCG-1922): Patients undergo physical and neurological examination, neurobehavioral evaluation, and quality of life assessment. Neurobehavioral evaluations assess memory, attention, and executive function. * Cohort B (CCG-1952): Patients undergo evaluation as above. Neurobehavioral evaluations assess visual-motor integration and processing speed. PROJECTED ACCRUAL: A total of 448 patients (224 per cohort) will be accrued for this study within 4 years.

Official TitleNeurobehavioral Outcomes in Childhood Acute Lymphoblastic Leukemia. A Limited Non-Therapeutic Study 
NCT00085176
Principal SponsorChildren's Oncology Group
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
286 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.

How participants are selected
Participants are selected without using randomization. They may be chosen based on convenience, access, or willingness to participate. This approach is common when random selection isn’t practical.
Another way to select participants is through a probability sample, where participants are chosen randomly, so everyone has an equal chance to be included.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.Other Ways to Collect Data
Retrospective
: These studies use existing medical records or past data.

Cross-sectional
: These studies collect data at one single point in time.

Others
: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 6 to 16 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Hematologic Diseases
Immune System Diseases
Immunoproliferative Disorders
Leukemia
Leukemia, Lymphoid
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Nervous System Diseases
Poisoning
Neurotoxicity Syndromes
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Chemically-Induced Disorders
Criteria

DISEASE CHARACTERISTICS: * Diagnosis of standard-risk childhood acute lymphoblastic leukemia (ALL) * In continuous first remission * No history of CNS pathology requiring radiotherapy or surgery * Prior enrollment on one of the following Children's Cancer Group (CCG) protocols AND terminated therapy at least 1 year ago: * CCG-1922 (prednisone vs dexamethasone) * CCG-1952 (intrathecal methotrexate vs triple intrathecal therapy) * No prior enrollment on CCG-1952 arm III * No history of pre-existing neurodevelopmental disorder before diagnosis of ALL (e.g., mental retardation, Down syndrome, seizure disorder, or traumatic brain injury) * No neuropsychological assessment within the past 6 months PATIENT CHARACTERISTICS: Age * 6.5 to 16 years Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Reading, speaking, and listening comprehension of English by patient required (English and/or Spanish by parent) * No history of very low birth weight (\< 1,500 grams) PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * See Disease Characteristics Radiotherapy * See Disease Characteristics Surgery * See Disease Characteristics Other * Concurrent stimulants allowed


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Data analysis for each of the two clinical trials will be conducted separately. The primary objectives will be two-sided comparisons of various mean neurobehavioral scores between the two treatment arms within each study.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 31 locations
Suspended
Phoenix Children's HospitalPhoenix, United StatesSee the location
Suspended
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, United States
Suspended
Jonathan Jaques Children's Cancer Center at Miller Children's HospitalLong Beach, United States
Suspended
Childrens Hospital Los AngelesLos Angeles, United States

Completed31 Study Centers
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