Childhood Acute Lymphoblastic Leukemia in RemissionNCT00897507
DNA Analysis of Tumor Tissue Samples From Young Patients With Acute Lymphoblastic Leukemia
An observational study of Childhood Acute Lymphoblastic Leukemia in Remission and Recurrent Childhood Acute Lymphoblastic Leukemia, run by Children's Oncology Group at 1 site in United States.
Trial summary
This laboratory study is looking at DNA in tumor tissue samples from young patients with acute lymphoblastic leukemia. DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Childhood Acute Lymphoblastic Leukemia in Remission, Recurrent Childhood Acute Lymphoblastic Leukemia
- What is being tested?
- Laboratory Biomarker Analysis
- How many people
- 520 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2004to 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Enrolled in clinical trial CCG-1891 or CCG-1952 with pediatric ALL
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: Single Nucleotide Polymorphisms and Relapse Risk in Standard Risk ALL
This laboratory study is looking at DNA in tumor tissue samples from young patients with acute lymphoblastic leukemia. DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment
Read the detailed description
PRIMARY OBJECTIVE:
- To validate significant associations between SNPs and treatment outcome and toxicity on Children's Cancer Group (CCG)-1891 on an independent sample set from a successor CCG study for standard risk acute lymphoblastic leukemia (ALL), CCG-1952.
II. To evaluate the role of SNPs in drug metabolizing enzymes and the development of veno-occlusive disease in patients on CCG-1952.
III. To evaluate interactions among genotypes and other risk factors for treatment response in a combined data set of CCG-1891 and CCG-1952 with recently developed analytic tools for high dimensional data.
IV. To develop predictive models utilizing genetic information obtained in Aim 1.1 and clinical data to predict treatment response and toxicity.
OUTLINE:
Tumor tissue samples undergo genotype assessment on the Pyrosequencing platform. Contingency tables and X^2 test performs a univariate analysis of the risk of relapse and genotype, and multivariable analyses using logistic regression. Cox proportional hazards evaluate the risk of relapse given genotype and other confounders. Genotype patterning, classification and regression trees, and multifactor dimensionality reduction evaluates for patterns of single nucleotide polymorphisms associated with toxicity and relapse risk.
- Conditions
- Childhood Acute Lymphoblastic Leukemia in Remission, Recurrent Childhood Acute Lymphoblastic Leukemia
- Being tested
- Laboratory Biomarker Analysis
- Medical subject headings
- 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 (genotype assessment) | Tumor tissue samples undergo genotype assessment on the Pyrosequencing platform. Contingency tables and X^2 test performs a univariate analysis of the risk of relapse and genotype, and multivariable analyses using logistic regression. Cox proportional hazards evaluate the risk of relapse given genotype and other confounders. Genotype patterning, classification and regression trees, and multifactor dimensionality reduction evaluates for patterns of single nucleotide polymorphisms associated with toxicity and relapse risk. Receives: Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leukemia Relapse
Contingency tables will be used to tabulate the relationship between relapse and genotype, race, leukemia cytogenetics, day 7 bone marrow status, and treatment arm
Measured: Day 7
Development of veno-occlusive disease in patients on CCG-1952
Classification and Regression Trees (CART), genotype patterning, Multifactor Dimensionality Reduction (MDR) techniques will be used to identify SNP combinations associated with risk of relapse and VOD
Measured: Day 28
Development of a predictive model of leukemia relapse
Predictive models will be developed utilizing genetic information obtained in Aim 1.1 and clinical data to predict treatment response
Measured: Day 28
Development of a predictive model of leukemia toxicity
Predictive models will be developed utilizing genetic information obtained in Aim 1.1 and clinical data to predict treatment toxicity.
Measured: Day 28
Secondary outcomes (1)
Development of grade III/IV toxicity as defined by the CCG toxicity criteria
Contingency tables will be used to tabulate categorical toxicities and toxicity severity grade.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study start13 May 2004
- 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 Childhood Acute Lymphoblastic Leukemia in RemissionStudies 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
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Richard Aplenc, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897507
- Sponsor's protocol ID
- AALL04B2
- Other IDs
- NCI-2009-00309, CDR0000371580, COG-AALL04B2, AALL04B2, AALL04B2, AALL04B2, U10CA098543
- Status last verified
- Oct 2017
- First submitted
- 9 May 2009
- Last updated
- 15 Aug 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Nucleotide Polymorphisms and Relapse Risk in Standard Risk ALL
- ClinicalTrials.gov ID
- NCT00897507
- Acronym / sponsor ID
- AALL04B2
- Conditions
- Childhood Acute Lymphoblastic Leukemia in Remission, Recurrent Childhood Acute Lymphoblastic Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 May 2004 (actual)
- Primary completion
- 5 May 2016 (actual)
- First posted
- 12 May 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 laboratory study is looking at DNA in tumor tissue samples from young patients with acute lymphoblastic leukemia. DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment
Detailed description
PRIMARY OBJECTIVE:
- To validate significant associations between SNPs and treatment outcome and toxicity on Children's Cancer Group (CCG)-1891 on an independent sample set from a successor CCG study for standard risk acute lymphoblastic leukemia (ALL), CCG-1952.
II. To evaluate the role of SNPs in drug metabolizing enzymes and the development of veno-occlusive disease in patients on CCG-1952.
III. To evaluate interactions among genotypes and other risk factors for treatment response in a combined data set of CCG-1891 and CCG-1952 with recently developed analytic tools for high dimensional data.
IV. To develop predictive models utilizing genetic information obtained in Aim 1.1 and clinical data to predict treatment response and toxicity.
OUTLINE:
Tumor tissue samples undergo genotype assessment on the Pyrosequencing platform. Contingency tables and X^2 test performs a univariate analysis of the risk of relapse and genotype, and multivariable analyses using logistic regression. Cox proportional hazards evaluate the risk of relapse given genotype and other confounders. Genotype patterning, classification and regression trees, and multifactor dimensionality reduction evaluates for patterns of single nucleotide polymorphisms associated with toxicity and relapse risk.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (genotype assessment) | – | Other: Laboratory Biomarker AnalysisTumor tissue samples undergo genotype assessment on the Pyrosequencing platform. Contingency tables and X^2 test performs a univariate analysis of the risk of relapse and genotype, and multivariable analyses using logistic regression. Cox proportional hazards evaluate the risk of relapse given genotype and other confounders. Genotype patterning, classification and regression trees, and multifactor dimensionality reduction evaluates for patterns of single nucleotide polymorphisms associated with toxicity and relapse risk. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Enrolled in clinical trial CCG-1891 or CCG-1952 with pediatric ALL
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 (genotype assessment) |
Primary outcome
Leukemia Relapse
Time frame: Day 7
Contingency tables will be used to tabulate the relationship between relapse and genotype, race, leukemia cytogenetics, day 7 bone marrow status, and treatment arm
Development of veno-occlusive disease in patients on CCG-1952
Time frame: Day 28
Classification and Regression Trees (CART), genotype patterning, Multifactor Dimensionality Reduction (MDR) techniques will be used to identify SNP combinations associated with risk of relapse and VOD
Development of a predictive model of leukemia relapse
Time frame: Day 28
Predictive models will be developed utilizing genetic information obtained in Aim 1.1 and clinical data to predict treatment response
Development of a predictive model of leukemia toxicity
Time frame: Day 28
Predictive models will be developed utilizing genetic information obtained in Aim 1.1 and clinical data to predict treatment toxicity.
1 secondary outcome
Development of grade III/IV toxicity as defined by the CCG toxicity criteria
Time frame: Day 28
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 15 Aug 2022.
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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.
Richard Aplenc 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 Lymphoblastic Leukemia in Remission and Recurrent Childhood Acute Lymphoblastic Leukemia, 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 1 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 15 Aug 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?
Leukemia Relapse (time frame: Day 7). The study lists 4 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 15 Aug 2022.