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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease

Intervention/treatment

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; Refractory Anemia; Refractory Anemia With Excess Blasts; Refractory Anemia With Excess Blasts in Transformation; Refractory Anemia With Ringed Sideroblasts; Secondary Myelodysplastic Syndromes; Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies

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 Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	20 participants
Observational Model:	Case-Only
Time Perspective:	Retrospective
Official Title:	Identification of de Novo Fanconi Anemia Patients Using FANCD2 Western Blots
Study Start Date :	May 2009
Actual Primary Completion Date :	May 2016
Actual Study Completion Date :	May 2016

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Identification of children at high risk of having Fanconi anemia [ Time Frame: Up to 5 months ]
2. Identification of Fanconi anemia patients [ Time Frame: Up to 5 months ]

Biospecimen Retention:   Samples With DNA

tumor tissue

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	up to 21 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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.

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Monica Thakar, MD	Children's Oncology Group

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Children's Oncology Group
ClinicalTrials.gov Identifier:	NCT01146210 History of Changes
Other Study ID Numbers:	AAML10B2; NCI-2011-02219 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); COG-AAML10B2 ( Other Identifier: Childrens Oncology Group ); CDR0000671437 ( Other Identifier: Clinical Trials.gov ); AAML10B2 ( Other Identifier: Children's Oncology Group ); AAML10B2 ( Other Identifier: CTEP )
First Posted:	June 17, 2010
Last Update Posted:	May 17, 2016
Last Verified:	May 2016

Additional relevant MeSH terms:

Anemia; Anemia, Refractory; Anemia, Refractory, with Excess of Blasts; Fanconi Anemia; Anemia, Aplastic; Anemia, Hypoplastic, Congenital; Syndrome; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Preleukemia; Leukemia, Myelomonocytic, Acute; Leukemia, Myelomonocytic, Chronic; Leukemia, Myelomonocytic, Juvenile	Leukemia, Monocytic, Acute; Fanconi Syndrome; Leukemia, Erythroblastic, Acute; Leukemia, Megakaryoblastic, Acute; Disease; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Bone Marrow Diseases; Precancerous Conditions; Myelodysplastic-Myeloproliferative Diseases; Genetic Diseases, Inborn; DNA Repair-Deficiency Disorders; Metabolic Diseases