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Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01247584
First Posted: November 24, 2010
Last Update Posted: May 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  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
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Telomere Length and Telomerase Mutations in Pediatric Acute Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Frequency of mutations
  • Relapse-free survival
  • Overall survival
  • Difference in telomere length

Biospecimen Retention:   Samples With DNA
bone marrow

Estimated Enrollment: 234
Study Start Date: November 2010
Primary Completion Date: May 2016 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosis of acute myeloid leukemia.
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247584


Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Maria M. Gramatges, MD Texas Children's Hospital
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01247584     History of Changes
Other Study ID Numbers: AAML11B2
COG-AAML11B2 ( Other Identifier: Children's Oncology Group )
NCI-2011-02846 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AAML11B2 ( Other Identifier: Children's Oncology Group )
First Submitted: November 23, 2010
First Posted: November 24, 2010
Last Update Posted: May 19, 2016
Last Verified: May 2016

Keywords provided by Children's Oncology Group:
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
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms