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NCT01533168 Clinical Trial

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

Leukemia Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01533168
Other study ID # AALL12B1
Secondary ID COG-AALL12B1CDR0
Status Completed
Phase N/A
First received February 9, 2012
Last updated May 17, 2016
Start date February 2012

Study information
Verified date May 2016
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 30 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Genetic:
• cytogenetic analysis

• nucleic acid sequencing

Other:
• diagnostic laboratory biomarker analysis

• laboratory biomarker analysis

• medical chart review

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Identification and characterization of changes in clonal populations of B cells in children with ALL No
Primary Reclassification of patients as MRD positive at day 29 No
Primary Higher sensitivity detection that allow the stratification of the MRD population into 2 groups with lower and higher likelihood of relapse No
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