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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01533168
First received: February 9, 2012
Last updated: February 11, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Leukemia
 Genetic: cytogenetic analysis
Genetic: nucleic acid sequencing
Other: diagnostic laboratory biomarker analysis
Other: laboratory biomarker analysis
Other: medical chart review

Study Type: Observational
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Identification and characterization of changes in clonal populations of B cells in children with ALL [ Designated as safety issue: No ]
  • Reclassification of patients as MRD positive at day 29 [ Designated as safety issue: No ]
  • Higher sensitivity detection that allow the stratification of the MRD population into 2 groups with lower and higher likelihood of relapse [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: February 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   1 Year to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533168

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Norman J. Lacayo, MD Stanford University
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Peter C. Adamson, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01533168     History of Changes
Other Study ID Numbers: CDR0000724799, COG-AALL12B1
Study First Received: February 9, 2012
Last Updated: February 11, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood acute lymphoblastic leukemia in remission
recurrent childhood acute lymphoblastic leukemia
B-cell childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasm, Residual
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes
Immunoglobulin Heavy Chains
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013