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

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ClinicalTrials.gov Identifier: NCT01146210

Recruitment Status : Completed

First Posted : June 17, 2010

Last Update Posted : May 17, 2016

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Children's Oncology Group

Study Description

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

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


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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Fanconi anemia Core binding factor acute myeloid leukemia Cytogenetically normal acute myeloid leukemia Familial acute myeloid leukemia with mutated CEBPA

MedlinePlus related topics: Anemia Leukemia

Genetic and Rare Diseases Information Center resources: Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Myelodysplastic Syndromes Juvenile Myelomonocytic Leukemia Chronic Myelomonocytic Leukemia Myelodysplastic Syndrome With Excess Blasts Fanconi Anemia Congenital Aplastic Anemia Fanconi Syndrome Acute Myeloblastic Leukemia With Maturation Acute Myeloblastic Leukemia Without Maturation Acute Erythroid Leukemia Acute Megakaryoblastic Leukemia Acute Myelomonocytic Leukemia Di Guglielmo's Syndrome Acute Monoblastic Leukemia Sideroblastic Anemia Pyridoxine-refractory Autosomal Recessive Nephropathic Cystinosis Primary Fanconi Syndrome Myelodysplastic/myeloproliferative Disease Chronic Myeloproliferative Disorders

U.S. FDA Resources

Groups and Cohorts

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

Primary Outcome Measures :

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

Biospecimen Retention: Samples With DNA

tumor tissue

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146210

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


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 Key Record Dates
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

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