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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01533168
First Posted: February 15, 2012
Last Update Posted: May 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  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
  • 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

Biospecimen Retention:   Samples With DNA
cell samples

Estimated Enrollment: 12
Study Start Date: February 2012
Primary Completion Date: May 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533168


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

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01533168     History of Changes
Other Study ID Numbers: AALL12B1
COG-AALL12B1
CDR0000724799
AALL12B1 ( Other Identifier: COG )
NCI-2012-00246 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: February 9, 2012
First Posted: February 15, 2012
Last Update Posted: May 18, 2016
Last Verified: May 2016

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
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
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


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