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

Completed

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

• Registration Number: NCT01005277
• Lead Sponsor: Children's Oncology Group

Brief Summary

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.

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 Timeline

• Study Start: 2002-04-17
• Study First Submitted: 2009-10-29
• Study First Submitted QC: 2009-10-29
• Study First Posted: 2009-10-30
• Primary Completion: 2016-05-05
• Status Verified: 2017-10
• Last Update Submitted: 2022-07-12
• Last Update Posted: 2022-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Childrens Oncology Group; 🇺🇸 Philadelphia, Pennsylvania, United States