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

Genetic Polymorphisms in ALL Samples Submitted to Gene Array Analysis

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.

Study Overview

• Status: Completed
• Conditions: Secondary Acute Myeloid Leukemia; Childhood Acute Myeloid Leukemia in Remission; Childhood Acute Lymphoblastic Leukemia in Remission; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1; Childhood Acute Myeloid Leukemia; Adult Acute Promyelocytic Leukemia With PML-RARA
• Intervention / Treatment: Other: Laboratory Biomarker Analysis

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Childrens Oncology Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ancillary-Correlative (genetic polymorphisms); 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.	Other: Laboratory Biomarker Analysis; Correlative studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in induction outcome, dichotomized into complete remission or no remission	Assessed with Fisher's exact test.	Up to 8 years
Differences in induction outcome, dichotomized into complete remission or no remission	Assessed with Pearson's chi square statistic test	Up to 8 years
Differences in overall survival	Evaluated using the log rank statistic.	Up to 8 years
Disease-free survival (DFS)	Evaluated using the log rank statistic.	Time from the end of induction to relapse or death, assessed up to 8 years
Relapse-free survival	Evaluated using the logrank statistic.	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
Etiology of leukemia: Chi square test	Chi square test will be used to determine the differences in distribution of genotypes between cases and controls.	Up to 8 years
Etiology of leukemia: Fisher's exact test	Fisher's exact test will be used to determine the differences in distribution of genotypes between cases and controls.	Up to 8 years

Collaborators and Investigators

• Sponsor: Children's Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Stella Davies, Children's Oncology Group

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 17, 2002
• Primary Completion (ACTUAL): May 5, 2016

Study Registration Dates

• First Submitted: October 29, 2009
• First Submitted That Met QC Criteria: October 29, 2009
• First Posted (ESTIMATE): October 30, 2009

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Disease Attributes; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Recurrence; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia, Promyelocytic, Acute
• Other Study ID Numbers: ABTR02B1 (OTHER: CTEP); U10CA098543 (U.S. NIH Grant/Contract); NCI-2009-00325 (REGISTRY: CTRP (Clinical Trial Reporting Program)); CDR0000271322; COG-ABTR02B1