Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11NCT01005277
Study of Biomarkers in DNA Samples From Patients With Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
An observational study of Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 and Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1, run by Children's Oncology Group at 1 site in United States.
Trial summary
This research study is looking at biomarkers in DNA samples from patients with acute lymphoblastic leukemia or acute myeloid leukemia. Studying samples of DNA from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1, Adult Acute Promyelocytic Leukemia With PML-RARA
- What is being tested?
- Laboratory Biomarker Analysis
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2002to 5 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- DNA samples available from patients meeting the following criteria:
- Infants with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML)
- Patients with pre-B ALL, including responders vs non-responders in selected genotypes [hyperdiploid, hypodiploid, t(12;21), t(9;22), t(1;19), and t(4;11)] and responders and non-responders regardless of genotype
- Pediatric patients with AML registered on POG-9421
- Adult patients with ALL, including t(8.21), inv(16), t(15;17), complex cytogenetics, and secondary AML
- Pediatric patients with relapsed ALL enrolled on COG-AALL01P2
- Pediatric patients enrolled on COG-9900 and other CCG or POG trials
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Childrens Oncology Group
Philadelphia, Pennsylvania, 19104
About this study
Official title: Genetic Polymorphisms in ALL Samples Submitted to Gene Array Analysis
This research study is looking at biomarkers in DNA samples from patients with acute lymphoblastic leukemia or acute myeloid leukemia. Studying samples of DNA from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- Collect DNA samples from patients with cytogenetically, well characterized, and uniformly treated acute lymphoblastic leukemia or acute myeloid leukemia for use in analysis of a wide range of host factors influencing etiology and outcome of the disease.
II. Identify host factors that can be determined at onset of treatment to predict outcome of chemotherapy, and thus modify the therapy administered.
OUTLINE:
Previously collected DNA samples are analyzed for polymorphisms at a variety of loci. Gene expression and expression profiles are correlated with genotype and therapy outcomes.
- Conditions
- Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1, Adult Acute Promyelocytic Leukemia With PML-RARA, Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia, Childhood Acute Myeloid Leukemia in Remission
- Being tested
- Laboratory Biomarker Analysis
- Medical subject headings
- Leukemia, Myelomonocytic, Acute, Leukemia, Promyelocytic, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma
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 (genetic polymorphisms) | Previously collected DNA samples are analyzed for polymorphisms at a variety of loci. Gene expression and expression profiles are correlated with genotype and therapy outcomes. Receives: Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in induction outcome, dichotomized into complete remission or no remission
Assessed with Fisher's exact test.
Measured: Up to 8 years
Differences in induction outcome, dichotomized into complete remission or no remission
Assessed with Pearson's chi square statistic test
Measured: Up to 8 years
Differences in overall survival
Evaluated using the log rank statistic.
Measured: Up to 8 years
Disease-free survival (DFS)
Evaluated using the log rank statistic.
Measured: Time from the end of induction to relapse or death, assessed up to 8 years
Relapse-free survival
Evaluated using the logrank statistic.
Measured: Time from the end of induction to marrow relapse or death from progressive disease, censoring on deaths from other causes, assessed up to 8 years
Etiology of leukemia: Chi square test
Chi square test will be used to determine the differences in distribution of genotypes between cases and controls.
Measured: Up to 8 years
Etiology of leukemia: Fisher's exact test
Fisher's exact test will be used to determine the differences in distribution of genotypes between cases and controls.
Measured: Up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study start17 Apr 2002
- Primary completion5 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11Studies 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stella Davies, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005277
- Sponsor's protocol ID
- ABTR02B1
- Other IDs
- NCI-2009-00325, CDR0000271322, COG-ABTR02B1, ABTR02B1, ABTR02B1, ABTR02B1, U10CA098543
- Status last verified
- Oct 2017
- First submitted
- 29 Oct 2009
- Last updated
- 14 Jul 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Polymorphisms in ALL Samples Submitted to Gene Array Analysis
- ClinicalTrials.gov ID
- NCT01005277
- Acronym / sponsor ID
- ABTR02B1
- Conditions
- Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1, Adult Acute Promyelocytic Leukemia With PML-RARA, Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia, Childhood Acute Myeloid Leukemia in Remission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Apr 2002 (actual)
- Primary completion
- 5 May 2016 (actual)
- First posted
- 30 Oct 2009 (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 looking at biomarkers in DNA samples from patients with acute lymphoblastic leukemia or acute myeloid leukemia. Studying samples of DNA from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
Detailed description
PRIMARY OBJECTIVES:
- Collect DNA samples from patients with cytogenetically, well characterized, and uniformly treated acute lymphoblastic leukemia or acute myeloid leukemia for use in analysis of a wide range of host factors influencing etiology and outcome of the disease.
II. Identify host factors that can be determined at onset of treatment to predict outcome of chemotherapy, and thus modify the therapy administered.
OUTLINE:
Previously collected DNA samples are analyzed for polymorphisms at a variety of loci. Gene expression and expression profiles are correlated with genotype and therapy outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (genetic polymorphisms) | – | Other: Laboratory Biomarker AnalysisPreviously collected DNA samples are analyzed for polymorphisms at a variety of loci. Gene expression and expression profiles are correlated with genotype and therapy outcomes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- DNA samples available from patients meeting the following 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 (genetic polymorphisms) |
Primary outcome
Differences in induction outcome, dichotomized into complete remission or no remission
Time frame: Up to 8 years
Assessed with Fisher's exact test.
Differences in induction outcome, dichotomized into complete remission or no remission
Time frame: Up to 8 years
Assessed with Pearson's chi square statistic test
Differences in overall survival
Time frame: Up to 8 years
Evaluated using the log rank statistic.
Disease-free survival (DFS)
Time frame: Time from the end of induction to relapse or death, assessed up to 8 years
Evaluated using the log rank statistic.
Relapse-free survival
Time frame: Time from the end of induction to marrow relapse or death from progressive disease, censoring on deaths from other causes, assessed up to 8 years
Evaluated using the logrank statistic.
Etiology of leukemia: Chi square test
Time frame: Up to 8 years
Chi square test will be used to determine the differences in distribution of genotypes between cases and controls.
Etiology of leukemia: Fisher's exact test
Time frame: Up to 8 years
Fisher's exact test will be used to determine the differences in distribution of genotypes between cases and controls.
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 14 Jul 2022.
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Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
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.
Stella Davies 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 Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 and Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1, 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 7 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 14 Jul 2022. 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?
Differences in induction outcome, dichotomized into complete remission or no remission (time frame: Up to 8 years). The study lists 7 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 14 Jul 2022.