Childhood Acute Erythroleukemia (M6)NCT01146210
Identification of de Novo Fanconi Anemia in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia
An observational study of Childhood Acute Erythroleukemia (M6) and Childhood Acute Megakaryocytic Leukemia (M7), run by Children's Oncology Group at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Childhood Acute Erythroleukemia (M6), Childhood Acute Megakaryocytic Leukemia (M7), Childhood Acute Minimally Differentiated Myeloid Leukemia (M0)
- What is being tested?
- laboratory biomarker analysis
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients treated on trials COG-2961 or COG-AAML03P1. Also patients at high risk of having Fanconi anemia meeting other criteria.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Oncology Group
Monrovia, California, 91006-3776
About this study
Official title: Identification of de Novo Fanconi Anemia Patients Using FANCD2 Western Blots
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- 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)
- Being tested
- laboratory biomarker analysis
- Medical subject headings
- Leukemia, Myelomonocytic, Chronic, Fanconi Anemia, Anemia, Refractory, Anemia, Refractory, with Excess of Blasts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-correlative | Previously collected cryopreserved cells are analyzed via western blot to identify patients with Fanconi anemia. Receives: Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of children at high risk of having Fanconi anemia
Measured: Up to 5 months
Identification of Fanconi anemia patients
Measured: Up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startMay 2009
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Acute Erythroleukemia (M6)Studies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Monica Thakar, MD, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146210
- Sponsor's protocol ID
- AAML10B2
- Other IDs
- NCI-2011-02219, COG-AAML10B2, CDR0000671437, AAML10B2, AAML10B2
- Status last verified
- May 2016
- First submitted
- 16 Jun 2010
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of de Novo Fanconi Anemia Patients Using FANCD2 Western Blots
- ClinicalTrials.gov ID
- NCT01146210
- Acronym / sponsor ID
- AAML10B2
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2009
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 17 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-correlative | – | Other: laboratory biomarker analysisPreviously collected cryopreserved cells are analyzed via western blot to identify patients with Fanconi anemia. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients treated on trials COG-2961 or COG-AAML03P1. Also patients at high risk of having Fanconi anemia meeting other criteria.
Key inclusion criteria (5 listed)
- Treated on COG-2961 or COG-AAML03P1
- At high risk of having Fanconi anemia, defined as meeting one the following groups of clinical criteria:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laboratory biomarker analysisCorrelative studies | Other | Ancillary-correlative |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica Thakar, MD principal investigator
Children's Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Acute Erythroleukemia (M6) and Childhood Acute Megakaryocytic Leukemia (M7), run by Children's Oncology Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of children at high risk of having Fanconi anemia (time frame: Up to 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2016; AzTrials last refreshed its copy on 8 Nov 2026.