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

Completed

• Conditions: Childhood Acute Monoblastic Leukemia (M5a); Childhood Acute Minimally Differentiated Myeloid Leukemia (M0); Childhood Acute Myeloblastic Leukemia With Maturation (M2); Refractory Anemia With Excess Blasts; Childhood Acute Monocytic Leukemia (M5b); Fanconi Anemia; Secondary Myelodysplastic Syndromes; Childhood Acute Erythroleukemia (M6); Childhood Acute Megakaryocytic Leukemia (M7); Childhood Acute Myelomonocytic Leukemia (M4)
• Interventions: Other: laboratory biomarker analysis

• Registration Number: NCT01146210
• Lead Sponsor: Children's Oncology Group

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2010-06-16
• Study First Submitted QC: 2010-06-16
• Study First Posted: 2010-06-17
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-13
• Last Update Posted: 2016-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-correlative	laboratory biomarker analysis	Previously collected cryopreserved cells are analyzed via western blot to identify patients with Fanconi anemia.

Primary Outcome Measures

Name	Time	Method
Identification of Fanconi anemia patients	Up to 5 months
Identification of children at high risk of having Fanconi anemia	Up to 5 months

Trial Locations

Locations (1)

Children's Oncology Group; 🇺🇸 Monrovia, California, United States