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

Children's Oncology Group

Status: Completed

Conditions: Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1; Recurrent Childhood Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Childhood Acute Myeloid Leukemia in Remission; Recurrent Childhood Acute Lymphoblastic Leukemia; Adult Acute Promyelocytic Leukemia With PML-RARA; Childhood Acute Myeloid Leukemia; Childhood Acute Lymphoblastic Leukemia in Remission; Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11

Treatments: Other: Laboratory Biomarker Analysis

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT01005277

NCI-2009-00325 (Registry Identifier)

U10CA098543 (U.S. NIH Grant/Contract)

COG-ABTR02B1 (Other Identifier)

ABTR02B1

CDR0000271322 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

2,000 participants in 1 patient group

Ancillary-Correlative (genetic polymorphisms)

Description:

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.

Treatment:

Other: Laboratory Biomarker Analysis