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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01146210
Other study ID # AAML10B2
Secondary ID NCI-2011-02219CO
Status Recruiting
Phase N/A
First received June 16, 2010
Last updated November 5, 2015
Start date October 2009

Study information

Verified date November 2015
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This research study is studying identification of de novo Fanconi anemia in younger patients with newly diagnosed acute myeloid leukemia. Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to Fanconi anemia in patients with acute myeloid leukemia.


Description:

PRIMARY OBJECTIVES:

I. Identify children with newly diagnosed acute myeloid leukemia (AML) treated on COG-2961 and COG-AAML03P1 who are at high risk of having de novo Fanconi anemia.

II. Procure diagnostic samples from the COG AML Biology Repository and identify Fanconi anemia patients using western blot techniques.

OUTLINE:

Previously collected cryopreserved cells are analyzed via western blot to identify patients with Fanconi anemia.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date
Est. primary completion date January 2100
Accepts healthy volunteers No
Gender Both
Age group N/A to 21 Years
Eligibility Inclusion Criteria:

- Treated on COG-2961 or COG-AAML03P1

- At high risk of having Fanconi anemia, defined as meeting one the following groups of clinical criteria:

- Group 1: Prolonged neutropenia after induction, severe regimen-related toxicity (mucositis, veno-occlusive disease, end-organ damage)

- Group 2: Early non-relapse death (induction, consolidation)

- Group 3: Small-for-weight, secondary malignancies

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms

  • Anemia
  • Anemia, Refractory, with Excess of Blasts
  • Childhood Acute Erythroleukemia (M6)
  • Childhood Acute Megakaryocytic Leukemia (M7)
  • Childhood Acute Minimally Differentiated Myeloid Leukemia (M0)
  • Childhood Acute Monoblastic Leukemia (M5a)
  • Childhood Acute Monocytic Leukemia (M5b)
  • Childhood Acute Myeloblastic Leukemia With Maturation (M2)
  • Childhood Acute Myeloblastic Leukemia Without Maturation (M1)
  • Childhood Acute Myelomonocytic Leukemia (M4)
  • Childhood Myelodysplastic Syndromes
  • Chronic Myelomonocytic Leukemia
  • de Novo Myelodysplastic Syndromes
  • Fanconi Anemia
  • Fanconi Syndrome
  • Leukemia
  • Leukemia, Erythroblastic, Acute
  • Leukemia, Megakaryoblastic, Acute
  • Leukemia, Monocytic, Acute
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Acute
  • Leukemia, Myelomonocytic, Acute
  • Leukemia, Myelomonocytic, Chronic
  • Myelodysplastic Syndromes
  • Preleukemia
  • Refractory Anemia
  • Refractory Anemia With Excess Blasts
  • Refractory Anemia With Excess Blasts in Transformation
  • Refractory Anemia With Ringed Sideroblasts
  • Secondary Myelodysplastic Syndromes
  • Syndrome
  • Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies

Intervention

Other:
laboratory biomarker analysis
Correlative studies

Locations

Country Name City State
United States Children's Oncology Group Monrovia California

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Identification of children at high risk of having Fanconi anemia Up to 5 months No
Primary Identification of Fanconi anemia patients Up to 5 months No
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