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Clinical Trial COGAAML08B1

Title

AAML08B1 - Biology Study of Transient Myeloproliferative Disorder (TMD) in Children with Down Syndrome (DS)

Principal Investigator(s)

Haydar Frangoul

Details

  • Protocol No. COGAAML08B1
  • Open Date: 10/26/2011
  • Staging: N/A
  • Age Group: Children
  • Scope: National
  • Objective: Molecular features of TMD may influence outcome in Down syndrome patients and predict their risk of developing subsequent leukemia.
  • Disease Sites: Pediatrics; Pediatric Leukemia
  • Therapies: None Specified
  • Drugs: None Specified
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT00959283
  • Secondary Protocol No: Not Specified

Description

None Provided.

Eligibility

Ages Eligible for Study:N/A to 1 Year
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

DISEASE CHARACTERISTICS:
• Diagnosis of transient myeloproliferative disorder (TMD) at < 90 days of age and meeting 1 of the following criteria:
• A diagnosis of Down syndrome or Down syndrome mosaicism AND non-erythroid and non-lymphoid blasts (any amount) in the peripheral blood verified with a second sample
• Patients with typical physical characteristics of Down syndrome are allowed before cytogenetic or FISH confirmation of the diagnosis
• Trisomy 21-positive leukemic blasts documented by biopsy of any organ (including > 5% non-erythroid/non-lymphoid blasts documented by bone marrow aspirate or biopsy)
• Infants with isolated trisomy 21 positivity identified only in the leukemic blasts are allowed
• Institutional immunophenotype characterization is required for study enrollment
PATIENT CHARACTERISTICS:
• Not specified
PRIOR CONCURRENT THERAPY:
• Not specified