LeukemiaNCT01284010
Biomarkers in Blood and Bone Marrow Samples From Patients With Acute Lymphoblastic Leukemia
An observational study of Leukemia, run by Alliance for Clinical Trials in Oncology at 1 site in United States.
Trial summary
RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- DNA analysis, fluorescence in situ hybridization and gene expression analysis
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Sep 2014
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Acute lymphoblastic leukemia (ALL) patients treated on protocols CALGB 9511, 19802, 10001, 10102, and 10403, and who have been registered on the companion study CALGB 9665 (The CALGB Leukemia Tissue Bank)
Who may be able to join
- Diagnostic and germ-line specimens from patients with acute lymphoblastic leukemia (ALL) treated on protocols CALGB 9511, CALGB-19802, CALGB-10001, CALGB-10102, and CALGB-10403 and who have been registered on the companion study CALGB-9665 (The CALGB Leukemia Tissue Bank)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer and Leukemia Group B
Chicago, Illinois, 60606
About this study
Official title: Genome-Wide Analysis of Genetic Alterations in Adult Acute Lymphoblastic Leukemia
RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is studying biomarkers in blood and bone marrow samples from patients with acute lymphoblastic leukemia.
Read the detailed description
OBJECTIVES:
- To perform high-resolution, genome-wide profiling of DNA copy number alterations and loss-of-heterozygosity in samples from adult patients with acute lymphoblastic leukemia (ALL) obtained at diagnosis.
- To perform candidate gene resequencing of diagnostic ALL samples.
- To examine correlation of genetic alterations with outcome.
- To examine the correlation between microarray multi-gene and multi-exon expression signatures with specific alterations and outcome.
- To understand genetic events that contribute to the formation, development, and relapse of adult ALL by integrating the copy number and sequence alterations with the multi-gene signatures, and by comparing these data with data already generated in pediatric ALL.
OUTLINE: Diagnostic, complete remission, and germ-line specimens are analyzed for DNA profiling and gene resequencing by the Affymetrix SNP6.0 microarray platform, PCR, and fluorescence in situ hybridization (FISH). Frequency of genetic alterations are performed by the Agilent 2100 Bioanalyzer. Results are then compared with the data already generated from pediatric patients.
- Conditions
- Leukemia
- Being tested
- DNA analysis, fluorescence in situ hybridization, gene expression analysis, microarray analysis, mutation analysis
- Keywords
- adult acute lymphoblastic leukemia
- Medical subject headings
- Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA analysisGenetic
fluorescence in situ hybridizationGenetic
gene expression analysisGenetic
microarray analysisGenetic
mutation analysisGenetic
polymerase chain reactionGenetic
laboratory biomarker analysisOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Diagnostic, complete remission, and germ-line specimens are analyzed for DNA profiling and gene resequencing by the Affymetrix SNP6.0 microarray platform, PCR, and fluorescence in situ hybridization (FISH). Frequency of genetic alterations are performed by the Agilent 2100 Bioanalyzer. Results are then compared with the data already generated from pediatric patients. Receives: Genetic: DNA analysis; Genetic: fluorescence in situ hybridization; Genetic: gene expression analysis; Genetic: microarray analysis; Genetic: mutation analysis; Genetic: polymerase chain reaction; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete remission rate
Measured: Up to 7 Years
disease free survival
Measured: Up to 7 Years
cumulative incidence of relapse
Measured: Up to 7 years
overall survival
Measured: Up to 7 years
event-free survival
Measured: Up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe 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
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- James Downing, MD, Study chair, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284010
- Sponsor's protocol ID
- CALGB-21001
- Other IDs
- CALGB-21001, RC1CA145707, P30CA014236, CDR0000694150
- Status last verified
- Feb 2020
- First submitted
- 25 Jan 2011
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genome-Wide Analysis of Genetic Alterations in Adult Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT01284010
- Acronym / sponsor ID
- CALGB-21001
- Conditions
- Leukemia
- Keywords
- adult acute lymphoblastic leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 26 Jan 2011 (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.
RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is studying biomarkers in blood and bone marrow samples from patients with acute lymphoblastic leukemia.
Detailed description
OBJECTIVES:
- To perform high-resolution, genome-wide profiling of DNA copy number alterations and loss-of-heterozygosity in samples from adult patients with acute lymphoblastic leukemia (ALL) obtained at diagnosis.
- To perform candidate gene resequencing of diagnostic ALL samples.
- To examine correlation of genetic alterations with outcome.
- To examine the correlation between microarray multi-gene and multi-exon expression signatures with specific alterations and outcome.
- To understand genetic events that contribute to the formation, development, and relapse of adult ALL by integrating the copy number and sequence alterations with the multi-gene signatures, and by comparing these data with data already generated in pediatric ALL.
OUTLINE: Diagnostic, complete remission, and germ-line specimens are analyzed for DNA profiling and gene resequencing by the Affymetrix SNP6.0 microarray platform, PCR, and fluorescence in situ hybridization (FISH). Frequency of genetic alterations are performed by the Agilent 2100 Bioanalyzer. Results are then compared with the data already generated from pediatric patients.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Genetic: DNA analysis, Genetic: fluorescence in situ hybridization, Genetic: gene expression analysis, Genetic: microarray analysis, Genetic: mutation analysis, Genetic: polymerase chain reaction, Other: laboratory biomarker analysisDiagnostic, complete remission, and germ-line specimens are analyzed for DNA profiling and gene resequencing by the Affymetrix SNP6.0 microarray platform, PCR, and fluorescence in situ hybridization (FISH). Frequency of genetic alterations are performed by the Agilent 2100 Bioanalyzer. Results are then compared with the data already generated from pediatric patients. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Acute lymphoblastic leukemia (ALL) patients treated on protocols CALGB 9511, 19802, 10001, 10102, and 10403, and who have been registered on the companion study CALGB 9665 (The CALGB Leukemia Tissue Bank)
Key inclusion criteria (1 listed)
- Diagnostic and germ-line specimens from patients with acute lymphoblastic leukemia (ALL) treated on protocols CALGB 9511, CALGB-19802, CALGB-10001, CALGB-10102, and CALGB-10403 and who have been registered on the companion study CALGB-9665 (The CALGB Leukemia Tissue Bank)
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 |
|---|---|---|
| DNA analysis | Genetic | Group 1 |
| fluorescence in situ hybridization | Genetic | Group 1 |
| gene expression analysis | Genetic | Group 1 |
| microarray analysis | Genetic | Group 1 |
| mutation analysis | Genetic | Group 1 |
| polymerase chain reaction | Genetic | Group 1 |
| laboratory biomarker analysis | Other | Group 1 |
Primary outcome
complete remission rate
Time frame: Up to 7 Years
disease free survival
Time frame: Up to 7 Years
cumulative incidence of relapse
Time frame: Up to 7 years
overall survival
Time frame: Up to 7 years
event-free survival
Time frame: Up to 7 years
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 20 Feb 2020.
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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.
James Downing, MD study chair
St. Jude Children's Research Hospital
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 Leukemia, run by Alliance for Clinical Trials in Oncology 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 20 Feb 2020. 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?
complete remission rate (time frame: Up to 7 Years). The study lists 5 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 20 Feb 2020.