Clinical trial NCT01146210: Identification of de Novo Fanconi Anemia in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia
Official title: Identification of de Novo Fanconi Anemia Patients Using FANCD2 Western Blots
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-06-17
Enrollment: 20
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Identification of children at high risk of having Fanconi anemia
timeFrame: Up to 5 months
measure: Identification of Fanconi anemia patients
timeFrame: Up to 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Monrovia
country: United States
facility: Children's Oncology Group
state: California
Study officials:
affiliation: Children's Oncology Group
name: Monica Thakar, MD
role: PRINCIPAL_INVESTIGATOR
References: