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Telomere Length and Telomerase Mutations in Pediatric Acute Myeloid Leukemia


N/A
N/A
21 Years
Open (Enrolling)
Both
Leukemia

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Trial Information

Telomere Length and Telomerase Mutations in Pediatric Acute Myeloid Leukemia


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.

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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Frequency of mutations

Safety Issue:

No

Principal Investigator

Maria M. Gramatges, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Texas Children's Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000689840

NCT ID:

NCT01247584

Start Date:

November 2010

Completion Date:

Related Keywords:

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

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