LeukemiaNCT01005368
Study of Biomarkers in Blood and Bone Marrow Samples From Patients With Previously Untreated Chronic Lymphocytic Leukemia
An observational study of Leukemia, run by Alliance for Clinical Trials in Oncology at 35 sites in United States.
Trial summary
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This research study is looking at biomarkers in blood and bone marrow samples from patients with previously untreated chronic lymphocytic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leukemia
- What is being tested?
- fluorescence in situ hybridization, mutation analysis and nucleic acid sequencing
- How many people
- 600 participants
- Where
- 35 sitesUnited States
- Study dates
- Oct 2009to 1 Apr 2022
- 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
Study population: Patients diagnosed with chronic lymphocytic leukemia and were previously untreated. The patients must have also previously enrolled on a Cancer and Leukemia Group B protocol.
DISEASE CHARACTERISTICS:
- Diagnosis of chronic lymphocytic leukemia
- Previously untreated disease
- Registered to receive treatment on a Cancer and Leukemia Group B protocol
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330
CancerCare of Maine at Eastern Maine Medical Center
Bangor, Maine, 04401
Mountainview Medical
Berlin Corners, Vermont, 05602
National Naval Medical Center
Bethesda, Maryland, 20889-5600
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, 05401
Southeast Cancer Center
Cape Girardeau, Missouri, 63703
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, 28233-3549
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210-1240
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, 13057
Union Hospital of Cecil County
Elkton, Maryland, 21921
McLeod Regional Medical Center
Florence, South Carolina, 29501
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46845
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
Grand Island, Nebraska, 68803
Pardee Memorial Hospital
Hendersonville, North Carolina, 28791
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1002
Goldschmidt Cancer Center
Jefferson City, Missouri, 65109
Kinston Medical Specialists
Kinston, North Carolina, 28501
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, 19958
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
New York Weill Cornell Cancer Center at Cornell University
New York, New York, 10021
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
Callahan Cancer Center at Great Plains Regional Medical Center
North Platte, Nebraska, 69103
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, 68198-6805
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224-1791
Kaiser Permanente Medical Office -Vandever Medical Office
San Diego, California, 92108
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110
Missouri Baptist Cancer Center
St Louis, Missouri, 63131
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, 08043
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: Molecular Markers Of Chronic Lymphocytic Leukemia
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research study is looking at biomarkers in blood and bone marrow samples from patients with previously untreated chronic lymphocytic leukemia.
Read the detailed description
OBJECTIVES:
- Determine the relevance of common and uncommon interphase cytogenetic abnormalities related to baseline clinical features, complete response (CR), prolonged progression-free survival (PFS), and overall survival (OS) in patients with previously untreated chronic lymphocytic leukemia.
- Determine the significance of the absence of IgV_H gene mutational status as related to the ability to predict CR, PFS, and OS in these patients.
- Correlate IgV_H gene mutational status with CD38 expression, ZAP-70 expression, over-expression of Mcl-1, BAK-1, high Mcl-1:Bax ratio, p53 mutations or dysfunction, high-risk karyotype abnormalities, and other molecular features associated with poor outcome in these patients.
- Determine the prognostic significance of over-expression of Mcl-1, BAK-1, high Mcl-1:Bax ratio, p53 mutations or dysfunction, ATM mutation, ATM expression, and other factors that disrupt apoptosis with respect to CR, prolonged PFS, and OS.
- Determine if clonal evolution occurs in these biological markers at partial response or disease relapse.
OUTLINE: This is a multicenter study.
Blood and bone marrow is collected at baseline, 3 months after completion of induction therapy, 2 months after completion of consolidation therapy, 1 year after completion of study treatment, and at disease relapse. Samples are analyzed by FISH for interphase cytogenetics, PCR for IgV_H mutational status, flow cytometry for surface expression of CD38 cells, western blot to assess Mcl-1, Bcl-2, BAK-1, ATM, ZAP-70, and Bar expression, and sequencing for p53 and ATM function.
- Conditions
- Leukemia
- Being tested
- fluorescence in situ hybridization, mutation analysis, nucleic acid sequencing, polymerase chain reaction, western blotting
- Keywords
- chronic lymphocytic leukemia
- Medical subject headings
- Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorescence in situ hybridizationGenetic
mutation analysisGenetic
nucleic acid sequencingGenetic
polymerase chain reactionGenetic
western blottingGenetic
flow cytometryOther
laboratory biomarker analysisOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Blood and bone marrow is collected at baseline, 3 months after completion of induction therapy, 2 months after completion of consolidation therapy, 1 year after completion of study treatment, and at disease relapse. Samples are analyzed by FISH for interphase cytogenetics, PCR for IgV_H mutational status, flow cytometry for surface expression of CD38 cells, western blot to assess Mcl-1, Bcl-2, BAK-1, ATM, ZAP-70, and Bar expression, and sequencing for p53 and ATM function. Receives: Genetic: fluorescence in situ hybridization; Genetic: mutation analysis; Genetic: nucleic acid sequencing; Genetic: polymerase chain reaction; Genetic: western blotting; Other: flow cytometry; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response
Measured: Up to 10 years
prolonged progression-free survival
Measured: Up to 10 years
overall survival
Measured: Up to 10 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 startOct 2009
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
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
- Retrospective
- Enrolment
- 600 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
- John C. Byrd, MD, Study chair, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005368
- Sponsor's protocol ID
- CALGB-20203
- Other IDs
- CALGB-20203, CDR0000398201
- Status last verified
- Aug 2022
- First submitted
- 29 Oct 2009
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Markers Of Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT01005368
- Acronym / sponsor ID
- CALGB-20203
- Conditions
- Leukemia
- Keywords
- chronic lymphocytic leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2009 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (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.
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research study is looking at biomarkers in blood and bone marrow samples from patients with previously untreated chronic lymphocytic leukemia.
Detailed description
OBJECTIVES:
- Determine the relevance of common and uncommon interphase cytogenetic abnormalities related to baseline clinical features, complete response (CR), prolonged progression-free survival (PFS), and overall survival (OS) in patients with previously untreated chronic lymphocytic leukemia.
- Determine the significance of the absence of IgV_H gene mutational status as related to the ability to predict CR, PFS, and OS in these patients.
- Correlate IgV_H gene mutational status with CD38 expression, ZAP-70 expression, over-expression of Mcl-1, BAK-1, high Mcl-1:Bax ratio, p53 mutations or dysfunction, high-risk karyotype abnormalities, and other molecular features associated with poor outcome in these patients.
- Determine the prognostic significance of over-expression of Mcl-1, BAK-1, high Mcl-1:Bax ratio, p53 mutations or dysfunction, ATM mutation, ATM expression, and other factors that disrupt apoptosis with respect to CR, prolonged PFS, and OS.
- Determine if clonal evolution occurs in these biological markers at partial response or disease relapse.
OUTLINE: This is a multicenter study.
Blood and bone marrow is collected at baseline, 3 months after completion of induction therapy, 2 months after completion of consolidation therapy, 1 year after completion of study treatment, and at disease relapse. Samples are analyzed by FISH for interphase cytogenetics, PCR for IgV_H mutational status, flow cytometry for surface expression of CD38 cells, western blot to assess Mcl-1, Bcl-2, BAK-1, ATM, ZAP-70, and Bar expression, and sequencing for p53 and ATM function.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Genetic: fluorescence in situ hybridization, Genetic: mutation analysis, Genetic: nucleic acid sequencing, Genetic: polymerase chain reaction, Genetic: western blotting, Other: flow cytometry, Other: laboratory biomarker analysisBlood and bone marrow is collected at baseline, 3 months after completion of induction therapy, 2 months after completion of consolidation therapy, 1 year after completion of study treatment, and at disease relapse. Samples are analyzed by FISH for interphase cytogenetics, PCR for IgV_H mutational status, flow cytometry for surface expression of CD38 cells, western blot to assess Mcl-1, Bcl-2, BAK-1, ATM, ZAP-70, and Bar expression, and sequencing for p53 and ATM function. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with chronic lymphocytic leukemia and were previously untreated. The patients must have also previously enrolled on a Cancer and Leukemia Group B protocol.
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 |
|---|---|---|
| fluorescence in situ hybridization | Genetic | Group 1 |
| mutation analysis | Genetic | Group 1 |
| nucleic acid sequencing | Genetic | Group 1 |
| polymerase chain reaction | Genetic | Group 1 |
| western blotting | Genetic | Group 1 |
| flow cytometry | Other | Group 1 |
| laboratory biomarker analysis | Other | Group 1 |
Primary outcome
complete response
Time frame: Up to 10 years
prolonged progression-free survival
Time frame: Up to 10 years
overall survival
Time frame: Up to 10 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 3 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.
John C. Byrd, MD study chair
Ohio State University Comprehensive Cancer Center
35 sites 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 35 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 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 35 sites 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 response (time frame: Up to 10 years). The study lists 3 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 3 Aug 2022.