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

Chronic Myelomonocytic Leukemia Clinical Trial

Official title:

Identification of de Novo Fanconi Anemia Patients Using FANCD2 Western Blots

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. 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