Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01247584
First received: November 23, 2010
Last updated: November 30, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention
Leukemia
Genetic: DNA analysis
Genetic: mutation analysis
Genetic: polymerase chain reaction
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Telomere Length and Telomerase Mutations in Pediatric Acute Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Frequency of mutations [ Designated as safety issue: No ]
  • Relapse-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Difference in telomere length [ Designated as safety issue: No ]

Estimated Enrollment: 234
Study Start Date: November 2010
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247584

Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Maria M. Gramatges, MD Texas Children's Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Gregory H. Reaman, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01247584     History of Changes
Other Study ID Numbers: CDR0000689840, COG-AAML11B2
Study First Received: November 23, 2010
Last Updated: November 30, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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)

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014