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
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Condition or disease | Intervention/treatment |
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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 |
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 |
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 |

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

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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 |
Inclusion Criteria:
- Treated on COG-2961 or COG-AAML03P1
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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

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
United States, California | |
Children's Oncology Group | |
Monrovia, California, United States, 91006-3776 |
Principal Investigator: | Monica Thakar, MD | Children's Oncology Group |
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 |