Clinical trial NCT01005277: Study of Biomarkers in DNA Samples From Patients With Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
Official title: Genetic Polymorphisms in ALL Samples Submitted to Gene Array Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Childhood Acute Myeloid Leukemia
Childhood Acute Myeloid Leukemia in Remission
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-10-30
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE

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.

Eligibility 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

Primary outcomes:
measure: Differences in induction outcome, dichotomized into complete remission or no remission
timeFrame: Up to 8 years
measure: Differences in induction outcome, dichotomized into complete remission or no remission
timeFrame: Up to 8 years
measure: Differences in overall survival
timeFrame: Up to 8 years
measure: Disease-free survival (DFS)
timeFrame: Time from the end of induction to relapse or death, assessed up to 8 years
measure: Relapse-free survival
timeFrame: 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
measure: Etiology of leukemia: Chi square test
timeFrame: Up to 8 years
measure: Etiology of leukemia: Fisher's exact test
timeFrame: Up to 8 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Childrens Oncology Group
state: Pennsylvania
Study officials:
affiliation: Children's Oncology Group
name: Stella Davies
role: PRINCIPAL_INVESTIGATOR
References: