Studying DNA in Blood and Bone Marrow Samples From Younger Patients With Acute Myeloid Leukemia

Completed

• Conditions: Adult Acute Myeloid Leukemia in Remission; Childhood Acute Myeloid Leukemia in Remission
• Interventions: Other: Laboratory Biomarker Analysis

• Registration Number: NCT01024127
• Lead Sponsor: Children's Oncology Group

Brief Summary

This research trial studies deoxyribonucleic acid (DNA) in blood or bone marrow samples from younger patients with acute myeloid leukemia. Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.

Detailed Description

PRIMARY OBJECTIVES:

l. Perform a genome-wide scan to test for loci associated with acute myeloid leukemia (AML) relapse and infection risk.

II. Validate positive associations seen in the genome-wide scan with a fine mapping approach.

III. Perform simulated clinical trials using germline genetic variation data to test the feasibility of using genetic data to inform the clinical care of pediatric patients with AML.

OUTLINE:

Germline DNA is obtained from previously collected peripheral blood or bone marrow samples for array-based genotyping studies, including genome-wide association studies (single nucleotide polymorphisms) and fine mapping genotyping. Clinical trial simulations are performed to test the clinical applicability of using genetic variation data in the management of infectious complications.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-01
• Study First Submitted QC: 2009-12-01
• Study First Posted: 2009-12-02
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

• Diagnosis of AML

  • In remission

• Adequate DNA from peripheral blood or bone marrow samples

• Concurrent enrollment on CCG-2961, COG-AAML03P1, COG-AAML0531, AML-93, AML-97, AML-04,AML-09, or Canada AML Infection clinical trial required

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-correlative (predictors of AML treatment outcomes)	Laboratory Biomarker Analysis	Germline DNA is obtained from previously collected peripheral blood or bone marrow samples for array-based genotyping studies, including genome-wide association studies (single nucleotide polymorphisms) and fine mapping genotyping. Clinical trial simulations are performed to test the clinical applicability of using genetic variation data in the management of infectious complications.

Primary Outcome Measures

Name	Time	Method
Incidence of first acute myeloid leukemia relapse	Up to 2 years
Rate of invasive bacterial infections defined as the number of invasive infection episodes divided by the days at risk	From study entry date to completion of therapy date provided on the final Reporting Period case reporting form, assessed up to 2 years

Trial Locations

Locations (1)

Children's Oncology Group; 🇺🇸 Philadelphia, Pennsylvania, United States