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Nivolumab in Combination with Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma

Trial Status: Active

This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs 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. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.

Inclusion Criteria

  • Age >= 2 years
  • Patient must have histologically confirmed primary mediastinal B-cell lymphoma (PMBCL) as defined by World Health Organization (WHO) criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 or ECOG performance status of 3 if poor performance is related to lymphoma * Children's Oncology Group (COG) Institutions: Use Karnofsky for patients >= 17 and < 18 years of age and Lansky for patients < 17 years of age
  • Adults (age 18 or older): Creatinine clearance >= 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight
  • Pediatric Patients (age < 18 years): The following must have been obtained within 14 days prior to registration: * Measured or calculated (based on institutional standard) creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2, or * Serum creatinine =< 1.5 x institutional upper limit of normal (IULN), or a serum creatinine based on age/gender as follows: ** Age : 2 to < 6 year; Maximum serum creatinine (mg/dL): 0.8 (male; 0.8 (female) ** Age : 6 to < 10 years; Maximum serum creatinine (mg/dL): 1 (male); 1 (female) ** Age : 10 to < 13 years; Maximum serum creatinine (mg/dL): 1.2 (male); 1.2 (female) ** Age : 13 to < 16 years; Maximum serum creatinine (mg/dL): 1.5 (male); 1.4 (female) ** Age : >= 16 years to < 18 years; Maximum serum creatinine (mg/dL): 1.7 (male); 1.4 (female)
  • Patients with abnormal liver function will be eligible to enroll if the lab abnormality is thought to be due to the lymphoma or Gilbert’s syndrome
  • Age >= 18 years: Ejection fraction of >= 50% by echocardiogram
  • Age < 18 years: Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by radionuclide angiogram
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria

  • Administration of prior anti-cancer therapy except as outlined below: * A short course (=< 2 weeks) of corticosteroids for the relief of lymphoma-related symptoms * A single course of COP (cyclophosphamide, vincristine, and prednisone) * One cycle of chemo-immunotherapy including R-CHOP, DA-EPOCH-R, or a pediatric mature B-cell non-Hodgkin lymphoma (B-NHL) induction therapy (such as ANHL1131) that has not started more than 21 days prior to enrollment
  • Active ischemic heart disease or heart failure
  • Active uncontrolled infection
  • Central nervous system (CNS) involvement of lymphoma
  • Previous cancer that required systemic chemotherapy and/or thoracic radiation. Other cancers will be permitted if in remission x 3 years
  • Active autoimmune disease that has required systemic treatment (such as disease modifying agents, corticosteroids, or immunosuppressive agents) in the past 2 years. Replacement therapy such as thyroxine, insulin or physiologic corticosteroid for adrenal or pituitary insufficiency is not considered a form of systemic treatment
  • In patients < 18 years of age hepatitis B serologies consistent with past or current infections
  • Patients with severe hepatic impairment (Child-Pugh class C or serum total bilirubin > 5.0 mg/dL) unless thought to be due to lymphoma or Gilbert’s syndrome
  • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
  • Sexually active patients of reproductive potential who have not agreed to use a highly effective contraceptive method (failure rate of < 1% per year when used consistently and correctly) for the duration of their study participation
  • Lactating females are not eligible unless they have agreed not to breastfeed their infants starting with the first dose of study therapy and for at least 6 months after the last dose of rituximab

Alabama

Birmingham
Children's Hospital of Alabama
Status: ACTIVE
Contact: Site Public Contact
Phone: 205-638-9285
Mobile
USA Health Strada Patient Care Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-388-8721

Alaska

Anchorage
Providence Alaska Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871

Arizona

Mesa
Banner Children's at Desert
Status: ACTIVE
Contact: Site Public Contact
Phone: 480-412-3100
Tucson
Banner University Medical Center - Tucson
Status: ACTIVE
Contact: Site Public Contact

Arkansas

Little Rock
Arkansas Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 501-364-7373

California

Loma Linda
Loma Linda University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 909-558-4050
Los Angeles
Children's Hospital Los Angeles
Status: ACTIVE
Contact: Site Public Contact
Phone: 323-361-4110
Mattel Children's Hospital UCLA
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 310-825-6708
Madera
Valley Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 559-353-3000
Oakland
Kaiser Permanente-Oakland
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Orange
Children's Hospital of Orange County
Status: ACTIVE
Contact: Site Public Contact
Phone: 714-509-8646
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-827-8839
Palo Alto
Lucile Packard Children's Hospital Stanford University
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-694-0012
Sacramento
University of California Davis Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 916-734-3089
San Diego
Rady Children's Hospital - San Diego
Status: ACTIVE
Contact: Site Public Contact
Phone: 858-966-5934

Colorado

Aurora
Children's Hospital Colorado
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-764-5056
Denver
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-839-6000

Connecticut

Hartford
Connecticut Children's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 860-545-9981

Delaware

Wilmington
Alfred I duPont Hospital for Children
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-651-5572

District of Columbia

Washington
Children's National Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 202-884-2549
MedStar Georgetown University Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 202-444-2223

Florida

Fort Lauderdale
Broward Health Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-651-5572
Gainesville
University of Florida Health Science Center - Gainesville
Status: ACTIVE
Contact: Site Public Contact
Phone: 352-273-8010
Jacksonville
Nemours Children's Clinic-Jacksonville
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-651-5572
Orlando
Arnold Palmer Hospital for Children
Status: ACTIVE
Contact: Site Public Contact
Phone: 321-841-5357
Nemours Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-651-5572
Tampa
Saint Joseph's Hospital / Children's Hospital-Tampa
Status: ACTIVE
Contact: Site Public Contact
Phone: 813-357-0849

Georgia

Atlanta
Children's Healthcare of Atlanta - Egleston
Status: IN_REVIEW
Contact: Ryan Jameson Summers
Phone: 404-785-1200
Emory Proton Therapy Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-251-2854
Emory Saint Joseph's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-851-7115
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-778-1868
Emory University Hospital Midtown
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-946-7447
Savannah
Memorial Health University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 912-350-7887

Hawaii

Honolulu
Kapiolani Medical Center for Women and Children
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-983-6090

Idaho

Boise
Saint Luke's Cancer Institute - Boise
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774

Illinois

Chicago
Lurie Children's Hospital-Chicago
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-880-4562
University of Chicago Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-8222
University of Illinois
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-355-3046
Danville
Carle on Vermilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Effingham
Carle Physician Group-Effingham
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Maywood
Loyola University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 708-226-4357
Oak Lawn
Advocate Children's Hospital-Oak Lawn
Status: ACTIVE
Contact: Site Public Contact
Phone: 847-723-7570
Park Ridge
Advocate Children's Hospital-Park Ridge
Status: ACTIVE
Contact: Site Public Contact
Peoria
Saint Jude Midwest Affiliate
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-226-4343
Springfield
Southern Illinois University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-545-7929
Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532

Indiana

Indianapolis
Riley Hospital for Children
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-248-1199

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-237-1225

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 859-257-3379

Louisiana

New Orleans
Ochsner Medical Center Jefferson
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-842-8084

Maine

Bangor
Eastern Maine Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 207-973-4274
Scarborough
Maine Children's Cancer Program
Status: ACTIVE
Contact: Site Public Contact
Phone: 207-396-7581

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 410-955-8804

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-442-3324

Michigan

Ann Arbor
C S Mott Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-865-1125
East Lansing
Michigan State University Clinical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 517-975-9547
Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Royal Oak
Beaumont Children's Hospital-Royal Oak
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-551-7695

Minnesota

Edina
Fairview Southdale Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Minneapolis
Children's Hospitals and Clinics of Minnesota - Minneapolis
Status: ACTIVE
Contact: Site Public Contact
Phone: 612-813-5193
Saint Paul
United Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517

Mississippi

Jackson
University of Mississippi Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 601-815-6700

Missouri

Creve Coeur
Siteman Cancer Center at West County Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Kansas City
Children's Mercy Hospitals and Clinics
Status: ACTIVE
Contact: Site Public Contact
Phone: 816-302-6808
Email: rryan@cmh.edu
Saint Louis
Mercy Hospital Saint Louis
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-251-7066
Siteman Cancer Center-South County
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Washington University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606

Nebraska

Omaha
Children's Hospital and Medical Center of Omaha
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-955-3949
University of Nebraska Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-559-6941

Nevada

Las Vegas
Alliance for Childhood Diseases / Cure 4 the Kids Foundation
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Reno
Renown Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013

New Jersey

Hackensack
Hackensack University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 201-996-2879
Morristown
Morristown Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 973-971-5900
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: ACTIVE
Contact: Site Public Contact
Phone: 732-235-7356
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 732-235-8675
Paterson
Saint Joseph's Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 973-754-2207

New York

Albany
Albany Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 518-262-5513
Buffalo
Roswell Park Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-767-9355
New Hyde Park
The Steven and Alexandra Cohen Children's Medical Center of New York
Status: ACTIVE
Contact: Site Public Contact
Phone: 718-470-3460
New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-305-6361
NYP / Weill Cornell Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-746-1848
Rochester
University of Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-275-5830
Stony Brook
Stony Brook University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-862-2215
Syracuse
State University of New York Upstate Medical University
Status: ACTIVE
Contact: Site Public Contact
Phone: 315-464-5476
Uniondale
Memorial Sloan Kettering Nassau
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Valhalla
New York Medical College
Status: ACTIVE
Contact: Site Public Contact
Phone: 914-594-3794

North Carolina

Charlotte
Carolinas Medical Center / Levine Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-804-9376
Greenville
East Carolina University
Status: ACTIVE
Contact: Site Public Contact
Phone: 252-744-1015
Winston-Salem
Wake Forest University Health Sciences
Status: ACTIVE
Contact: Site Public Contact
Phone: 336-713-6771

North Dakota

Fargo
Sanford Broadway Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-323-5760

Ohio

Akron
Children's Hospital Medical Center of Akron
Status: ACTIVE
Contact: Site Public Contact
Phone: 330-543-3193
Cincinnati
Cincinnati Children's Hospital Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 513-636-2799
Cleveland
Cleveland Clinic Foundation
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Rainbow Babies and Childrens Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 216-844-5437
Columbus
Nationwide Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-722-6039
Dayton
Dayton Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-228-4055
Toledo
ProMedica Toledo Hospital / Russell J Ebeid Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 419-824-1842

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777

Oregon

Portland
Oregon Health and Science University
Status: APPROVED
Contact: Site Public Contact
Phone: 503-494-1080

Pennsylvania

Allentown
Lehigh Valley Hospital-Cedar Crest
Status: ACTIVE
Contact: Site Public Contact
Phone: 610-402-9543
Danville
Geisinger Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251
Hershey
Penn State Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 717-531-6012
Philadelphia
Children's Hospital of Philadelphia
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 267-425-5544
Pittsburgh
Children's Hospital of Pittsburgh of UPMC
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-692-8570

Puerto Rico

Caguas
HIMA San Pablo Oncologic Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 787-653-3434

Rhode Island

Providence
Rhode Island Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 401-444-1488

South Carolina

Columbia
Prisma Health Richland Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-241-6251
Greenville
BI-LO Charities Children's Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-241-6251
Prisma Health Cancer Institute - Eastside
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-241-6251
Saint Francis Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-603-6213
Saint Francis Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-603-6213

South Dakota

Sioux Falls
Sanford USD Medical Center - Sioux Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320

Tennessee

Knoxville
East Tennessee Childrens Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 865-541-8266
Memphis
Saint Jude Children's Research Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-226-4343
Nashville
The Children's Hospital at TriStar Centennial
Status: ACTIVE
Contact: Site Public Contact
Phone: 615-342-1919
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-811-8480

Texas

Amarillo
Texas Tech University Health Sciences Center-Amarillo
Status: ACTIVE
Contact: Site Public Contact
Phone: 806-354-5411
Austin
Dell Children's Medical Center of Central Texas
Status: ACTIVE
Contact: Site Public Contact
Phone: 512-628-1902
Dallas
Medical City Dallas Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 972-566-5588
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Site Public Contact
Phone: 214-648-7097
El Paso
El Paso Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 915-298-5444
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 713-798-1354
M D Anderson Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-632-6789
Lubbock
Covenant Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
UMC Cancer Center / UMC Health System
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 806-775-8590
San Antonio
Children's Hospital of San Antonio
Status: ACTIVE
Contact: Site Public Contact
Phone: 210-704-2894
University of Texas Health Science Center at San Antonio
Status: ACTIVE
Contact: Site Public Contact
Phone: 210-450-3800

Utah

Salt Lake City
Primary Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-585-5270

Virginia

Falls Church
Inova Fairfax Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 703-208-6650
Norfolk
Children's Hospital of The King's Daughters
Status: ACTIVE
Contact: Site Public Contact
Phone: 757-668-7243
Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Roanoke
Carilion Children's
Status: ACTIVE
Contact: Site Public Contact
Phone: 540-266-6238

Washington

Seattle
Seattle Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-987-2000
Spokane
Providence Sacred Heart Medical Center and Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-228-6618
Tacoma
Madigan Army Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 253-968-6144
Mary Bridge Children's Hospital and Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 253-403-1461

West Virginia

Charleston
West Virginia University Charleston Division
Status: ACTIVE
Contact: Site Public Contact
Phone: 304-388-9944

Wisconsin

Madison
University of Wisconsin Carbone Cancer Center
Status: APPROVED
Contact: Site Public Contact
Phone: 800-622-8922
Marshfield
Marshfield Medical Center-Marshfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581

Alberta

Edmonton
University of Alberta Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 780-407-8798

Manitoba

Winnipeg
CancerCare Manitoba
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-561-1026

Newfoundland and Labrador

Saint John's
Janeway Child Health Centre
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-722-1126

Nova Scotia

Halifax
IWK Health Centre
Status: ACTIVE
Contact: Site Public Contact
Phone: 902-470-8520

Ontario

Hamilton
McMaster Children's Hospital at Hamilton Health Sciences
Status: ACTIVE
Contact: Site Public Contact
Phone: 905-521-2100
London
Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 519-685-8306
Ottawa
Children's Hospital of Eastern Ontario
Status: ACTIVE
Contact: Site Public Contact
Phone: 613-737-7600
Toronto
Hospital for Sick Children
Status: ACTIVE
Contact: Site Public Contact
Phone: 416-813-7654

Quebec

Montreal
Centre Hospitalier Universitaire Sainte-Justine
Status: ACTIVE
Contact: Site Public Contact
Phone: 514-345-4931
The Montreal Children's Hospital of the MUHC
Status: ACTIVE
Contact: Site Public Contact
Phone: 514-412-4445

Australia

Hunter Regional Mail Centre
John Hunter Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: (02) 4985 5180
South Brisbane
Queensland Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 61 7 3068 1111
Westmead
The Children's Hospital at Westmead
Status: ACTIVE
Contact: Site Public Contact
Phone: 61-2-9845 1400

PRIMARY OBJECTIVE:

I. To determine if nivolumab + chemo-immunotherapy results in a superior long term progression-free survival (PFS) (events defined as disease progression confirmed by central review or death) when compared with chemo-immunotherapy alone in patients with newly diagnosed primary mediastinal B-cell lymphoma.

SECONDARY OBJECTIVES:

I. To compare the rates of “efficacy-related event-free survival (EFS)” (eEFS) (events defined as progression, change in therapy due to finding that led to concern about efficacy, biopsy + disease after 6 cycles of therapy, or death) between chemo-immunotherapy alone and chemo-immunotherapy + nivolumab in patients with newly diagnosed PMBCL.

II. To compare the rates of “therapy-related EFS” (tEFS) (events defined as relapse/progression, change in therapy for any reason, biopsy + disease after 6 cycles of therapy, secondary malignancy [SMN] or death) between chemo-immunotherapy alone and chemo-immunotherapy + nivolumab in patients with newly diagnosed PMBCL.

III. To compare the rates of overall survival (OS) between chemo-immunotherapy alone and chemo-immunotherapy + nivolumab in patients with newly diagnosed PMBCL.

IV. To establish the rate of a positive positron emission tomography (PET)-computed tomography (CT) (defined as Deauville score 4 or 5) at the completion of 6 cycles of nivolumab + rituximab (R)- cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP)/dose-adjusted (DA)-etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (EPOCH)-R and R-CHOP/DA-EPOCH-R in patients with newly diagnosed PMBCL and evaluate the prognostic significance of such a finding.

EXPLORATORY OBJECTIVES:

I. To bank radiology images for further studies.

II. To bank specimens for future correlative studies.

III. Characterize the immune profile of patients treated with nivolumab + chemo-immunotherapy to identify markers predictive of response.

IV. Define the rate of complete response at the completion of initial planned therapy.

OUTLINE: Patients are randomly assigned to backbone therapy or backbone therapy + nivolumab within each of 6 strata. The strata are determined by physician’s choice of backbone (DA-EPOCH-R vs. R-CHOP vs. R-CHOP + RT) and whether or not the patient had 1 prior cycle of therapy.

ARM A (DA-EPOCH-R): Patients receive prednisone or prednisolone orally (PO) once daily (QD) on days 1-5 and rituximab intravenously (IV) or rituximab and hyaluronidase human subcutaneously (SC) over 5 minutes on day 1 or 5. Patients also receive etoposide phosphate, doxorubicin hydrochloride, and vincristine sulfate IV over 96 hours on days 1-4 and cyclophosphamide IV over 30-60 minutes on day 5. Beginning 24-72 hours after completing cyclophosphamide, patients receive filgrastim or pegylated filgrastim SC daily until absolute neutrophil count (ANC) is >= 500/uL after the expected nadir. Treatment repeats every 21 days for up to 6 cycles (5 if the patient had 1 prior cycle of treatment) in the absence of disease progression or unacceptable toxicity.

ARM B (DA-EPOCH-R + NIVOLUMAB): Patients receive treatment as in Arm A. Patients also receive nivolumab IV over 30 minutes on day 1.

ARM C (R-CHOP): Patients receive prednisone or prednisolone PO QD on days 1-5 and rituximab IV or rituximab and hyaluronidase human SC over 5 minutes on day 1 or 5. Patients also receive cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV over 1-15 minutes or up to 60 minutes, and vincristine sulfate IV over 1 or up to 60 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (5 if the patient had 1 prior cycle of treatment) in the absence of disease progression or unacceptable toxicity.

ARM D (R-CHOP + NIVOLUMAB): Patients receive treatment as in Arm C. Patients also receive nivolumab IV over 30 minutes on day 1.

ARM E (R-CHOP + RADIOTHERAPY): Patients receive treatment as in Arm C. Within 6-8 weeks after completion of chemotherapy, patients undergo radiation therapy over 25 fractions.

ARM F (R-CHOP + RADIOTHERAPY + NIVOLUMAB): Patients receive treatment as in Arm D. Within 6-8 weeks after completion of chemotherapy, patients undergo radiation therapy over 25 fractions.

After completion of study treatment, patients are followed up every 3 months for year 1, every 6 months for years 2-3, and annually thereafter.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Children's Oncology Group

Principal Investigator
Lisa Giulino Roth

  • Primary ID ANHL1931
  • Secondary IDs NCI-2021-01071
  • Clinicaltrials.gov ID NCT04759586