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

Secondary Acute Myeloid Leukemia Clinical Trial

Official title:

Genetic Polymorphisms in ALL Samples Submitted to Gene Array Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01005277
• Other study ID #: ABTR02B1
• Secondary ID: NCI-2009-00325CD
• Status: Completed
• Start date: April 17, 2002

Study information

• Verified date: October 2017
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. primary completion date: May 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• 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
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Leukemia, Promyelocytic, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Recurrence
• Recurrent Childhood Acute Lymphoblastic Leukemia
• Recurrent Childhood Acute Myeloid Leukemia
• Secondary Acute Myeloid Leukemia

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Childrens Oncology Group	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in induction outcome, dichotomized into complete remission or no remission	Assessed with Fisher's exact test.	Up to 8 years
Primary	Differences in induction outcome, dichotomized into complete remission or no remission	Assessed with Pearson's chi square statistic test	Up to 8 years
Primary	Differences in overall survival	Evaluated using the log rank statistic.	Up to 8 years
Primary	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
Primary	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
Primary	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
Primary	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