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OpenTrials
Completed

NCT Number: NCT01005277

Study of Biomarkers in DNA Samples From Patients With Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

This research study is looking at biomarkers in DNA samples from patients with acute lymphoblastic leukemia or acute myeloid leukemia. Studying samples of DNA from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

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Key information

Conditions

Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1 Adult Acute Promyelocytic Leukemia With PML-RARA Childhood Acute Lymphoblastic Leukemia in Remission Childhood Acute Myeloid Leukemia Childhood Acute Myeloid Leukemia in Remission Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Myelomonocytic, Acute Leukemia, Promyelocytic, Acute Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Recurrent Childhood Acute Lymphoblastic Leukemia Recurrent Childhood Acute Myeloid Leukemia Secondary Acute Myeloid Leukemia

Sex eligibility

All sexes

Study type

Observational

Primary location

Childrens Oncology Group

Philadelphia, Pennsylvania, 19104, United States

About this study

PRIMARY OBJECTIVES:

I. Collect DNA samples from patients with cytogenetically, well characterized, and uniformly treated acute lymphoblastic leukemia or acute myeloid leukemia for use in analysis of a wide range of host factors influencing etiology and outcome of the disease.

II. Identify host factors that can be determined at onset of treatment to predict outcome of chemotherapy, and thus modify the therapy administered.

OUTLINE:

Previously collected DNA samples are analyzed for polymorphisms at a variety of loci. Gene expression and expression profiles are correlated with genotype and therapy outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • DNA samples available from patients meeting the following criteria:
  • Infants with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML)
  • Patients with pre-B ALL, including responders vs non-responders in selected genotypes [hyperdiploid, hypodiploid, t(12;21), t(9;22), t(1;19), and t(4;11)] and responders and non-responders regardless of genotype
  • Pediatric patients with AML registered on POG-9421
  • Adult patients with ALL, including t(8.21), inv(16), t(15;17), complex cytogenetics, and secondary AML
  • Pediatric patients with relapsed ALL enrolled on COG-AALL01P2
  • Pediatric patients enrolled on COG-9900 and other CCG or POG trials

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. Differences in induction outcome, dichotomized into complete remission or no remission

    Time frame: Up to 8 years

    Assessed with Fisher's exact test.

  2. Differences in induction outcome, dichotomized into complete remission or no remission

    Time frame: Up to 8 years

    Assessed with Pearson's chi square statistic test

  3. Differences in overall survival

    Time frame: Up to 8 years

    Evaluated using the log rank statistic.

  4. Disease-free survival (DFS)

    Time frame: Time from the end of induction to relapse or death, assessed up to 8 years

    Evaluated using the log rank statistic.

  5. Relapse-free survival

    Time frame: Time from the end of induction to marrow relapse or death from progressive disease, censoring on deaths from other causes, assessed up to 8 years

    Evaluated using the logrank statistic.

  6. Etiology of leukemia: Chi square test

    Time frame: Up to 8 years

    Chi square test will be used to determine the differences in distribution of genotypes between cases and controls.

  7. Etiology of leukemia: Fisher's exact test

    Time frame: Up to 8 years

    Fisher's exact test will be used to determine the differences in distribution of genotypes between cases and controls.

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Genetic Polymorphisms in ALL Samples Submitted to Gene Array Analysis

Important dates

Study start
2002
Primary completion
2016
First posted
Oct 30, 2009
Registry last updated
Jul 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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