Collecting and Storing Blood, Bone Marrow, and Other Samples From Patients With Acute Leukemia, Chronic Leukemia, or Myelodysplastic Syndromes

July 30, 2024 updated by: Alliance for Clinical Trials in Oncology

The CALGB Leukemia Tissue Bank

As one of the nation's largest cooperative cancer treatment groups, the Alliance for Clinical Trials in Oncology (Alliance) is in a unique position to organize a Leukemia Tissue Bank. The member institutions diagnose hundreds of patients with leukemia or myelodysplastic syndrome each year, and uniformly treat these patients with chemotherapy regimens. The Alliance offers centralized data management for the clinical history, the classification of the leukemia and myelodysplastic syndrome, cytogenetics, flow cytometric analysis, treatment and follow-up. The highly skilled health care providers at each member institution are familiar with obtaining informed consent, completing data questionnaires and shipping specimens. There currently exists a central processing facility where samples are prepared for a variety of cellular and molecular studies. Hence, the patient resources, the health care providers, and a processing facility for a Leukemia Tissue Bank are all in place. What is needed, however, and is addressed in the current protocol, is a formal mechanism to procure bone marrow, blood and normal tissue from patients with hematologic malignancies who are to be enrolled on Alliance (Cancer and Leukemia Group B [CALGB]) treatment studies.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of the study is to collect and store specimens from every newly diagnosed patient with acute or chronic leukemia or myelodysplastic syndrome (MDS) who are entered on a CALGB protocol for previously untreated patients. Bone marrow aspirate and blood specimens are obtained from patients at diagnosis, remission, or relapse and stored. Buccal smears are obtained at diagnosis, and DNA is extracted and preserved.

It was anticipated that the specimens collected under this protocol would be used by a large number of investigators. This protocol does not describe the details of each approved project (eg, eligibility age range).

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Mountain View, California, United States, 94040
        • Camino Medical Group - Treatment Center
      • Pismo Beach, California, United States, 93449
      • San Diego, California, United States, 92134
        • Naval Medical Center - San Diego
      • San Francisco, California, United States, 94115
        • UCSF Helen Diller Family Comprehensive Cancer Center
    • Connecticut
      • Hartford, Connecticut, United States, 06102-5037
        • Helen and Harry Gray Cancer Center at Hartford Hospital
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Tunnell Cancer Center at Beebe Medical Center
      • Newark, Delaware, United States, 19713
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
      • Washington, District of Columbia, United States, 20010
        • Washington Cancer Institute at Washington Hospital Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
      • Jupiter, Florida, United States, 33458
        • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
      • Miami Beach, Florida, United States, 33140
        • CCOP - Mount Sinai Medical Center
      • Orlando, Florida, United States, 32803-1273
        • Florida Hospital Cancer Institute at Florida Hospital Orlando
    • Illinois
      • Bloomington, Illinois, United States, 61701
        • Illinois CancerCare - Bloomington
      • Bloomington, Illinois, United States, 61701
        • St. Joseph Medical Center
      • Canton, Illinois, United States, 61520
        • Illinois CancerCare - Canton
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, United States, 60612-7243
        • University of Illinois Cancer Center
      • Chicago, Illinois, United States, 60612
        • Veterans Affairs Medical Center - Chicago Westside Hospital
      • Eureka, Illinois, United States, 61530
        • Illinois CancerCare - Eureka
      • Eureka, Illinois, United States, 61530
        • Eureka Community Hospital
      • Evanston, Illinois, United States, 60201-1781
        • Evanston Hospital
      • Galesburg, Illinois, United States, 61401
        • Galesburg Clinic, PC
      • Macomb, Illinois, United States, 61455
        • Illinois CancerCare - Macomb
      • Normal, Illinois, United States, 61761
        • Bromenn Regional Medical Center
      • Normal, Illinois, United States, 61761
        • Community Cancer Center
      • Normal, Illinois, United States, 61761
        • Illinois CancerCare - Community Cancer Center
      • Ottawa, Illinois, United States, 61350
        • Community Hospital of Ottawa
      • Ottawa, Illinois, United States, 61350
        • Oncology Hematology Associates of Central Illinois, PC - Ottawa
      • Pekin, Illinois, United States, 61554
        • Cancer Treatment Center at Pekin Hospital
      • Pekin, Illinois, United States, 61603
        • Illinois CancerCare - Pekin
      • Peoria, Illinois, United States, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, United States, 61614
        • Proctor Hospital
      • Peoria, Illinois, United States, 61637
        • OSF St. Francis Medical Center
      • Peoria, Illinois, United States, 61615
        • CCOP - Illinois Oncology Research Association
      • Peoria, Illinois, United States, 61615
        • Oncology Hematology Associates of Central Illinois, PC - Peoria
      • Peru, Illinois, United States, 61354
        • Illinois CancerCare - Peru
      • Peru, Illinois, United States, 61354
        • Illinois Valley Community Hospital
      • Spring Valley, Illinois, United States, 61362
        • Illinois CancerCare - Spring Valley
    • Indiana
      • Elkhart, Indiana, United States, 46515
        • Elkhart General Hospital
      • Elkhart, Indiana, United States, 46514-2098
        • Elkhart Clinic, LLC
      • Elkhart, Indiana, United States, 46514
        • Michiana Hematology-Oncology, PC - Elkhart
      • Kokomo, Indiana, United States, 46904
        • Howard Community Hospital
      • La Porte, Indiana, United States, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • Merrillville, Indiana, United States, 46410
        • Suniti Medical Corporation
      • Mishawaka, Indiana, United States, 46545-1470
        • Michiana Hematology-Oncology, PC - South Bend
      • Mishawaka, Indiana, United States, 46545-1470
        • Saint Joseph Regional Medical Center
      • Plymouth, Indiana, United States, 46563
        • Michiana Hematology Oncology PC - Plymouth
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, United States, 46601
        • CCOP - Northern Indiana CR Consortium
      • Westville, Indiana, United States, 46391
        • Michiana Hematology Oncology PC - La Porte
    • Iowa
      • Bettendorf, Iowa, United States, 52722
        • Hematology Oncology Associates of the Quad Cities
      • Cedar Rapids, Iowa, United States, 52402
        • Iowa Blood and Cancer Care
      • Iowa City, Iowa, United States, 52242-1002
        • Holden Comprehensive Cancer Center at University of Iowa
      • Iowa City, Iowa, United States, 52246
        • Veterans Affairs Medical Center - Iowa City
    • Kansas
      • Overland Park, Kansas, United States, 66209
        • Menorah Medical Center
      • Overland Park, Kansas, United States, 66213
        • Saint Luke's Hospital - South
      • Prairie Village, Kansas, United States, 66208
        • CCOP - Kansas City
    • Maine
      • Augusta, Maine, United States, 04330
        • Harold Alfond Center for Cancer Care
      • Bangor, Maine, United States, 04401
        • CancerCare of Maine at Eastern Maine Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Greenebaum Cancer Center at University of Maryland Medical Center
      • Bethesda, Maryland, United States, 20889-5600
        • National Naval Medical Center
      • Elkton, Maryland, United States, 21921
        • Union Hospital of Cecil County
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber/Brigham and Women's Cancer Center
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
      • Gloucester, Massachusetts, United States, 01930
        • Addison Gilbert Hospital
    • Michigan
      • Saint Joseph, Michigan, United States, 49085
        • Lakeside Cancer Specialists, PLLC
      • Saint Joseph, Michigan, United States, 49085
        • Lakeland Regional Cancer Care Center - St. Joseph
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • St. Luke's Hospital Cancer Care Center
      • Minneapolis, Minnesota, United States, 55417
        • Veterans Affairs Medical Center - Minneapolis
      • Minneapolis, Minnesota, United States, 55455
        • Masonic Cancer Center at University of Minnesota
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Southeast Cancer Center
      • Columbia, Missouri, United States, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Jefferson City, Missouri, United States, 65109
        • Goldschmidt Cancer Center
      • Kansas City, Missouri, United States, 64116
        • North Kansas City Hospital
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Cancer Institute at Saint Luke's Hospital
      • Kansas City, Missouri, United States, 64118
        • Heartland Hematology Oncology Associates, Incorporated
      • Lee's Summit, Missouri, United States, 64086
        • Saint Luke's East - Lee's Summit
      • Saint Joseph, Missouri, United States, 64507
        • Saint Joseph Oncology, Incorporated
      • Saint Louis, Missouri, United States, 63131
        • Missouri Baptist Cancer Center
      • Saint Louis, Missouri, United States, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
      • North Platte, Nebraska, United States, 69103
        • Callahan Cancer Center at Great Plains Regional Medical Center
      • Omaha, Nebraska, United States, 68198-6805
        • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Sunrise Hospital and Medical Center
      • Las Vegas, Nevada, United States, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, United States, 89106
        • CCOP - Nevada Cancer Research Foundation
    • New Hampshire
      • Concord, New Hampshire, United States, 03301
        • New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
      • Hooksett, New Hampshire, United States, 03106
        • New Hampshire Oncology - Hematology, PA - Hooksett
      • Laconia, New Hampshire, United States, 03246
        • Lakes Region General Hospital
      • Lebanon, New Hampshire, United States, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
      • Manchester, New Hampshire, United States, 03102
        • Norris Cotton Cancer Center at Catholic Medical Center
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Cancer Institute of New Jersey at Cooper - Voorhees
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute
      • East Syracuse, New York, United States, 13057
        • CCOP - Hematology-Oncology Associates of Central New York
      • Glens Falls, New York, United States, 12801
        • Charles R. Wood Cancer Center at Glens Falls Hospital
      • Jamaica, New York, United States, 11432
        • Queens Cancer Center of Queens Hospital
      • Lake Success, New York, United States, 11042
        • Monter Cancer Center of the North Shore-LIJ Health System
      • Manhasset, New York, United States, 11030
        • CCOP - North Shore University Hospital
      • Manhasset, New York, United States, 11030
        • Don Monti Comprehensive Cancer Center at North Shore University Hospital
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center
      • New York, New York, United States, 10021
        • New York Weill Cornell Cancer Center at Cornell University
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
      • Syracuse, New York, United States, 13210
        • Veterans Affairs Medical Center - Syracuse
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University Hospital
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mission Hospitals - Memorial Campus
      • Chapel Hill, North Carolina, United States, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Charlotte, North Carolina, United States, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Charlotte, North Carolina, United States, 28233-3549
        • Presbyterian Cancer Center at Presbyterian Hospital
      • Concord, North Carolina, United States, 28025
        • Batte Cancer Center at Northeast Medical Center
      • Durham, North Carolina, United States, 27710
        • Duke Cancer Institute
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Memorial Hospital, Incorporated
      • Greenville, North Carolina, United States, 27834
        • Leo W. Jenkins Cancer Center at ECU Medical School
      • Hendersonville, North Carolina, United States, 28791
        • Pardee Memorial Hospital
      • Kinston, North Carolina, United States, 28501
        • Kinston Medical Specialists
      • Shelby, North Carolina, United States, 28150
        • Cleveland Regional Medical Center
      • Statesville, North Carolina, United States, 28677
        • Iredell Memorial Hospital
      • Winston-Salem, North Carolina, United States, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
      • Winston-Salem, North Carolina, United States, 27103
        • Forsyth Regional Cancer Center at Forsyth Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43210-1240
        • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
        • Cancer Care Associates - Norman
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Cancer Institute
      • Oklahoma City, Oklahoma, United States, 73120
        • Cancer Care Associates - Mercy Campus
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224-1791
        • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Miriam Hospital
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital Comprehensive Cancer Center
    • South Carolina
      • Florence, South Carolina, United States, 29501
        • McLeod Regional Medical Center
      • Greenville, South Carolina, United States, 29615
        • CCOP - Greenville
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital Cancer Center
      • Greenville, South Carolina, United States, 29615
        • Cancer Centers of the Carolinas - Eastside
      • Greenville, South Carolina, United States, 29605
        • Cancer Centers of the Carolinas - Faris Road
      • Greenville, South Carolina, United States, 29605
        • Cancer Centers of the Carolinas - Grove Commons
      • Greer, South Carolina, United States, 29650
        • Cancer Centers of the Carolinas - Greer Medical Oncology
      • Seneca, South Carolina, United States, 29672
        • Cancer Centers of the Carolinas - Seneca
      • Spartanburg, South Carolina, United States, 29307
        • Cancer Centers of the Carolinas - Spartanburg
    • Vermont
      • Berlin, Vermont, United States, 05602
        • Mountainview Medical
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care - University Health Center Campus
    • Virginia
      • Danville, Virginia, United States, 24541
        • Danville Regional Medical Center
      • Martinsville, Virginia, United States, 24115
        • Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
      • Richmond, Virginia, United States, 23298-0037
        • Virginia Commonwealth University Massey Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with leukemia or myelodysplasia.

Description

  • Previously untreated patients on a CALGB treatment protocol for leukemia (acute or chronic) or myelodysplasia are eligible. Patients must be registered to CALGB 9665 prior to receiving any therapy for their disease.
  • Signed informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Previously untreated patients on a CALGB treatment protocol for leukemia (acute or chronic) or myelodysplasia are eligible. Patients must be registered to CALGB 9665 prior to receiving any therapy for their disease.
Other: biologic sample preservation procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Collection and storage of specimens from newly diagnosed patients with acute or chronic leukemia or myelodysplastic syndromes enrolled on a CALGB protocol
Time Frame: At diagnosis
At diagnosis
Collection and storage of specimens from newly diagnosed patients with acute or chronic leukemia or myelodysplastic syndromes enrolled on a CALGB protocol
Time Frame: At relapse
At relapse
Collection and storage of specimens from newly diagnosed patients with acute or chronic leukemia or myelodysplastic syndromes enrolled on a CALGB protocol
Time Frame: At remission
At remission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Michael Caligiuri, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 1996

Primary Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimated)

May 12, 2009

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALGB-9665
  • U10CA031946 (U.S. NIH Grant/Contract)
  • CDR0000271412 (Registry Identifier: NCI Physician Data Query)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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