Combination Chemotherapy and Rituximab in Treating Patients with Untreated Burkitt Lymphoma

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IITreatment18 and over10-C-0052
NCI-2013-00915, 100052, CDR0000669336, 9177, NCT01092182

Trial Description

Summary

This phase II trial studies how well combination chemotherapy and rituximab works in treating patients with untreated Burkitt lymphoma. Drugs used in chemotherapy, such as etoposide, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may find cancer cells and trigger the immune system to attack them. Giving combination chemotherapy with rituximab may kill more cancer cells.

Further Study Information

PRIMARY OBJECTIVES:

I. Determine progression free survival (PFS), event free survival (EFS) and overall survival (OS) of risk adaptive dose-adjusted (DA)-etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (EPOCH)-with rituximab (R) in newly diagnosed Burkitt lymphoma, v-myc myelocytomatosis viral oncogene homolog (c-MYC)+ diffuse large B-cell lymphoma (DLBCL) and DA-EPOCH in c-MYC+ plasmablastic lymphoma >= 18 years.

SECONDARY OBJECTIVES:

I. Assess predictive value of early fludeoxyglucose F 18 (FDG)-positron emission tomography (PET)/computed tomography (CT) scans on PFS.

II. Obtain pilot comparative molecular profiling of human immunodeficiency virus (HIV) negative and positive Burkitt lymphoma (BL), c-MYC+ DLBCL and c-MYC+ plasmablastic lymphoma.

III. Assess the toxicity of risk adaptive DA-EPOCH-R in newly diagnosed Burkitt lymphoma, c-MYC+ DLBCL and DA-EPOCH in c-MYC+ plasmablastic lymphoma >= 18 years.

OUTLINE: Patients are assigned to 1 of 2 treatment groups.

GROUP I (LOW RISK PATIENTS): Patients receive rituximab intravenously (IV) on days 1 and 5; etoposide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV continuously over 96 hours on days 1-4; cyclophosphamide IV on day 5, and prednisone orally (PO) twice daily (BID) on days 1-5. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

GROUP II (HIGH RISK PATIENTS): Patients receive rituximab IV on day 1 and etoposide, doxorubicin hydrochloride, vincristine sulfate, cyclophosphamide, and prednisone as in Group I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. High risk patients who have achieved only a partial response at the completion of course 6 may receive up to 2 additional courses.

After completion of study treatment, patients are followed up periodically for at least 5 years.

Eligibility Criteria

Inclusion Criteria:

Patients must have Burkitt lymphoma; effective with Amendment J (version date: 06/24/2014), the following histologies were removed: B-cell lymphoma: unclassifiable with features intermediate between diffuse large B–cell lymphoma and Burkitt lymphoma; c-MYC + DLBCL and c-MYC+ plasmablastic lymphoma

If questions arise related to diagnosis, please contact the National Cancer Institute (NCI) principal investigator (PI), Dr. Dunleavy or the NCI study coordinator, A. Nicole Lucas

All disease stages

Pathology confirmed by treating institution’s pathology department

Eastern Cooperative Oncology Group (ECOG) 0-4

Ability of patient or durable power of attorney (DPA) for healthcare to give informed consent

No prior treatment except patients may be entered if they have had prior limited-field radiotherapy, a short course of glucocorticoids, cyclophosphamide for an urgent problem at diagnosis (e.g. epidural cord compression, superior vena cava syndrome) and/or a single dose of intrathecal methotrexate (MTX) at the time of the pre-treatment diagnostic lumbar puncture

HIV positive patients on antiretroviral therapy regimen must be willing to suspend all highly active antiretroviral therapy (HAART) except in circumstances described

Human immunodeficiency virus (HIV) negative or positive

Hepatitis B + patients may be enrolled at the discretion of the investigator

Exclusion Criteria:

Serious concomitant medical illnesses that would jeopardize the patient's ability to receive the regimen with reasonable safety

Serum creatinine (Cr) > 1.5 mg/dL or creatinine clearance < 50 ml/min/1.73 m^2 unless lymphoma related

History of a prior invasive malignancy in past 5 years

HIV positive patients with advanced immune suppression and evidence of HIV resistant to all combinations of antiretroviral therapy considered at high risk of non-lymphoma related death within 12-months due to other acquired immune deficiency syndrome (AIDS) complications should not be enrolled on the study

Female subject pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (b-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for women without child-bearing potential

Absolute neutrophil count (ANC) < 1000 unless lymphoma related

Patients with primary central nervous system (CNS) lymphoma

Bilirubin > 2 mg/dl (total) except > 5 mg/dl in patients with Gilbert’s syndrome as defined by > 80% unconjugated

Platelets < 75,000 unless lymphoma related

Female subject of child-bearing potential not willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and one year beyond treatment completion will not be eligible to participate in the study

Male subject unwilling to use an acceptable method for contraception for the duration of the study and one year beyond treatment completion, will not be eligible to participate in the study

Active symptomatic ischemic heart disease, myocardial infarction or congestive heart failure within the past year; if echocardiogram (ECHO) is obtained the left ventricular ejection fraction (LVEF) should exceed 40%

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

NCI - Center for Cancer Research

  • National Cancer Institute
Kieron Michael Dunleavy, Principal Investigator

Trial Sites

U.S.A.

California
Los Angeles

UCLA / Jonsson Comprehensive Cancer Center

Ronald T. Mitsuyasu
Ph: 888-798-0719

Ronald T. Mitsuyasu
Principal Investigator

UCLA Center for Clinical AIDS Research and Education

Ronald T. Mitsuyasu
Ph: 888-798-0719

Ronald T. Mitsuyasu
Principal Investigator

Illinois
Chicago

John H Stroger Jr Hospital of Cook County

Paul G. Rubinstein
Ph: 312-864-6000

Paul G. Rubinstein
Principal Investigator

Iowa
Iowa City

University of Iowa/Holden Comprehensive Cancer Center

Brian K. Link
Ph: 800-237-1225

Brian K. Link
Principal Investigator

Kansas
Overland Park

Menorah Medical Center

Rakesh Gaur
Ph: 816-932-2677
Email: SLCIResearch1@saint-lukes.org

Rakesh Gaur
Principal Investigator

Saint Luke's South Hospital

Rakesh Gaur
Ph: 816-932-2677
Email: SLCIResearch1@saint-lukes.org

Rakesh Gaur
Principal Investigator

Louisiana
Shreveport

Louisiana State University Health Sciences Center Shreveport

Srinivas Sankarnaga Devarakonda
Ph: 318-813-1412

Srinivas Sankarnaga Devarakonda
Principal Investigator

Maryland
Bethesda

National Institutes of Health

Kieron Michael Dunleavy
Ph: 800-411-1222

Kieron Michael Dunleavy
Principal Investigator

Massachusetts
Boston

Beth Israel Deaconess Medical Center

Ann Steward LaCasce
Ph: 877-442-3324

Ann Steward LaCasce
Principal Investigator

Dana-Farber Cancer Institute

Ann Steward LaCasce
Ph: 877-442-3324

Ann Steward LaCasce
Principal Investigator

Massachusetts General Hospital Cancer Center

Ann Steward LaCasce
Ph: 877-442-3324

Ann Steward LaCasce
Principal Investigator

Michigan
Kalamazoo

Borgess Medical Center

Raymond Sterling Lord
Ph: 269-373-7458

Raymond Sterling Lord
Principal Investigator

Bronson Methodist Hospital

Raymond Sterling Lord
Ph: 269-373-7458

Raymond Sterling Lord
Principal Investigator

West Michigan Cancer Center

Sunil Nagpal
Ph: 269-373-7458

Sunil Nagpal
Principal Investigator

Minnesota
Burnsville

Fairview Ridges Hospital

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Coon Rapids

Mercy Hospital

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Edina

Fairview-Southdale Hospital

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Fridley

Unity Hospital

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Hutchinson

Hutchinson Area Health Care

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Maplewood

Minnesota Oncology Hematology PA-Maplewood

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Saint John's Hospital - Healtheast

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Minneapolis

Abbott-Northwestern Hospital

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Hennepin County Medical Center

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Robbinsdale

North Memorial Medical Health Center

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Saint Louis Park

Park Nicollet Clinic - Saint Louis Park

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Saint Paul

Regions Hospital

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

United Hospital

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Shakopee

Saint Francis Regional Medical Center

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Waconia

Ridgeview Medical Center

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Willmar

Rice Memorial Hospital

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Woodbury

Minnesota Oncology and Hematology PA-Woodbury

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Missouri
Columbia

University of Missouri - Ellis Fischel

Clint Daniel Kingsley
Ph: 573-882-7440

Clint Daniel Kingsley
Principal Investigator

Kansas City

Heartland Hematology and Oncology Associates Incorporated

Rakesh Gaur
Ph: 816-932-2677
Email: SLCIResearch1@saint-lukes.org

Rakesh Gaur
Principal Investigator

Research Medical Center

Rakesh Gaur
Ph: 816-932-2677
Email: SLCIResearch1@saint-lukes.org

Rakesh Gaur
Principal Investigator

Saint Luke's Hospital of Kansas City

Rakesh Gaur
Ph: 816-932-2677
Email: SLCIResearch1@saint-lukes.org

Rakesh Gaur
Principal Investigator

Lee's Summit

Saint Luke's East - Lee's Summit

Rakesh Gaur
Ph: 816-932-2677
Email: SLCIResearch1@saint-lukes.org

Rakesh Gaur
Principal Investigator

Liberty

Liberty Radiation Oncology Center

Rakesh Gaur
Ph: 816-932-2677
Email: SLCIResearch1@saint-lukes.org

Rakesh Gaur
Principal Investigator

Saint Joseph

Heartland Regional Medical Center

Rakesh Gaur
Ph: 816-932-2677
Email: SLCIResearch1@saint-lukes.org

Rakesh Gaur
Principal Investigator

Saint Louis

Washington University School of Medicine

Nancy L. Bartlett
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Nancy L. Bartlett
Principal Investigator

Nebraska
Omaha

University of Nebraska Medical Center

Philip Jay Bierman
Ph: 402-559-6941
Email: unmcrsa@unmc.edu

Philip Jay Bierman
Principal Investigator

Nevada
Henderson

21st Century Oncology - Henderson

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Cancer and Blood Specialists-Henderson

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada - Henderson

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada-Southeast Henderson

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Las Vegas Cancer Center-Henderson

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Las Vegas

21st Century Oncology

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

21st Century Oncology - Fort Apache

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

21st Century Oncology - Vegas Tenaya

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Cancer and Blood Specialists-Fort Apache

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Cancer and Blood Specialists-Shadow

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Cancer and Blood Specialists-Tenaya

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Cancer Therapy and Integrative Medicine

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada - Central Valley

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada - Northwest

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada-Summerlin

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

HealthCare Partners Medical Group Oncology/Hematology-San Martin

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

HealthCare Partners Medical Group Oncology/Hematology-Tenaya

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Las Vegas Cancer Center-Medical Center

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Nevada Cancer Research Foundation CCOP

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Radiation Oncology Centers of Nevada Central

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Radiation Oncology Centers of Nevada Southeast

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

University Medical Center of Southern Nevada

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

New York
New York

Memorial Sloan-Kettering Cancer Center

Ariela Noy
Ph: 212-639-7202

Ariela Noy
Principal Investigator

Mount Sinai Medical Center

Samir Sunil Parekh
Ph: 212-824-7320
Email: jenny.figueroa@mssm.edu

Samir Sunil Parekh
Principal Investigator

Rochester

University of Rochester

Jonathan Willmann Friedberg
Ph: 585-275-5830

Jonathan Willmann Friedberg
Principal Investigator

North Carolina
Kinston

Kinston Medical Specialists PA

Peter Robins Watson
Ph: 252-559-2200

Peter Robins Watson
Principal Investigator

Winston-Salem

Wake Forest University Health Sciences

Zanetta S. Lamar
Ph: 336-713-6771

Zanetta S. Lamar
Principal Investigator

Ohio
Beachwood

Cleveland Clinic Cancer Center Beachwood

Anjali S. Advani
Ph: 866-223-8100

Anjali S. Advani
Principal Investigator

Cleveland

Cleveland Clinic Cancer Center/Fairview Hospital

Anjali S. Advani
Ph: 866-223-8100

Anjali S. Advani
Principal Investigator

Cleveland Clinic Foundation

Anjali S. Advani
Ph: 866-223-8100

Anjali S. Advani
Principal Investigator

MetroHealth Medical Center

Bruce J. Averbook
Ph: 216-778-8526
Email: kbauchens@metrohealth.org

Bruce J. Averbook
Principal Investigator

Independence

Cleveland Clinic Cancer Center Independence

Anjali S. Advani
Ph: 866-223-8100

Anjali S. Advani
Principal Investigator

Mansfield

Cleveland Clinic Cancer Center Mansfield

Anjali S. Advani
Ph: 866-223-8100

Anjali S. Advani
Principal Investigator

Mayfield Heights

Hillcrest Hospital Cancer Center

Anjali S. Advani
Ph: 866-223-8100

Anjali S. Advani
Principal Investigator

Sandusky

North Coast Cancer Care

Anjali S. Advani
Ph: 866-223-8100

Anjali S. Advani
Principal Investigator

Strongsville

Cleveland Clinic Cancer Center Strongsville

Anjali S. Advani
Ph: 866-223-8100

Anjali S. Advani
Principal Investigator

Warrensville Heights

South Pointe Hospital

Anjali S. Advani
Ph: 866-223-8100

Anjali S. Advani
Principal Investigator

Wooster

Cleveland Clinic Wooster Specialty Center

Anjali S. Advani
Ph: 866-223-8100

Anjali S. Advani
Principal Investigator

Pennsylvania
Philadelphia

Pennsylvania Hospital

Lee Hartner
Ph: 800-474-9892

Lee Hartner
Principal Investigator

Texas
Dallas

Parkland Memorial Hospital

Harris V. K. Naina
Ph: 214-648-7097

Harris V. K. Naina
Principal Investigator

UT Southwestern/Simmons Cancer Center-Dallas

Harris V. K. Naina
Ph: 214-648-7097

Harris V. K. Naina
Principal Investigator

Wisconsin
La Crosse

Gundersen Lutheran Medical Center

Kurt Oettel
Ph: 608-775-2385
Email: cancerctr@gundluth.org

Kurt Oettel
Principal Investigator

Madison

University of Wisconsin Hospital and Clinics

Julie E. Chang
Ph: 877-405-6866

Julie E. Chang
Principal Investigator

Milwaukee

Froedtert and the Medical College of Wisconsin

Timothy Sean Fenske
Ph: 414-805-4380

Timothy Sean Fenske
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01092182

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.