Genetic Test To Identify Previously Undetectable Minimal Residual Disease in Cell Samples From Younger Patients With Acute Lymphoblastic Leukemia

Next-Generation Sequencing of Immunoglobulin Heavy Chain Variable Region to Identify Previously Undetectable Minimal Residual Disease in Children With Acute Lymphoblastic Leukemia With Prognostic Significance

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01533168

Enrollment

Registered

2012-02-15

Start date

2012-02-29

Completion date

Unknown

Last updated

2016-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

childhood acute lymphoblastic leukemia in remission, recurrent childhood acute lymphoblastic leukemia, B-cell childhood acute lymphoblastic leukemia

Brief summary

RATIONALE: Testing for minimal residual disease in cell samples from patients with acute lymphoblastic leukemia may help doctors plan better treatment. PURPOSE: This research trial studies a genetic test in identifying previously undetectable minimal residual disease in cell samples from younger patients with acute lymphoblastic leukemia.

Detailed description

OBJECTIVES: * To identify and characterize changes in clonal populations of B cells in children with acute lymphoblastic leukemia (ALL) at diagnosis and Day 29 of induction. * To define the ability of this technology to reclassify patients as minimal residual disease (MRD) positive at Day 29 of induction. * To determine whether more sensitive detection of MRD at Day 29 would have clinical prognostic value in children with ALL. OUTLINE: DNA extracted from diagnostic cells are analyzed for immunoglobulin heavy chain variable region by next-generation sequencing.

Interventions

GENETICcytogenetic analysis

GENETICnucleic acid sequencing

OTHERdiagnostic laboratory biomarker analysis

OTHERlaboratory biomarker analysis

OTHERmedical chart review

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 30 Years

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Samples from patients enrolled on COG-AALL0232 with standard-risk (SR) or high-risk (HR) acute lymphoblastic leukemia (ALL) with varying levels of MRD and relapse * Diagnostic cells and Day 29 cells from patients that have not relapsed and are 5 years from diagnosis on protocol COG-AALL0232 * Diagnostic cells and Day 29 cells from patients that are matched for age, sex, initial white blood cell (WBC) count, and cytogenetics that have relapsed PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Design outcomes

Primary

Measure	Time frame
Identification and characterization of changes in clonal populations of B cells in children with ALL	—
Reclassification of patients as MRD positive at day 29	—
Higher sensitivity detection that allow the stratification of the MRD population into 2 groups with lower and higher likelihood of relapse	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026