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Childhood Acute Erythroleukemia (M6) | Identification of de Novo Fanconi Anemia in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia

Childhood Acute Erythroleukemia (M6) research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

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

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:laboratory biomarker analysisCorrelative studies

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Ancillary-correlativePreviously collected cryopreserved cells are analyzed via western blot to identify patients with Fanconi anemia.

Study Status

Completed

Start Date: May 2009

Completed Date: May 2016

Phase:

Type: Observational

Design:

Primary Outcome: Identification of children at high risk of having Fanconi anemia

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Monica Thakar, MD

Lead Sponsor: Children's Oncology Group

Collaborator: National Cancer Institute (NCI)

More information:https://clinicaltrials.gov/show/NCT01146210

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