Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia

Leukemia Clinical Trial

Official title:

Telomere Length and Telomerase Mutations in Pediatric Acute Myeloid Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01247584
• Other study ID #: AAML11B2
• Secondary ID: COG-AAML11B2NCI-
• Status: Completed
• Phase: N/A
• First received: November 23, 2010
• Last updated: May 17, 2016
• Start date: November 2010

Study information

• Verified date: May 2016
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Genetic:
• DNA analysis

• mutation analysis

• polymerase chain reaction

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of mutations			No
Primary	Relapse-free survival			No
Primary	Overall survival			No
Primary	Difference in telomere length			No

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database