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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01146210
First received: June 16, 2010
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Identification of de Novo Fanconi Anemia Patients Using FANCD2 Western Blots

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Identification of children at high risk of having Fanconi anemia [ Time Frame: Up to 5 months ] [ Designated as safety issue: No ]
  • Identification of Fanconi anemia patients [ Time Frame: Up to 5 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

tumor tissue


Estimated Enrollment: 20
Study Start Date: October 2009
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ancillary-correlative
Previously collected cryopreserved cells are analyzed via western blot to identify patients with Fanconi anemia.
Other: laboratory biomarker analysis
Correlative studies

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

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01146210

Locations
United States, California
Children's Oncology Group Recruiting
Arcadia, California, United States, 91006-3776
Contact: Monica S. Thakar, MD    206-667-5946    msthakar@fhcrc.org   
Principal Investigator: Monica S. Thakar, MD         
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Monica Thakar, MD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01146210     History of Changes
Other Study ID Numbers: AAML10B2, NCI-2011-02219, COG-AAML10B2, CDR0000671437, AAML10B2, AAML10B2
Study First Received: June 16, 2010
Last Updated: February 14, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014