Skip to content

Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia

Telomere Length and Telomerase Mutations in Pediatric Acute Myeloid Leukemia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01247584
Enrollment
234
Registered
2010-11-24
Start date
2010-11-30
Completion date
Unknown
Last updated
2016-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

childhood acute myeloid leukemia/other myeloid malignancies, childhood acute erythroleukemia (M6), childhood acute megakaryocytic leukemia (M7), childhood acute monoblastic leukemia (M5a), childhood acute monocytic leukemia (M5b), childhood acute myeloblastic leukemia without maturation (M1), childhood acute myelomonocytic leukemia (M4), childhood acute myeloblastic leukemia with maturation (M2)

Brief summary

RATIONALE: Studying bone marrow samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in samples from young patients with acute myeloid leukemia.

Detailed description

OBJECTIVES: * To compare the frequency of germline telomerase mutations in pediatric patients with acute myeloid leukemia (AML) demonstrating prolonged myelosuppression, defined as ≥ 1 episode \> 35 days of neutrophil count recovery after chemotherapy, to the pediatric patients with the expected myelosuppression, defined as consistently \< 35 days of neutrophil count recovery after chemotherapy. * To assess association between telomerase mutations and incidence of grade 3 or 4 mucositis, relapse, and death. * To compare germline (remission) telomere length in pediatric AML patients demonstrating delayed bone marrow recovery with the pediatric patients with consistently expected recovery. * To assess whether a correlation between telomere length and incidence of grade 3 or 4 mucositis, relapse, and death exist. OUTLINE: This is a multicenter study. Cryopreserved bone marrow samples are analyzed for DNA sequencing and mutation by Sanger-based sequencing methods, quantitative PCR, and SeqMan Pro (Lasergene from DNAStar). Results are then compared with previously published data and existing databases to determine the allele frequency in control populations.

Interventions

GENETICDNA analysis
GENETICmutation analysis
GENETICpolymerase chain reaction
OTHERlaboratory biomarker analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Children's Oncology Group
Lead SponsorNETWORK

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia * Enrolled on CCG-2961 and meeting 1 of the following criteria: * More than 35 days to recover to an ANC \> 500/mm³ after any course of chemotherapy * Consistently recovered \< 35 days to an ANC \> 500/mm³ after all courses of chemotherapy * Available cryopreserved cell from diagnostic and end-of-therapy samples PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Design outcomes

Primary

MeasureTime frame
Frequency of mutations
Relapse-free survival
Overall survival
Difference in telomere length

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026