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:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01533168
First received: February 9, 2012
Last updated: May 4, 2015
Last verified: May 2015
  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
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
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:


Further study details as provided by Children's Oncology Group:

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 ]

Biospecimen Retention:   Samples With DNA

cell samples


Estimated Enrollment: 12
Study Start Date: February 2012
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
Sampling Method:   Non-Probability Sample
Study Population

Patients With Acute Lymphoblastic Leukemia

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01533168

Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Norman J. Lacayo, MD Stanford University
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01533168     History of Changes
Other Study ID Numbers: AALL12B1, COG-AALL12B1, CDR0000724799, AALL12B1, NCI-2012-00246
Study First Received: February 9, 2012
Last Updated: May 4, 2015
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
childhood acute lymphoblastic leukemia in remission
recurrent childhood acute lymphoblastic leukemia
B-cell childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Neoplasm, Residual
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on August 03, 2015