NCT00899223

Brief Summary

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.

Trial Health

73
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

142 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1996

Completed
13 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
15.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

28.6 years

First QC Date

May 9, 2009

Last Update Submit

July 30, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Collection and storage of specimens from newly diagnosed patients with acute or chronic leukemia or myelodysplastic syndromes enrolled on a CALGB protocol

    At diagnosis

  • Collection and storage of specimens from newly diagnosed patients with acute or chronic leukemia or myelodysplastic syndromes enrolled on a CALGB protocol

    At relapse

  • Collection and storage of specimens from newly diagnosed patients with acute or chronic leukemia or myelodysplastic syndromes enrolled on a CALGB protocol

    At remission

Study Arms (1)

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

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with leukemia or myelodysplasia.

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (142)

Camino Medical Group - Treatment Center

Mountain View, California, 94040, United States

Location

Unknown Facility

Pismo Beach, California, 93449, United States

Location

Naval Medical Center - San Diego

San Diego, California, 92134, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Helen and Harry Gray Cancer Center at Hartford Hospital

Hartford, Connecticut, 06102-5037, United States

Location

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Washington Cancer Institute at Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

Ella Milbank Foshay Cancer Center at Jupiter Medical Center

Jupiter, Florida, 33458, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Florida Hospital Cancer Institute at Florida Hospital Orlando

Orlando, Florida, 32803-1273, United States

Location

Illinois CancerCare - Bloomington

Bloomington, Illinois, 61701, United States

Location

St. Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Illinois CancerCare - Canton

Canton, Illinois, 61520, United States

Location

University of Illinois Cancer Center

Chicago, Illinois, 60612-7243, United States

Location

Veterans Affairs Medical Center - Chicago Westside Hospital

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Eureka Community Hospital

Eureka, Illinois, 61530, United States

Location

Illinois CancerCare - Eureka

Eureka, Illinois, 61530, United States

Location

Evanston Hospital

Evanston, Illinois, 60201-1781, United States

Location

Galesburg Clinic, PC

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare - Macomb

Macomb, Illinois, 61455, United States

Location

BroMenn Regional Medical Center

Normal, Illinois, 61761, United States

Location

Community Cancer Center

Normal, Illinois, 61761, United States

Location

Illinois CancerCare - Community Cancer Center

Normal, Illinois, 61761, United States

Location

Community Hospital of Ottawa

Ottawa, Illinois, 61350, United States

Location

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, 61350, United States

Location

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, 61554, United States

Location

Illinois CancerCare - Pekin

Pekin, Illinois, 61603, United States

Location

Proctor Hospital

Peoria, Illinois, 61614, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61615, United States

Location

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, 61615, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

OSF St. Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Illinois CancerCare - Peru

Peru, Illinois, 61354, United States

Location

Illinois Valley Community Hospital

Peru, Illinois, 61354, United States

Location

Illinois CancerCare - Spring Valley

Spring Valley, Illinois, 61362, United States

Location

Elkhart Clinic, LLC

Elkhart, Indiana, 46514-2098, United States

Location

Michiana Hematology-Oncology, PC - Elkhart

Elkhart, Indiana, 46514, United States

Location

Elkhart General Hospital

Elkhart, Indiana, 46515, United States

Location

Howard Community Hospital

Kokomo, Indiana, 46904, United States

Location

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, 46350, United States

Location

Suniti Medical Corporation

Merrillville, Indiana, 46410, United States

Location

Michiana Hematology-Oncology, PC - South Bend

Mishawaka, Indiana, 46545-1470, United States

Location

Saint Joseph Regional Medical Center

Mishawaka, Indiana, 46545-1470, United States

Location

Michiana Hematology Oncology PC - Plymouth

Plymouth, Indiana, 46563, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Michiana Hematology Oncology PC - La Porte

Westville, Indiana, 46391, United States

Location

Hematology Oncology Associates of the Quad Cities

Bettendorf, Iowa, 52722, United States

Location

Iowa Blood and Cancer Care

Cedar Rapids, Iowa, 52402, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1002, United States

Location

Veterans Affairs Medical Center - Iowa City

Iowa City, Iowa, 52246, United States

Location

Menorah Medical Center

Overland Park, Kansas, 66209, United States

Location

Saint Luke's Hospital - South

Overland Park, Kansas, 66213, United States

Location

CCOP - Kansas City

Prairie Village, Kansas, 66208, United States

Location

Harold Alfond Center for Cancer Care

Augusta, Maine, 04330, United States

Location

CancerCare of Maine at Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

National Naval Medical Center

Bethesda, Maryland, 20889-5600, United States

Location

Union Hospital of Cecil County

Elkton, Maryland, 21921, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber/Brigham and Women's Cancer Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Addison Gilbert Hospital

Gloucester, Massachusetts, 01930, United States

Location

Lakeland Regional Cancer Care Center - St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

Lakeside Cancer Specialists, PLLC

Saint Joseph, Michigan, 49085, United States

Location

St. Luke's Hospital Cancer Care Center

Duluth, Minnesota, 55805, United States

Location

Veterans Affairs Medical Center - Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Southeast Cancer Center

Cape Girardeau, Missouri, 63703, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

Goldschmidt Cancer Center

Jefferson City, Missouri, 65109, United States

Location

Saint Luke's Cancer Institute at Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

North Kansas City Hospital

Kansas City, Missouri, 64116, United States

Location

Heartland Hematology Oncology Associates, Incorporated

Kansas City, Missouri, 64118, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Saint Luke's East - Lee's Summit

Lee's Summit, Missouri, 64086, United States

Location

Saint Joseph Oncology, Incorporated

Saint Joseph, Missouri, 64507, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

Missouri Baptist Cancer Center

St Louis, Missouri, 63131, United States

Location

Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center

Grand Island, Nebraska, 68803, United States

Location

Callahan Cancer Center at Great Plains Regional Medical Center

North Platte, Nebraska, 69103, United States

Location

UNMC Eppley Cancer Center at the University of Nebraska Medical Center

Omaha, Nebraska, 68198-6805, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Sunrise Hospital and Medical Center

Las Vegas, Nevada, 89109, United States

Location

New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care

Concord, New Hampshire, 03301, United States

Location

New Hampshire Oncology - Hematology, PA - Hooksett

Hooksett, New Hampshire, 03106, United States

Location

Lakes Region General Hospital

Laconia, New Hampshire, 03246, United States

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Norris Cotton Cancer Center at Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

CCOP - Hematology-Oncology Associates of Central New York

East Syracuse, New York, 13057, United States

Location

Charles R. Wood Cancer Center at Glens Falls Hospital

Glens Falls, New York, 12801, United States

Location

Queens Cancer Center of Queens Hospital

Jamaica, New York, 11432, United States

Location

Monter Cancer Center of the North Shore-LIJ Health System

Lake Success, New York, 11042, United States

Location

CCOP - North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Don Monti Comprehensive Cancer Center at North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Veterans Affairs Medical Center - Syracuse

Syracuse, New York, 13210, United States

Location

Mission Hospitals - Memorial Campus

Asheville, North Carolina, 28801, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, 28233-3549, United States

Location

Batte Cancer Center at Northeast Medical Center

Concord, North Carolina, 28025, United States

Location

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Leo W. Jenkins Cancer Center at ECU Medical School

Greenville, North Carolina, 27834, United States

Location

Pardee Memorial Hospital

Hendersonville, North Carolina, 28791, United States

Location

Kinston Medical Specialists

Kinston, North Carolina, 28501, United States

Location

Cleveland Regional Medical Center

Shelby, North Carolina, 28150, United States

Location

Iredell Memorial Hospital

Statesville, North Carolina, 28677, United States

Location

Forsyth Regional Cancer Center at Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210-1240, United States

Location

Cancer Care Associates - Norman

Norman, Oklahoma, 73071, United States

Location

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Cancer Care Associates - Mercy Campus

Oklahoma City, Oklahoma, 73120, United States

Location

Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224-1791, United States

Location

Rhode Island Hospital Comprehensive Cancer Center

Providence, Rhode Island, 02903, United States

Location

Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

McLeod Regional Medical Center

Florence, South Carolina, 29501, United States

Location

Cancer Centers of the Carolinas - Faris Road

Greenville, South Carolina, 29605, United States

Location

Cancer Centers of the Carolinas - Grove Commons

Greenville, South Carolina, 29605, United States

Location

Greenville Hospital Cancer Center

Greenville, South Carolina, 29605, United States

Location

Cancer Centers of the Carolinas - Eastside

Greenville, South Carolina, 29615, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

Cancer Centers of the Carolinas - Greer Medical Oncology

Greer, South Carolina, 29650, United States

Location

Cancer Centers of the Carolinas - Seneca

Seneca, South Carolina, 29672, United States

Location

Cancer Centers of the Carolinas - Spartanburg

Spartanburg, South Carolina, 29307, United States

Location

Mountainview Medical

Berlin Corners, Vermont, 05602, United States

Location

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, 05401, United States

Location

Danville Regional Medical Center

Danville, Virginia, 24541, United States

Location

Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County

Martinsville, Virginia, 24115, United States

Location

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Related Publications (7)

  • Liu TH, Raval A, Chen SS, Matkovic JJ, Byrd JC, Plass C. CpG island methylation and expression of the secreted frizzled-related protein gene family in chronic lymphocytic leukemia. Cancer Res. 2006 Jan 15;66(2):653-8. doi: 10.1158/0008-5472.CAN-05-3712.

  • Archer KJ, Fu H, Mrozek K, Nicolet D, Mims AS, Uy GL, Stock W, Byrd JC, Hiddemann W, Braess J, Spiekermann K, Metzeler KH, Herold T, Eisfeld AK. Identifying long-term survivors and those at higher or lower risk of relapse among patients with cytogenetically normal acute myeloid leukemia using a high-dimensional mixture cure model. J Hematol Oncol. 2024 May 3;17(1):28. doi: 10.1186/s13045-024-01553-6.

  • Ozga M, Nicolet D, Mrozek K, Yilmaz AS, Kohlschmidt J, Larkin KT, Blachly JS, Oakes CC, Buss J, Walker CJ, Orwick S, Jurinovic V, Rothenberg-Thurley M, Dufour A, Schneider S, Sauerland MC, Gorlich D, Krug U, Berdel WE, Woermann BJ, Hiddemann W, Braess J, Subklewe M, Spiekermann K, Carroll AJ, Blum WG, Powell BL, Kolitz JE, Moore JO, Mayer RJ, Larson RA, Uy GL, Stock W, Metzeler KH, Grimes HL, Byrd JC, Salomonis N, Herold T, Mims AS, Eisfeld AK. Sex-associated differences in frequencies and prognostic impact of recurrent genetic alterations in adult acute myeloid leukemia (Alliance, AMLCG). Leukemia. 2024 Jan;38(1):45-57. doi: 10.1038/s41375-023-02068-8. Epub 2023 Nov 28.

  • Rebechi M, Kohlschmidt J, Mrozek K, Nicolet D, Mims AS, Blachly JS, Orwick S, Larkin KT, Oakes CC, Hantel A, Carroll AJ, Blum WG, Powell BL, Uy GL, Stone RM, Larson RA, Byrd JC, Paskett ED, Plascak JJ, Eisfeld AK. Association of social deprivation with survival in younger adult patients with AML: an Alliance study. Blood Adv. 2023 Aug 8;7(15):4019-4023. doi: 10.1182/bloodadvances.2022009325. No abstract available.

  • Mrozek K, Kohlschmidt J, Blachly JS, Nicolet D, Carroll AJ, Archer KJ, Mims AS, Larkin KT, Orwick S, Oakes CC, Kolitz JE, Powell BL, Blum WG, Marcucci G, Baer MR, Uy GL, Stock W, Byrd JC, Eisfeld AK. Outcome prediction by the 2022 European LeukemiaNet genetic-risk classification for adults with acute myeloid leukemia: an Alliance study. Leukemia. 2023 Apr;37(4):788-798. doi: 10.1038/s41375-023-01846-8. Epub 2023 Feb 23.

  • Fobare S, Kohlschmidt J, Ozer HG, Mrozek K, Nicolet D, Mims AS, Garzon R, Blachly JS, Orwick S, Carroll AJ, Stone RM, Wang ES, Kolitz JE, Powell BL, Oakes CC, Eisfeld AK, Hertlein E, Byrd JC. Molecular, clinical, and prognostic implications of PTPN11 mutations in acute myeloid leukemia. Blood Adv. 2022 Mar 8;6(5):1371-1380. doi: 10.1182/bloodadvances.2021006242.

  • Walker CJ, Kohlschmidt J, Eisfeld AK, Mrozek K, Liyanarachchi S, Song C, Nicolet D, Blachly JS, Bill M, Papaioannou D, Oakes CC, Giacopelli B, Genutis LK, Maharry SE, Orwick S, Archer KJ, Powell BL, Kolitz JE, Uy GL, Wang ES, Carroll AJ, Stone RM, Byrd JC, de la Chapelle A, Bloomfield CD. Genetic Characterization and Prognostic Relevance of Acquired Uniparental Disomies in Cytogenetically Normal Acute Myeloid Leukemia. Clin Cancer Res. 2019 Nov 1;25(21):6524-6531. doi: 10.1158/1078-0432.CCR-19-0725. Epub 2019 Aug 2.

Biospecimen

Retention: SAMPLES WITH DNA

* Bone Marrow Aspirate: 5 mL of bone marrow aspirate at the time of diagnosis, relapse, and during remission for each CALGB leukemia or myelodysplastic syndrome treatment protocol. * Blood: 10 mL of whole blood at the time of diagnosis, relapse, and during remission for each CALGB leukemia or myelodysplastic syndrome treatment protocol. * Buccal Cell Sample: One buccal cell sample at time of diagnosis, but may be obtained at other times if not done so previously

MeSH Terms

Conditions

Anemia, Refractory, with Excess of Blasts

Condition Hierarchy (Ancestors)

Anemia, RefractoryAnemiaHematologic DiseasesHemic and Lymphatic DiseasesMyelodysplastic SyndromesBone Marrow Diseases

Study Officials

  • Michael Caligiuri, MD

    Ohio State University Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

May 1, 1996

Primary Completion

December 1, 2024

Last Updated

July 31, 2024

Record last verified: 2024-07

Locations