Identification of de Novo Fanconi Anemia in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia

Children's Oncology Group

Status: Completed

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

Treatments: Other: laboratory biomarker analysis

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT01146210

AAML10B2 (Other Identifier)

CDR0000671437 (Other Identifier)

NCI-2011-02219 (Registry Identifier)

COG-AAML10B2 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

20 participants in 1 patient group

Ancillary-correlative

Description:

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

Treatment:

Other: laboratory biomarker analysis