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

Children's Oncology Group2,000 enrolled

Overview

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.

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

2,000

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Assessed with Fisher's exact test.

Time frame: Up to 8 years

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

Assessed with Pearson's chi square statistic test

Time frame: Up to 8 years

Differences in overall survival

Evaluated using the log rank statistic.

Time frame: Up to 8 years

Disease-free survival (DFS)

Evaluated using the log rank statistic.

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

Relapse-free survival

Evaluated using the logrank statistic.

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

Etiology of leukemia: Chi square test

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

Time frame: 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.

Time frame: Up to 8 years

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes