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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


N/A
1 Year
30 Years
Open (Enrolling)
Both
Leukemia

Thank you

Trial Information

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


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.

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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Identification and characterization of changes in clonal populations of B cells in children with ALL

Safety Issue:

No

Principal Investigator

Norman J. Lacayo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Federal Government

Study ID:

CDR0000724799

NCT ID:

NCT01533168

Start Date:

February 2012

Completion Date:

Related Keywords:

  • Leukemia
  • childhood acute lymphoblastic leukemia in remission
  • recurrent childhood acute lymphoblastic leukemia
  • B-cell childhood acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Neoplasm, Residual

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