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

Identification of de Novo Fanconi Anemia Patients Using FANCD2 Western Blots

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.

Study Overview

• Status: Completed
• Conditions: Chronic Myelomonocytic Leukemia; Fanconi Anemia; Childhood Acute Erythroleukemia (M6); Childhood Acute Megakaryocytic Leukemia (M7); 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; Secondary Myelodysplastic Syndromes; de Novo Myelodysplastic Syndromes; Refractory Anemia; Refractory Anemia With Excess Blasts; Refractory Anemia With Excess Blasts in Transformation; Childhood Acute Minimally Differentiated Myeloid Leukemia (M0); Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies; Refractory Anemia With Ringed Sideroblasts
• Intervention / Treatment: Other: laboratory biomarker analysis

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • California
    • Monrovia, California, United States, 91006-3776
      • Children's Oncology Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients treated on trials COG-2961 or COG-AAML03P1. Also patients at high risk of having Fanconi anemia meeting other criteria.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ancillary-correlative; Previously collected cryopreserved cells are analyzed via western blot to identify patients with Fanconi anemia.	Other: laboratory biomarker analysis; Correlative studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Identification of children at high risk of having Fanconi anemia	Up to 5 months
Identification of Fanconi anemia patients	Up to 5 months

Collaborators and Investigators

• Sponsor: Children's Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Monica Thakar, MD, Children's Oncology Group

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: June 16, 2010
• First Submitted That Met QC Criteria: June 16, 2010
• First Posted (Estimate): June 17, 2010

Study Record Updates

• Last Update Posted (Estimate): May 17, 2016
• Last Update Submitted That Met QC Criteria: May 13, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Neoplasms by Histologic Type; Neoplasms; Kidney Diseases; Urologic Diseases; Disease; Bone Marrow Diseases; Hematologic Diseases; Genetic Diseases, Inborn; Myeloproliferative Disorders; DNA Repair-Deficiency Disorders; Precancerous Conditions; Myelodysplastic-Myeloproliferative Diseases; Anemia, Hypoplastic, Congenital; Anemia, Aplastic; Congenital Bone Marrow Failure Syndromes; Bone Marrow Failure Disorders; Renal Tubular Transport, Inborn Errors; Syndrome; Myelodysplastic Syndromes; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Leukemia, Myelomonocytic, Acute; Leukemia, Myelomonocytic, Chronic; Leukemia, Myelomonocytic, Juvenile; Anemia; Leukemia, Monocytic, Acute; Leukemia, Megakaryoblastic, Acute; Leukemia, Erythroblastic, Acute; Fanconi Syndrome; Fanconi Anemia; Anemia, Refractory, with Excess of Blasts; Anemia, Refractory
• Other Study ID Numbers: AAML10B2 (Other Identifier: CTEP); NCI-2011-02219 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); COG-AAML10B2 (Other Identifier: Childrens Oncology Group); CDR0000671437 (Other Identifier: Clinical Trials.gov)