Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 5-10 and 20-25 for adults or days 4-9 for pediatric patients. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician.

Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 5-10 and 20-25 for adults or days 4-9 for pediatric patients. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician.

Ann Arbor Stage III Hodgkin Lymphoma

Ann Arbor Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma

Ann Arbor Stage III Mixed Cellularity Classic Hodgkin Lymphoma

Ann Arbor Stage III Nodular Sclerosis Classic Hodgkin Lymphoma

Ann Arbor Stage IIIA Hodgkin Lymphoma

Ann Arbor Stage IIIB Hodgkin Lymphoma

Ann Arbor Stage IV Hodgkin Lymphoma

Ann Arbor Stage IV Lymphocyte-Depleted Classic Hodgkin Lymphoma

Ann Arbor Stage IV Mixed Cellularity Classic Hodgkin Lymphoma

Ann Arbor Stage IV Nodular Sclerosis Classic Hodgkin Lymphoma

Ann Arbor Stage IVA Hodgkin Lymphoma

Ann Arbor Stage IVB Hodgkin Lymphoma

Classic Hodgkin Lymphoma

Lymphocyte-Rich Classic Hodgkin Lymphoma

Brentuximab Vedotin

Dacarbazine

Doxorubicin

Doxorubicin Hydrochloride

Filgrastim

Nivolumab

Pegfilgrastim

Quality-of-Life Assessment

Questionnaire Administration

Radiation Therapy

Vinblastine

Vinblastine Sulfate

Children's Hospital of Alabama

University of Alabama at Birmingham Cancer Center

USA Health Strada Patient Care Center

Anchorage Associates in Radiation Medicine

Alaska Breast Care and Surgery LLC

Alaska Oncology and Hematology LLC

Alaska Women's Cancer Care

Anchorage Oncology Centre

Katmai Oncology Group

Providence Alaska Medical Center

Fairbanks Memorial Hospital

CTCA at Western Regional Medical Center

Phoenix Childrens Hospital

University of Arizona Cancer Center-Orange Grove Campus

Banner University Medical Center - Tucson

University of Arizona Cancer Center-North Campus

Mercy Hospital Fort Smith

CHI Saint Vincent Cancer Center Hot Springs

Arkansas Children's Hospital

University of Arkansas for Medical Sciences

Kaiser Permanente-Anaheim

PCR Oncology

Kaiser Permanente-Baldwin Park

Kaiser Permanente-Bellflower

Providence Saint Joseph Medical Center/Disney Family Cancer Center

City of Hope Comprehensive Cancer Center

Kaiser Permanente-Fontana

Kaiser Permanente - Harbor City

Kaiser Permanente-Irvine

UC San Diego Moores Cancer Center

Kaiser Permanente Los Angeles Medical Center

Kaiser Permanente-Cadillac

Fremont - Rideout Cancer Center

Kaiser Permanente-Oakland

Children's Hospital of Orange County

UC Irvine Health/Chao Family Comprehensive Cancer Center

Desert Regional Medical Center

Stanford Cancer Institute Palo Alto

Kaiser Permanente - Panorama City

Kaiser Permanente-Riverside

Sutter Medical Center Sacramento

University of California Davis Comprehensive Cancer Center

Kaiser Permanente-San Diego Zion

Naval Medical Center -San Diego

Kaiser Permanente-San Marcos

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Presbyterian Intercommunity Hospital

Kaiser Permanente-Woodland Hills

Rocky Mountain Cancer Centers-Aurora

The Medical Center of Aurora

Children's Hospital Colorado

University of Colorado Hospital

Boulder Community Hospital

Rocky Mountain Cancer Centers-Boulder

Penrose-Saint Francis Healthcare

Rocky Mountain Cancer Centers-Penrose

Porter Adventist Hospital

Presbyterian - Saint Lukes Medical Center - Health One

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

SCL Health Saint Joseph Hospital

Swedish Medical Center

Saint Mary's Hospital and Regional Medical Center

North Colorado Medical Center

Saint Anthony Hospital

Rocky Mountain Cancer Centers-Littleton

Littleton Adventist Hospital

Sky Ridge Medical Center

Longmont United Hospital

McKee Medical Center

Parker Adventist Hospital

Saint Mary Corwin Medical Center

SCL Health Lutheran Medical Center

Smilow Cancer Center/Yale-New Haven Hospital

Yale University

Beebe Medical Center

Delaware Clinical and Laboratory Physicians PA

Helen F Graham Cancer Center

Medical Oncology Hematology Consultants PA

Christiana Care Health System-Christiana Hospital

Beebe Health Campus

Nanticoke Memorial Hospital

Alfred I duPont Hospital for Children

MedStar Georgetown University Hospital

UM Sylvester Comprehensive Cancer Center at Coral Gables

Golisano Children's Hospital of Southwest Florida

UM Sylvester Comprehensive Cancer Center at Hollywood

Nemours Children's Clinic-Jacksonville

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami Cancer Institute

UF Cancer Center at Orlando Health

Nemours Children's Hospital

Moffitt Cancer Center-International Plaza

Saint Joseph's Hospital/Children's Hospital-Tampa

Moffitt Cancer Center - McKinley Campus

Moffitt Cancer Center

Saint Mary's Hospital

Children's Healthcare of Atlanta - Egleston

Emory University Hospital/Winship Cancer Institute

Emory Saint Joseph's Hospital

Memorial Health University Medical Center

Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma

A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age &gt;/= 12 Years) With Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma

Will test the null hypothesis (HR=1) for PFS using stratified log-rank test with a one-sided alpha of 0.021. The analysis will be based on modified intent-to-treat and will include all eligible patients as randomized regardless of treatment received. The one-sided alpha of .021 will control of the overall type-one error of the study (including the 2 interim superiority analyses) to be less than .025.

Will be estimated using Kaplan-Meier method and compared between treatment arms using cox regression model.

Defined using 2014 Lugano classification.

Toxicity will be evaluated using Common Terminology Criteria of Adverse Events (CTCAE) version 5 items. Treatment-related toxicities between arms will be compared using Fisher's exact test stratified by age groups. Targeted patient-reported toxicities also will be collected at each time point using the Patient Reported Outcome (PRO)-CTCAE for patients 18 years and older and from youth 12-17 years, using the Pediatric (Ped) PRO-CTCAE.

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page

National Cancer Institute (NCI)

Brentuximab Vedotin dose will start at 1.2 mg/kg by intravenous (IV) infusion on Day1 and Day15 plus Cyclophosphamide 500mg/m2 IV on Day1 plus Procarbazine 100mg/m2 by mouth (OR) on Day1 through 5 plus Etoposide 60mg/m2 OR on Day15 through 19 plus Mitoxantrone 6mg/m2 IV on Day15 and Prednisone 30mg/m2 on Day1 through 5 of each 28-day treatment cycles for up to 6 total treatment cycles (approximately 24 weeks or 6 months)

Hodgkin Lymphoma

All patients will be treated with 6 cycles of BV-EPEM

BrentuximabVedotin (BV)

Institut Català d'Oncologia, Hospital Germans Trias i Pujol

Institut Català d'Oncologia, Hospital Duran i Reynals

Hospital Costa del Sol

Hospital Clinic i Provincial de Barcelona

Hospital Vall d'Hebron

Hospital de Basurto

Hospital General Universitario Gregorio Marañon

Hospital Universitario 12 de Octubre

Hospital Universitario La Paz

Hospital Son Llatzer

Hospital Universitario de Salamanca

Hospital Universitario Donostia - Arantzazu

Hospital Universitario Marqués de Valdecilla

Hospital Universitario Virgen del Rocío

Hospital Universitario Miguel Servet

BrEPEM-LH-22017 for Older Patients With Untreated Hodgkin Lymphoma (HL)

A Phase Ib/II Trial of Combined SGN-35 (BrentuximabVedotin) Therapy With Cyclophosphamide, Procarbazine, Prednisone, Etoposide and Mitoxantrone (BrEPEM) for Older Patients With Untreated Hodgkin Lymphoma (HL)

To identify the maximum tolerated dose (MTD) of Brentuximab Vedotin (BV) in combination with EPEM

To assess the percentage of patients with complete response rate after BV-EPEM treatment.

To evaluate the toxicity of the treatment by measure of number of treatment-related adverse events according to CTCAE v4.0

Evaluation of patient without progression of disease

length of time between date of evidence response and progression of disease or death

To evaluate overall response rate (ORR) based on best response (CR and PR) and the tumor local control rate (CR, PR, and stable disease [SD]) with this treatment regimen.

To assess the type, frequency, severity and relationship of adverse events (AEs) to this treatment regimen.

evaluation of patients alive after first dose of treatment and follow up

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Takeda

Standard sequence of radiotherapy = whole pelvic lymphatics, proximal seminal vesicles, prostate (or prostate bed) first, then prostate/prostate bed last

Experimental sequence of radiotherapy = whole pelvic lymphatics, proximal seminal vesicles, prostate (or prostate bed) last, prostate/prostate bed first

Prostatic Neoplasms

Docetaxel

Leuprolide Acetate (Eligard®)

Standard sequence = irradiation of pelvic lymphatics, seminal vesicles, and prostate, followed by irradiation of gross tumor (prostate+extraprostatic extension, as determined by MRI)

Intensity-Modulated Radiotherapy

Experimental sequence = irradiation of pelvic lymphatics, seminal vesicles, and prostate last, irradiation of gross tumor (prostate+extraprostatic extension, as determined by MRI)first

Nova Scotia Cancer Centre

The ELDORADO (Eligard®, Docetaxel and Radiotherapy) Study

The ELDORADO (Eligard®, Docetaxel and Radiotherapy) Study: A Phase II Study of Chemo - Hormonal Therapy and Radiation in High Risk Prostate Cancer

Derek R Wilke MD,MSc,FRCPC

Research Director, Department of Radiation Oncology

Lymphoma

Psychosocial Effects of Cancer and Its Treatment

Evaluate psychosocial function at prestudy, 6 months after starting treatment on S9133, and annually at 1-7 years after starting treatment on S9133.

psychosocial assessment and care

Evaluate quality of life at prestudy, 6 months after starting treatment on S9133, and annually at 1-7 years after starting treatment on S9133.

quality-of-life assessment

Walter Reed Army Medical Center

University of Iowa Hospitals and Clinics

University of Massachusetts Memorial Medical Center

Ellis Fischel Cancer Center - Columbia

Barnes-Jewish Hospital

Roswell Park Cancer Institute

Beth Israel Medical Center

State University of New York - Upstate Medical University

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Rhode Island Hospital

University of Tennessee, Memphis Cancer Center

SWOG-9208 Quality of Life and Health Status in Patients With Stage I or Stage II Hodgkin's Disease

Health Status and Quality of Life in Patients With Early Stage Hodgkin's Disease: A Companion Study to SWOG-9133

Southwest Oncology Group

Cancer and Leukemia Group B

vinblastine/fatigue

Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma

BrEPEM-LH-22017 for Older Patients With Untreated Hodgkin Lymphoma (HL)

The ELDORADO (Eligard®, Docetaxel and Radiotherapy) Study

SWOG-9208 Quality of Life and Health Status in Patients With Stage I or Stage II Hodgkin's Disease

An bunachar luibheanna míochaine is iomláine le tacaíocht ón eolaíocht