Study of Biomarkers in Blood and Bone Marrow Samples From Patients With Previously Untreated Chronic Lymphocytic Leukemia

NCT01005368 | Completed

• 2 other identifiers: CALGB-20203CDR0000398201
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 35

Brief 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 leukemia.

Conditions

Leukemia

Keywords

chronic lymphocytic leukemia

Outcome Measures

Primary Outcomes (3)

• complete response

  Up to 10 years

• prolonged progression-free survival

  Up to 10 years

• overall survival

  Up to 10 years

Study Arms (1)

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.

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

Interventions

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

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

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (35)

Kaiser Permanente Medical Office -Vandever Medical Office

San Diego, California, 92108, 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

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Louis A. Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46845, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1002, 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

National Naval Medical Center

Bethesda, Maryland, 20889-5600, United States

Location

Union Hospital of Cecil County

Elkton, Maryland, 21921, United States

Location

Veterans Affairs Medical Center - Minneapolis

Minneapolis, Minnesota, 55417, 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

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

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

CCOP - Hematology-Oncology Associates of Central New York

East Syracuse, New York, 13057, United States

Location

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, 28233-3549, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Pardee Memorial Hospital

Hendersonville, North Carolina, 28791, United States

Location

Kinston Medical Specialists

Kinston, North Carolina, 28501, 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

Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224-1791, United States

Location

McLeod Regional Medical Center

Florence, South Carolina, 29501, 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

Biospecimen

Retention: SAMPLES WITH DNA

blood and bone marrow samples

MeSH Terms

Conditions

Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

In Situ Hybridization, Fluorescence; Base Sequence; Polymerase Chain Reaction; Blotting, Western; Flow Cytometry

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

In Situ Hybridization; Staining and Labeling; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Cytogenetic Analysis; Genetic Techniques; Nucleic Acid Hybridization; Molecular Structure; Biochemical Phenomena; Chemical Phenomena; Genetic Structures; Genetic Phenomena; Nucleic Acid Amplification Techniques; Electrophoresis; Chemistry Techniques, Analytical; Electrochemical Techniques; Immunoblotting; Immunoassay; Immunologic Techniques; Molecular Probe Techniques; Cell Separation; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry

Study Officials

• John C. Byrd, MD

  Ohio State University Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2009
• First Posted: October 30, 2009
• Study Start: October 1, 2009
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Locations

US (35)