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CompletedNCT01024127Updated May 18, 2016

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

An observational study in Adult Acute Myeloid Leukemia in Remission and Childhood Acute Myeloid Leukemia in Remission, sponsored by Children's Oncology Group. Completed at 1 site in United States. Open to participants aged Up to 30 Years. Per ClinicalTrials.gov, last updated 2016-05-18.

Sponsored by Children's Oncology Group · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
2,500
Ages
Up to 30 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Adult Acute Myeloid Leukemia in Remission
  • Childhood Acute Myeloid Leukemia in Remission
03

In context

Leukemia

5,442 studies on the registry are indexed under Leukemia; 637 are open to participants now.

This study's planned enrollment of 2,500 is above the median of 120 across 744 observational studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Children's Oncology Group is the lead sponsor of 436 studies on the registry; 34 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Diagnosis of AML in remission

Eligibility criteria

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
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
2,500 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Ancillary-correlative (predictors of AML treatment outcomes)

    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.

    Other: Laboratory Biomarker Analysis

Interventions

  • OtherLaboratory Biomarker Analysis

    Correlative studies

06

What researchers measure

Primary outcomes

  1. Incidence of first acute myeloid leukemia relapse

    Time frame: Up to 2 years

  2. Rate of invasive bacterial infections defined as the number of invasive infection episodes divided by the days at risk

    Time frame: From study entry date to completion of therapy date provided on the final Reporting Period case reporting form, assessed up to 2 years

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Study locations

1 site
  • Children's Oncology Group
    Philadelphia, Pennsylvania 19104, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01024127
Lead sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Dec 2, 2009
Start date
Dec 2009
Primary completion
May 2016
Last update
May 18, 2016

Study contacts

Richard Aplenc, MD
principal investigator · Children's Oncology Group

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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