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LeukemiaNCT01004640

Study of Blood and Bone Marrow Samples in Patients With Chronic Myelogenous Leukemia Enrolled on a CALGB Clinical Trial

An observational study of Leukemia, run by Alliance for Clinical Trials in Oncology at 161 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Studying samples of blood and bone marrow from patients with cancer may help doctors identify biomarkers related to cancer. PURPOSE: This research study is looking at blood and bone marrow samples in patients with chronic myelogenous leukemia enrolled on a CALGB clinical trial. Read more about this study

Who is it for?
Any age
Conditions the study is for
Leukemia
What is being tested?
DNA analysis, Southern blotting and cytogenetic analysis
How many people
60 participants
Where
161 sitesUnited States
Study dates
15 Dec 1998to Feb 2001
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 ENTERED ONTO CALGB TREATMENT STUDIES FOR CML

Who may be able to join

  • Clinical diagnosis of chronic myelogenous leukemia (CML)
  • Concurrent enrollment on a CALGB treatment protocol for newly diagnosed or previously treated CML (e.g, CLB-19804)
  • Must not have initiated study therapy

Who cannot join

None listed.

Trial locations and contacts

161 sites in 1 country.

161 sites in 1 country

United States161 sites

  • Mission Hospital-Memorial Campus

    Asheville, North Carolina, 28801

  • Mission Hospital-Saint Joseph Campus

    Asheville, North Carolina, 28801

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • CancerCare of Maine at Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Eastern Maine Medical Center, Bangor

    Bangor, Maine, 04401

  • Central Vermont Medical Center/ National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61701

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • University of Vermont College of Medicine

    Burlington, Vermont, 05405

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Graham Hospital Assocation

    Canton, Illinois, 29605

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Physicians' Clinic of Iowa PC

    Cedar Rapids, Iowa, 52402

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Saint Luke's Hospital

    Cedar Rapids, Iowa, 54202

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Carolinas Medical Center, Charlotte

    Charlotte, North Carolina, 28203

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • Mount Sinai Hospital Medical Center

    Chicago, Illinois, 60608

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612-7243

  • Jesse Brown Veterans Affairs Medical Center

    Chicago, Illinois, 60612

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • Valley Regional

    Claremont, New Hampshire, 03743

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Veterans Administration

    Columbia, Missouri, 65201

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • University of Missouri - Ellis Fischel,

    Columbia, Missouri, 65212

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Greenville Health System Cancer Institute-Easley

    Easley, South Carolina, 29640

  • CCOP - Hematology-Oncology Associates of Central New York

    East Syracuse, New York, 13057

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Union Hospital Cancer Program at Union Hospital

    Elkton, Maryland, 21921

  • Elmhurst Hospital Center

    Elmhurst, New York, 11373

  • Eureka Hospital

    Eureka, Illinois, 61530

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 615330

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46845

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • Illinois CancerCare Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • Illinois CancerCare-Cottage

    Galesburg, Illinois, 61761

  • Glens Falls Hospital

    Glens Falls, New York, 12801

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Illinois Oncology Limited

    Granite City, Illinois, 62040

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Greenville Health System Cancer Institute-Andrews

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Butternut

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Faris

    Greenville, South Carolina, 29605

  • Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Eastside

    Greenville, South Carolina, 29615

  • Self Regional Healthcare

    Greenwood, South Carolina, 29646

  • Cancer Centers of the Carolinas-Green Medial Oncology

    Greer, South Carolina, 29650

  • Illinois CancerCare-Havana

    Havana, Illinois, 62644

  • Mason District Hospital

    Havana, Illinois, 62644

  • Memorial Healthcare System - Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021

  • Hopedale Medical Complex - Hospital, Hopedale

    Hopedale, Illinois, 61847

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1002

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Queens Hospital Center

    Jamaica, New York, 11432

  • Capital Regional Medical Center

    Jefferson City, Missouri, 65101

  • Jupiter Medical Center

    Jupiter, Florida, 33548

  • Cheshire Medical Center-Dartmouth-Hitchcock Keene

    Keene, New Hampshire, 03431

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Kewanee Hospital

    Kewanee, Illinois, 61443

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • Lenoir Memorial Hospital

    Kinston, North Carolina, 28501

  • Community Howard Regional Health

    Kokomo, Indiana, 46904

  • IU Health La Porte Hospital

    La Porte, Indiana, 46350

  • Weeks Memorial Hospital

    Lancaster, New Hampshire, 03584

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Nevada Cancer Research Foundation CCOP

    Las Vegas, Nevada, 89106

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Alice Peck Day Memorial Hospital

    Lebanon, New Hampshire, 03766

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Mcdonough District Hospital

    Macomb, Illinois, 61455

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Saint Joseph Regional Medical Center - Mishawaka

    Mishawaka, Indiana, 46545-1470

  • Holy Family Medical Center

    Monmouth, Illinois, 61462

  • Illinois CancerCare-Monmouth

    Monmouth, Illinois, 61462

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Weill Medical College of Cornell University

    New York, New York, 10065

  • Christiana Care Health Services

    Newark, Delaware, 19718

  • North Country Health

    Newport, Vermont, 05855

  • Community Cancer Center Foundation

    Normal, Illinois, 61761

  • Illinois CancerCare-Community Cancer Center

    Normal, Illinois, 61761

  • Bromenn Regional Medical Center

    Normal, Illinois, 61861

  • Oswego Hospital

    Oswego, New York, 13126

  • Illinois CancerCare- Ottawa Clinic

    Ottawa, Illinois, 61350

  • Ottwa Regional Hospital and Healthcare

    Ottawa, Illinois, 61350

  • Illinois CancerCare- Pekin

    Pekin, Illinois, 61554

  • Pekin Cancer Treatment Center

    Pekin, Illinois, 61554

  • Pekin Hospital

    Pekin, Illinois, 61554

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61603

  • Proctor Hospital

    Peoria, Illinois, 61614

  • Illinois CancerCare- Peoria

    Peoria, Illinois, 61615

  • Illinois Oncology Research Association-CCOP

    Peoria, Illinois, 61615

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois CancerCare- Peru

    Peru, Illinois, 61354

  • Illinois Valley Hospital

    Peru, Illinois, 61354

  • Valley Radiation Oncology

    Peru, Illinois, 61354

  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224-1791

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

  • Illinois CancerCare- Princeton

    Princeton, Illinois, 61356

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Frisbie Hospital

    Rochester, New Hampshire, 03867

  • Sarah Culberston Memorial Hospital

    Rushville, Illinois, 62681

  • Northeastern

    Saint Johnsbury, Vermont, 05819

  • Oncology Care Associates PLLC

    Saint Joseph, Michigan, 49085

  • Lakeland Hospital

    Saint Joseph, Missouri, 49085

  • Naval Medical Center - San Diego

    San Diego, California, 92134

  • UCSF Medical Center-Mount Zion

    San Francisco, California, 94115

  • Nanticoke Memorial Hospital

    Seaford, Delaware, 19973

  • Greenville Health System Cancer Institute-Seneca

    Seneca, South Carolina, 29672

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Northern Indiana Cancer Research Consrtium

    South Bend, Indiana, 46628

  • Greenville Health System Cancer Institute-Spartanburg

    Spartanburg, South Carolina, 29307

  • Illinois CancerCare- Spring Valley

    Spring Valley, Illinois, 61362

  • Saint Margaret's Hospital

    Spring Valley, Illinois, 61362

  • Springfield Hospital

    Springfield, Vermont, 05156

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Missouri Baptist Cancer Center

    St Louis, Missouri, 63131

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Arch Medical Services, Incorporated at Center for Cancer Care and Research

    St Louis, Missouri, 63141

  • Center for Cancer Care and Research

    St Louis, Missouri, 63141

  • Comprehensive Cancer Care, PC

    St Louis, Missouri, 63141

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Hematology Oncology Associates of Central New York-East Syracuse

    Syracuse, New York, 13057

  • Saint Joseph's Hospital Health Center

    Syracuse, New York, 13203

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • Syracuse Veterans Administration Medical Center

    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

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20057

  • White River Junction Veteran Administration Medical Center

    White River Junction, Vermont, 05009

  • Saint Francis Hospital - Wilmington

    Wilmington, Delaware, 19805

  • Wilson Medical Center

    Wilson, North Carolina, 27893

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1096

  • Commonwealth Hematology Oncology PC-Worcester, Worcester

    Worcester, Massachusetts, 01605

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: Molecular and Cytogenetic Monitoring of CML - A Mandatory Companion to CALGB 19804

RATIONALE: Studying samples of blood and bone marrow from patients with cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood and bone marrow samples in patients with chronic myelogenous leukemia enrolled on a CALGB clinical trial.

Read the detailed description

OBJECTIVES:

  • Monitor molecular response rates of patients receiving treatment for chronic myelogenous leukemia by quantitative reverse transcription polymerase chain reaction (RT-PCR) and quantitative Southern blot monitoring of blood samples.
  • Compare quantitative RT-PCR and quantitative Southern blot results with marrow cytogenetics at the time of complete molecular response in these patients.
  • Monitor the frequency of residual disease in patients who achieve a complete blood Southern blot and marrow cytogenetic response (eradication of BCR/ABL by Southern blot and absence of the Philadelphia chromosome by cytogenetics).

OUTLINE: Peripheral blood samples and bone marrow aspirates are collected at baseline and at 3, 6, and 9 months after starting therapy. If patient continues to receive protocol treatment after 9 months, additional peripheral blood samples are collected every 6 months and bone marrow aspirates are taken annually. In the event of disease progression (blast crisis), an additional peripheral blood sample and bone marrow aspirate are collected.

Samples are examined by quantitative Southern blot analysis with probes to BCR, quantitative reverse transcriptase-polymerase chain reaction analysis for BCR/ABL fusion transcripts, and cytogenetic analysis.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1.5 years.

Conditions
Leukemia
Being tested
DNA analysis, Southern blotting, cytogenetic analysis, polymerase chain reaction
Keywords
chronic myelogenous leukemia
Medical subject headings
Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DNA analysisGenetic

  • Southern blottingGenetic

  • cytogenetic analysisGenetic

    Also called Laboratory Biomarker Analysis

    Correlative studies

  • polymerase chain reactionGenetic

Study groups in NCT01004640
Study groupRoleWhat they receive
Group 1Peripheral blood samples and bone marrow aspirates are collected at baseline and at 3, 6, and 9 months after starting therapy. If patient continues to receive protocol treatment after 9 months, additional peripheral blood samples are collected every 6 months and bone marrow aspirates are taken annually. In the event of disease progression (blast crisis), an additional peripheral blood sample and bone marrow aspirate are collected. Samples are examined by quantitative Southern blot analysis with probes to BCR, quantitative reverse transcriptase-polymerase chain reaction analysis for BCR/ABL fusion transcripts, and cytogenetic analysis.
Receives: Genetic: DNA analysis; Genetic: Southern blotting; Genetic: cytogenetic analysis; Genetic: polymerase chain reaction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Distribution response

    Measured: Up to 1.5 years

  2. Distribution of cytogenetic response

    Measured: Up to 1.5 years

  3. Distribution of RT-PCR response or Southern blot response

    Measured: Up to 1.5 years

  4. Frequency of residual disease in patients who have achieved a complete response

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2009 (estimated)
  2. Study start15 Dec 1998
  3. Primary completionFeb 2001

Resources

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
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01004640
Sponsor's protocol ID
CALGB-29801
Other IDs
U10CA031946, U10CA180821, CDR0000078595
Status last verified
Sep 2023
First submitted
29 Oct 2009
Last updated
14 Sep 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Leukemia, run by Alliance for Clinical Trials in Oncology at 161 sites 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 3 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: status not confirmed, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 161 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?

Results are not available in the source record.

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?

Distribution response (time frame: Up to 1.5 years). 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?

On the ClinicalTrials.gov record for NCT01004640.

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 Sep 2023.

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