LeukemiaNCT00003861
Diagnostic Study of Patients With Acute Lymphoblastic Leukemia or Acute Promyelocytic Leukemia
An observational study of Leukemia and Acute Lymphoblastic Leukemia, run by Alliance for Clinical Trials in Oncology at 51 sites in United States.
Trial summary
This research trial studies molecular genetic features in blood and tissue samples from patients with newly diagnosed acute lymphoblastic leukemia or acute promyelocytic leukemia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leukemia, Acute Lymphoblastic Leukemia, Acute Promyelocytic Leukemia
- What is being tested?
- laboratory biomarker analysis
- How many people
- 840 participants
- Where
- 51 sitesUnited States
- Study dates
- Apr 1999to Jan 2100
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 enrolled on CALGB-19802, any CALGB treatment trial, SWOG-S0521, or SWOG-S0535
- Patients with a diagnosis of acute lymphoblastic leukemia (ALL) entered onto CALGB treatment trials for previously untreated ALL must be enrolled on CALGB 9862. Entry on CALGB 8461 is strongly encouraged.
- Patients with a diagnosis of acute promyelocytic leukemia (APL) enrolled on SWOG S0521 or S0535 must be enrolled on CALGB 9862.
Trial locations and contacts
51 sites in 1 country.
51 sites in 1 country
United States51 sites
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, 21201
CancerCare of Maine at Eastern Maine Medical Center
Bangor, Maine, 04401
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, 02115
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
University of Illinois Cancer Center
Chicago, Illinois, 60612-7243
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
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
Duke Cancer Institute
Durham, North Carolina, 27710
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, 13057
Union Hospital of Cecil County
Elkton, Maryland, 21921
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534
Leo W. Jenkins Cancer Center at ECU Medical School
Greenville, North Carolina, 27834
Cancer Centers of the Carolinas - Faris Road
Greenville, South Carolina, 29605
Cancer Centers of the Carolinas - Grove Commons
Greenville, South Carolina, 29605
Greenville Hospital Cancer Center
Greenville, South Carolina, 29605
CCOP - Greenville
Greenville, South Carolina, 29615
Cancer Centers of the Carolinas - Greer Medical Oncology
Greer, South Carolina, 29650
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1002
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
Kinston Medical Specialists
Kinston, North Carolina, 28501
Monter Cancer Center of the North Shore-LIJ Health System
Lake Success, New York, 11042
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, 19958
CCOP - North Shore University Hospital
Manhasset, New York, 11030
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, 11030
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
New York Weill Cornell Cancer Center at Cornell University
New York, New York, 10021
Mount Sinai Medical Center
New York, New York, 10029
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, 32803-1273
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224-1791
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, 02903
Miriam Hospital
Providence, Rhode Island, 02906
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298-0037
Naval Medical Center - San Diego
San Diego, California, 92134
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, 04074
Cancer Centers of the Carolinas - Seneca
Seneca, South Carolina, 29672
Cancer Centers of the Carolinas - Spartanburg
Spartanburg, South Carolina, 29307
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, 08043
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: Molecular Genetic Features of Acute Leukemia
This research trial studies molecular genetic features in blood and tissue samples from patients with newly diagnosed acute lymphoblastic leukemia or acute promyelocytic leukemia. Studying samples of blood and tissue from patients with acute lymphoblastic leukemia or acute promyelocytic leukemia in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
Read the detailed description
Objectives:
- To perform quantitative PCR using known leukemia specific markers in diagnostic bone marrow specimens of patients with newly diagnosed APL and ALL and to correlative pre-treatment copy number with other biologic and molecular features, clinical response, and treatment outcome.
- To evaluate the expression of novel genes or microRNAs implicated in disease pathogenesis and treatment response in pretreatment blood and bone marrow specimens of patients with APL and ALL and to correlate expression level with other biological features and treatment outcome.
- To evaluate the clinical significance of sequential quantitative MRD measurements using real-time quantitative PCR and/or flow cytometry during and following treatment of ALL and APL and correlate these findings with efficacy of novel treatment approaches and with other biological and clinical prognostic features.
- To compare measurement of MRD in blood with bone marrow specimens in sequential remission specimens of patients receiving treatment on ALL and APL treatment trials.
- Being tested
- laboratory biomarker analysis
- Medical subject headings
- Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Promyelocytic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-Correlative (molecular genetic features) | Previously collected blood and tissue samples are analyzed via RT-PCR and flow cytometry. Receives: Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Measured: At baseline
Overall survival
Measured: At baseline
Association of novel genes or micorRNAs with other biomarkers
Measured: At baseline
Secondary outcomes (2)
Clinical significance of minimal residual disease (MRD) as defined by BCR-ABL
Measured: At baseline
Clinical significance of MRD as defined by W T-1
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startApr 1999
- Primary completionJan 2100 (estimated)
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
- 840 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
- Wendy Stock, MD, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003861
- Sponsor's protocol ID
- CALGB-9862
- Other IDs
- U10CA076001, CALGB-9862, CDR0000067025
- Status last verified
- Aug 2023
- First submitted
- 1 Nov 1999
- Last updated
- 31 Aug 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Genetic Features of Acute Leukemia
- ClinicalTrials.gov ID
- NCT00003861
- Acronym / sponsor ID
- CALGB-9862
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 1999
- Primary completion
- Jan 2100 (estimated)
- First posted
- 27 Jan 2003 (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 trial studies molecular genetic features in blood and tissue samples from patients with newly diagnosed acute lymphoblastic leukemia or acute promyelocytic leukemia. Studying samples of blood and tissue from patients with acute lymphoblastic leukemia or acute promyelocytic leukemia in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
Detailed description
Objectives:
- To perform quantitative PCR using known leukemia specific markers in diagnostic bone marrow specimens of patients with newly diagnosed APL and ALL and to correlative pre-treatment copy number with other biologic and molecular features, clinical response, and treatment outcome.
- To evaluate the expression of novel genes or microRNAs implicated in disease pathogenesis and treatment response in pretreatment blood and bone marrow specimens of patients with APL and ALL and to correlate expression level with other biological features and treatment outcome.
- To evaluate the clinical significance of sequential quantitative MRD measurements using real-time quantitative PCR and/or flow cytometry during and following treatment of ALL and APL and correlate these findings with efficacy of novel treatment approaches and with other biological and clinical prognostic features.
- To compare measurement of MRD in blood with bone marrow specimens in sequential remission specimens of patients receiving treatment on ALL and APL treatment trials.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (molecular genetic features) | – | Other: laboratory biomarker analysisPreviously collected blood and tissue samples are analyzed via RT-PCR and flow cytometry. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients enrolled on CALGB-19802, any CALGB treatment trial, SWOG-S0521, or SWOG-S0535
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 analysis | Other | Ancillary-Correlative (molecular genetic features) |
Primary outcome
Disease-free survival
Time frame: At baseline
Overall survival
Time frame: At baseline
Association of novel genes or micorRNAs with other biomarkers
Time frame: At baseline
2 secondary outcomes
Clinical significance of minimal residual disease (MRD) as defined by BCR-ABL
Time frame: At baseline
Clinical significance of MRD as defined by W T-1
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
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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.
Wendy Stock, MD study chair
University of Chicago
51 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 and Acute Lymphoblastic Leukemia, run by Alliance for Clinical Trials in Oncology at 51 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: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 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?
This study is still under way. Results are not available in the source record yet.
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?
Disease-free survival (time frame: At baseline). 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 31 Aug 2023.