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Брентуксимаб ведотин и ниволумаб с ипилимумабом или без него в лечении пациентов с рецидивирующей или рефрактерной лимфомой Ходжкина

21 октября 2026 г. обновлено: National Cancer Institute (NCI)

Исследование фазы I с расширенной когортой/рандомизированное исследование фазы II комбинаций ипилимумаба, ниволумаба и брентуксимаба ведотина у пациентов с рецидивирующей/резистентной лимфомой Ходжкина

This phase I/II trial studies the side effects and best dose of ipilimumab and nivolumab when given together with brentuximab vedotin, and how well they work in treating patients with Hodgkin lymphoma that has returned after a period of improvement (recurrent) or has not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. It is not known whether giving brentuximab vedotin and nivolumab with or without ipilimumab may kill more cancer cells.

Обзор исследования

Статус

Активный, не рекрутирующий

Условия

Вмешательство/лечение

Подробное описание

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of the combinations of brentuximab vedotin and ipilimumab, brentuximab vedotin and nivolumab, and brentuximab vedotin, ipilimumab, and nivolumab. (Phase I) II. To evaluate the complete response (CR) rate for the regimens of brentuximab vedotin and nivolumab compared to brentuximab vedotin, ipilimumab, and nivolumab. (Phase II; adult cohort [aged >= 18 years]) III. To characterize the safety and toxicity of treatment combination in the pediatric population. (Phase II; pediatric cohort [aged 12-17 years])

SECONDARY OBJECTIVES:

I. To evaluate complete response (CR) rate, partial response (PR) rate and overall response rate (ORR), for the combinations of brentuximab vedotin and ipilimumab, brentuximab vedotin and nivolumab, and brentuximab vedotin, ipilimumab, and nivolumab. (Phase I) II. To evaluate the duration of remission (DOR) to these combinations and compare with the DOR achieved with the most recent prior systemic therapy. (Phase I) III. To evaluate the progression-free survival (PFS) and the overall survival (OS) in patients receiving the combination of brentuximab vedotin and ipilimumab, brentuximab vedotin and nivolumab, and brentuximab vedotin, ipilimumab, and nivolumab. (Phase I) IV. To evaluate the ORR, PR, and stable disease (SD) rate for the combinations of brentuximab vedotin and nivolumab and brentuximab vedotin, ipilimumab, and nivolumab. (Phase II) V. To evaluate the DOR to these combinations and compare with the DOR achieved with the most recent prior systemic therapy. (Phase II) VI. To evaluate the 5 year PFS and OS in patients receiving the combinations of brentuximab vedotin and nivolumab and brentuximab vedotin, ipilimumab, and nivolumab. (Phase II) VII. To further evaluate the safety and characterize the toxicity for the combinations of brentuximab vedotin and nivolumab, and brentuximab vedotin, ipilimumab, and nivolumab. (Phase II)

CORRELATIVE STUDY OBJECTIVES:

I. To evaluate the ability of these combinations to alter tumor specific T cell immunity. (Phase I) II. To evaluate the effects of these combinations on systemic immunity. (Phase I) III. To evaluate a panel of cytokine and T cell specific biomarkers from the peripheral blood as a potential immune signature of treatment response to therapy with these combinations for patients with relapsed/refractory Hodgkin lymphoma (HL). (Phase I) IV. To evaluate using gene expression profiling (GEP) a signature of response to these novel combinations of an antibody drug conjugate with immunomodulatory therapy. (Phase I) V. To evaluate the ability of these combinations to alter tumor specific T cell immunity, and circulating T cell phenotypes, in patients as a function of treatment response at multiple timepoints during therapy. (Phase II) VI. To evaluate peripheral blood cytokine profiles in responding and resistant patients at multiple timepoints during therapy. (Phase II) VII. To evaluate using GEP a signature of response versus (vs.) resistance to these novel combinations of an antibody drug conjugate with immunomodulatory therapy. (Phase II) VIII. To evaluate the influence of human gut microbiome dysbiosis on HL lymphomagenesis and the systemic immune response. (Phase II)

IMAGING CORRELATIVE STUDY OBJECTIVES:

I. To evaluate atypical response patterns with currently available response evaluation criteria. (Phase II) II. To correlate response evaluated using currently available response evaluation criteria with duration of response (PFS, event free survival [EFS], failure free survival [FFS]). (Phase II) III. To evaluate response patterns in different immunotherapy treatment schemes and correlate with historical data using chemotherapy. (Phase II) IV. To correlate imaging changes in all treatment schemes quantitatively with PFS. (Phase II)

EXPLORATORY OBJECTIVES:

I. Evaluate outcomes (CR, PFS) between patients with/without prior transplants. (Phase II) II. Evaluate outcomes (PFS, OS) between the patients who stay on treatment and do not go to transplant in both arms (the post auto and the few others who don't want transplant) vs the patients who go off for transplant. (Phase II) III. Evaluate outcomes (CR, PFS) in pediatric population (age 12 to < 18 years of age) vs. adult population. (Phase II)

OUTLINE: This is a phase I, dose-escalation study of brentuximab vedotin, ipilimumab, and nivolumab followed by a phase II study.

PHASE I: Patients are assigned into 1 of 3 arms.

ARM I: Patients receive brentuximab vedotin intravenously (IV) over 90 minutes on day 1 of cycles 1-16 and ipilimumab IV over 30 minutes on day 1 of cycles 1-4, 8, 12, and 16. Treatment repeats every 21 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive brentuximab vedotin IV over 90 minutes on day 1 of cycles 1-16 and nivolumab IV over 30 minutes on day 1 of cycles 1-46. Treatment repeats every 21 days for up to 16 cycles and every 14 days beginning cycle 17 for up to 46 cycles in the absence of disease progression or unacceptable toxicity.

ARM III: Patients receive brentuximab vedotin IV over 90 minutes on day 1 of cycles 1-16, nivolumab IV over 30 minutes on day 1 of cycles 1-46, and ipilimumab IV over 30 minutes on day 1 every 12 weeks for up to 9 doses. Treatment repeats every 21 days for up to 16 cycles and every 14 days beginning cycle 17 for up to 46 cycles in the absence of disease progression or unacceptable toxicity.

PHASE II: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive brentuximab vedotin IV over 30 minutes on day 1 of cycles 1-16 and nivolumab IV over 90 minutes on day 1 of cycles 1-34. Treatment repeats every 21 days for up to 34 cycles in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive brentuximab vedotin IV over 90 minutes on day 1 of cycles 1-16, nivolumab IV over 30 minutes on day 1 of cycles 1-34, and ipilimumab IV over 30 minutes on day 1 every 12 weeks for up to 9 doses. Treatment repeats every 21 days for up to 34 cycles in the absence of disease progression or unacceptable toxicity.

All patients also undergo computed tomography (CT) or positron emission tomography (PET) scan throughout the trial. Patients undergo blood sample collection and may undergo tumor biopsy on study.

After completion of phase I study treatment, patients are followed up every 3 months for 1 year, then every 6 months for 2 years. After completion of phase II study treatment, patients are followed up for 10 years.

Тип исследования

Интервенционный

Регистрация (Оцененный)

146

Фаза

Фаза 2
Фаза 1

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Соединенные Штаты
- Alabama
  - Birmingham, Alabama, Соединенные Штаты, 35233
    - University of Alabama at Birmingham Cancer Center
  - Birmingham, Alabama, Соединенные Штаты, 35233
    - Children's Hospital of Alabama
- Alaska
  - Anchorage, Alaska, Соединенные Штаты, 98508
    - Anchorage Associates in Radiation Medicine
  - Anchorage, Alaska, Соединенные Штаты, 99508
    - Alaska Breast Care and Surgery LLC
  - Anchorage, Alaska, Соединенные Штаты, 99508
    - Alaska Oncology and Hematology LLC
  - Anchorage, Alaska, Соединенные Штаты, 99508
    - Alaska Women's Cancer Care
  - Anchorage, Alaska, Соединенные Штаты, 99508
    - Anchorage Oncology Centre
  - Anchorage, Alaska, Соединенные Штаты, 99508
    - Katmai Oncology Group
  - Anchorage, Alaska, Соединенные Штаты, 99508
    - Providence Alaska Medical Center
  - Anchorage, Alaska, Соединенные Штаты, 99504
    - Anchorage Radiation Therapy Center
  - Fairbanks, Alaska, Соединенные Штаты, 99701
    - Fairbanks Memorial Hospital
- Arizona
  - Kingman, Arizona, Соединенные Штаты, 86401
    - Kingman Regional Medical Center
  - Phoenix, Arizona, Соединенные Штаты, 85004
    - Cancer Center at Saint Joseph's
- Arkansas
  - Fort Smith, Arkansas, Соединенные Штаты, 72903
    - Mercy Hospital Fort Smith
  - Hot Springs, Arkansas, Соединенные Штаты, 71913
    - CHI Saint Vincent Cancer Center Hot Springs
- California
  - Antioch, California, Соединенные Штаты, 94531
    - Kaiser Permanente-Deer Valley Medical Center
  - Arroyo Grande, California, Соединенные Штаты, 93420
    - PCR Oncology
  - Arroyo Grande, California, Соединенные Штаты, 93420
    - Mission Hope Medical Oncology - Arroyo Grande
  - Burbank, California, Соединенные Штаты, 91505
    - Providence Saint Joseph Medical Center/Disney Family Cancer Center
  - Dublin, California, Соединенные Штаты, 94568
    - Kaiser Permanente Dublin
  - Fremont, California, Соединенные Штаты, 94538
    - Kaiser Permanente-Fremont
  - Fresno, California, Соединенные Штаты, 93720
    - Kaiser Permanente-Fresno
  - Fresno, California, Соединенные Штаты, 93720
    - Fresno Cancer Center
  - Modesto, California, Соединенные Штаты, 95356
    - Kaiser Permanente-Modesto
  - Oakland, California, Соединенные Штаты, 94611
    - Kaiser Permanente-Oakland
  - Oakland, California, Соединенные Штаты, 94611
    - Kaiser Permanente Oakland-Broadway
  - Orange, California, Соединенные Штаты, 92868
    - Children's Hospital of Orange County
  - Palo Alto, California, Соединенные Штаты, 94304
    - Stanford Cancer Institute Palo Alto
  - Rancho Cordova, California, Соединенные Штаты, 95670
    - Kaiser Permanente-Rancho Cordova Cancer Center
  - Redwood City, California, Соединенные Штаты, 94063
    - Kaiser Permanente-Redwood City
  - Richmond, California, Соединенные Штаты, 94801
    - Kaiser Permanente-Richmond
  - Rohnert Park, California, Соединенные Штаты, 94928
    - Rohnert Park Cancer Center
  - Roseville, California, Соединенные Штаты, 95678
    - The Permanente Medical Group-Roseville Radiation Oncology
  - Roseville, California, Соединенные Штаты, 95661
    - Kaiser Permanente-Roseville
  - Sacramento, California, Соединенные Штаты, 95814
    - Kaiser Permanente Downtown Commons
  - Sacramento, California, Соединенные Штаты, 95823
    - Kaiser Permanente-South Sacramento
  - Sacramento, California, Соединенные Штаты, 95823
    - South Sacramento Cancer Center
  - Sacramento, California, Соединенные Штаты, 95825
    - Kaiser Permanente Sacramento Medical Center
  - San Francisco, California, Соединенные Штаты, 94115
    - Kaiser Permanente-San Francisco
  - San Francisco, California, Соединенные Штаты, 94158
    - UCSF Medical Center-Mission Bay
  - San Jose, California, Соединенные Штаты, 95119
    - Kaiser Permanente-Santa Teresa-San Jose
  - San Leandro, California, Соединенные Штаты, 94577
    - Kaiser Permanente San Leandro
  - San Luis Obispo, California, Соединенные Штаты, 93401
    - Pacific Central Coast Health Center-San Luis Obispo
  - San Rafael, California, Соединенные Штаты, 94903
    - Kaiser San Rafael-Gallinas
  - San Rafael, California, Соединенные Штаты, 94903
    - Kaiser Permanente-San Rafael
  - Santa Clara, California, Соединенные Штаты, 95051
    - Kaiser Permanente Medical Center - Santa Clara
  - Santa Maria, California, Соединенные Штаты, 93444
    - Mission Hope Medical Oncology - Santa Maria
  - Santa Rosa, California, Соединенные Штаты, 95403
    - Kaiser Permanente-Santa Rosa
  - South San Francisco, California, Соединенные Штаты, 94080
    - Kaiser Permanente Cancer Treatment Center
  - South San Francisco, California, Соединенные Штаты, 94080
    - Kaiser Permanente-South San Francisco
  - Stockton, California, Соединенные Штаты, 95210
    - Kaiser Permanente-Stockton
  - Vacaville, California, Соединенные Штаты, 95688
    - Kaiser Permanente Medical Center-Vacaville
  - Vallejo, California, Соединенные Штаты, 94589
    - Kaiser Permanente-Vallejo
  - Walnut Creek, California, Соединенные Штаты, 94596
    - Kaiser Permanente-Walnut Creek
- Colorado
  - Aurora, Colorado, Соединенные Штаты, 80012
    - Rocky Mountain Cancer Centers-Aurora
  - Aurora, Colorado, Соединенные Штаты, 80012
    - The Medical Center of Aurora
  - Boulder, Colorado, Соединенные Штаты, 80303
    - Boulder Community Foothills Hospital
  - Boulder, Colorado, Соединенные Штаты, 80304
    - Rocky Mountain Cancer Centers-Boulder
  - Centennial, Colorado, Соединенные Штаты, 80112
    - Rocky Mountain Cancer Centers - Centennial
  - Colorado Springs, Colorado, Соединенные Штаты, 80907
    - Penrose-Saint Francis Healthcare
  - Colorado Springs, Colorado, Соединенные Штаты, 80907
    - Rocky Mountain Cancer Centers-Penrose
  - Denver, Colorado, Соединенные Штаты, 80218
    - Presbyterian - Saint Lukes Medical Center - Health One
  - Denver, Colorado, Соединенные Штаты, 80218
    - Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
  - Denver, Colorado, Соединенные Штаты, 80220
    - Rose Medical Center
  - Denver, Colorado, Соединенные Штаты, 80218
    - Rocky Mountain Cancer Centers-Midtown
  - Denver, Colorado, Соединенные Штаты, 80220
    - Rocky Mountain Cancer Centers-Rose
  - Denver, Colorado, Соединенные Штаты, 80204
    - Denver Health Medical Center
  - Denver, Colorado, Соединенные Штаты, 80218
    - Colorado Blood Cancer Institute
  - Denver, Colorado, Соединенные Штаты, 80204
    - Cancer Center of Colorado at Sloan's Lake
  - Denver, Colorado, Соединенные Штаты, 80209
    - The Women's Imaging Center
  - Denver, Colorado, Соединенные Штаты, 80206
    - National Jewish Health-Main Campus
  - Denver, Colorado, Соединенные Штаты, 80220
    - Western Surgical Care
  - Denver, Colorado, Соединенные Штаты, 80218
    - Saint Joseph Hospital - Cancer Centers of Colorado
  - Denver, Colorado, Соединенные Штаты, 80210
    - AdventHealth Porter
  - Durango, Colorado, Соединенные Штаты, 81301
    - Mercy Medical Center
  - Durango, Colorado, Соединенные Штаты, 81301
    - CommonSpirit Cancer Center Mercy
  - Englewood, Colorado, Соединенные Штаты, 80113
    - Mountain Blue Cancer Care Center - Swedish
  - Englewood, Colorado, Соединенные Штаты, 80113
    - Swedish Medical Center
  - Englewood, Colorado, Соединенные Штаты, 80113
    - Rocky Mountain Cancer Centers - Swedish
  - Golden, Colorado, Соединенные Штаты, 80401
    - Mountain Blue Cancer Care Center
  - Golden, Colorado, Соединенные Штаты, 80401
    - National Jewish Health-Western Hematology Oncology
  - Grand Junction, Colorado, Соединенные Штаты, 81501
    - Saint Mary's Hospital and Regional Medical Center
  - Greeley, Colorado, Соединенные Штаты, 80631
    - Banner North Colorado Medical Center
  - Lafayette, Colorado, Соединенные Штаты, 80026
    - Good Samaritan Hospital - Cancer Centers of Colorado
  - Lakewood, Colorado, Соединенные Штаты, 80228
    - Rocky Mountain Cancer Centers-Lakewood
  - Lakewood, Colorado, Соединенные Штаты, 80228
    - CommonSpirit Saint Anthony Hospital Cancer Center
  - Littleton, Colorado, Соединенные Штаты, 80120
    - Rocky Mountain Cancer Centers-Littleton
  - Littleton, Colorado, Соединенные Штаты, 80122
    - AdventHealth Littleton
  - Lone Tree, Colorado, Соединенные Штаты, 80124
    - Sky Ridge Medical Center
  - Lone Tree, Colorado, Соединенные Штаты, 80124
    - Rocky Mountain Cancer Centers-Sky Ridge
  - Longmont, Colorado, Соединенные Штаты, 80501
    - Longmont United Hospital
  - Longmont, Colorado, Соединенные Штаты, 80501
    - Rocky Mountain Cancer Centers-Longmont
  - Loveland, Colorado, Соединенные Штаты, 80539
    - Banner North Colorado Medical Center - Loveland Campus
  - Parker, Colorado, Соединенные Штаты, 80138
    - Rocky Mountain Cancer Centers-Parker
  - Parker, Colorado, Соединенные Штаты, 80138
    - AdventHealth Parker
  - Pueblo, Colorado, Соединенные Штаты, 81008
    - Rocky Mountain Cancer Centers - Pueblo
  - Thornton, Colorado, Соединенные Штаты, 80260
    - Rocky Mountain Cancer Centers-Thornton
  - Thornton, Colorado, Соединенные Штаты, 80260
    - National Jewish Health-Northern Hematology Oncology
  - Wheat Ridge, Colorado, Соединенные Штаты, 80401
    - Intermountain Health Lutheran Hospital
- District of Columbia
  - Washington D.C., District of Columbia, Соединенные Штаты, 20010
    - Children's National Medical Center
- Florida
  - Fort Myers, Florida, Соединенные Штаты, 33905
    - Regional Cancer Center-Lee Memorial Health System
  - Fort Myers, Florida, Соединенные Штаты, 33908
    - Golisano Children's Hospital of Southwest Florida
  - St. Petersburg, Florida, Соединенные Штаты, 33701
    - Johns Hopkins All Children's Hospital
  - Tampa, Florida, Соединенные Штаты, 33606
    - Tampa General Hospital
  - Tampa, Florida, Соединенные Штаты, 33607
    - Saint Joseph's Hospital/Children's Hospital-Tampa
- Georgia
  - Atlanta, Georgia, Соединенные Штаты, 30322
    - Emory University Hospital/Winship Cancer Institute
  - Atlanta, Georgia, Соединенные Штаты, 30329
    - Children's Healthcare of Atlanta - Arthur M Blank Hospital
- Hawaii
  - Honolulu, Hawaii, Соединенные Штаты, 96819
    - Kaiser Permanente Moanalua Medical Center
- Idaho
  - Boise, Idaho, Соединенные Штаты, 83706
    - Saint Alphonsus Cancer Care Center-Boise
  - Boise, Idaho, Соединенные Штаты, 83712
    - Saint Luke's Cancer Institute - Boise
  - Caldwell, Idaho, Соединенные Штаты, 83605
    - Saint Alphonsus Cancer Care Center-Caldwell
  - Coeur d'Alene, Idaho, Соединенные Штаты, 83814
    - Kootenai Health - Coeur d'Alene
  - Emmett, Idaho, Соединенные Штаты, 83617
    - Walter Knox Memorial Hospital
  - Fruitland, Idaho, Соединенные Штаты, 83619
    - Saint Luke's Cancer Institute - Fruitland
  - Meridian, Idaho, Соединенные Штаты, 83642
    - Idaho Urologic Institute-Meridian
  - Meridian, Idaho, Соединенные Штаты, 83642
    - Saint Luke's Cancer Institute - Meridian
  - Nampa, Idaho, Соединенные Штаты, 83687
    - Saint Alphonsus Cancer Care Center-Nampa
  - Nampa, Idaho, Соединенные Штаты, 83687
    - Saint Luke's Cancer Institute - Nampa
  - Post Falls, Idaho, Соединенные Штаты, 83854
    - Kootenai Clinic Cancer Services - Post Falls
  - Sandpoint, Idaho, Соединенные Штаты, 83864
    - Kootenai Clinic Cancer Services - Sandpoint
  - Twin Falls, Idaho, Соединенные Штаты, 83301
    - Saint Luke's Cancer Institute - Twin Falls
- Illinois
  - Alton, Illinois, Соединенные Штаты, 62002
    - OSF Saint Anthony's Health Center
  - Aurora, Illinois, Соединенные Штаты, 60504
    - Rush-Copley Medical Center
  - Bloomington, Illinois, Соединенные Штаты, 61704
    - Illinois CancerCare-Bloomington
  - Canton, Illinois, Соединенные Штаты, 61520
    - Illinois CancerCare-Canton
  - Carbondale, Illinois, Соединенные Штаты, 62902
    - Memorial Hospital of Carbondale
  - Carterville, Illinois, Соединенные Штаты, 62918
    - SIH Cancer Institute
  - Carthage, Illinois, Соединенные Штаты, 62321
    - Illinois CancerCare-Carthage
  - Centralia, Illinois, Соединенные Штаты, 62801
    - Centralia Oncology Clinic
  - Chicago, Illinois, Соединенные Штаты, 60611
    - Northwestern University
  - Chicago, Illinois, Соединенные Штаты, 60612
    - University of Illinois
  - Chicago, Illinois, Соединенные Штаты, 60612
    - Rush MD Anderson Cancer Center
  - Danville, Illinois, Соединенные Штаты, 61832
    - Carle at The Riverfront
  - Decatur, Illinois, Соединенные Штаты, 62526
    - Decatur Memorial Hospital
  - Decatur, Illinois, Соединенные Штаты, 62526
    - Cancer Care Specialists of Illinois - Decatur
  - Dixon, Illinois, Соединенные Штаты, 61021
    - Illinois CancerCare-Dixon
  - Effingham, Illinois, Соединенные Штаты, 62401
    - Crossroads Cancer Center
  - Effingham, Illinois, Соединенные Штаты, 62401
    - Carle Physician Group-Effingham
  - Eureka, Illinois, Соединенные Штаты, 61530
    - Illinois CancerCare-Eureka
  - Galesburg, Illinois, Соединенные Штаты, 61401
    - Western Illinois Cancer Treatment Center
  - Galesburg, Illinois, Соединенные Штаты, 61401
    - Illinois CancerCare-Galesburg
  - Joliet, Illinois, Соединенные Штаты, 60435
    - Duly Health and Care Joliet
  - Kewanee, Illinois, Соединенные Штаты, 61443
    - Illinois CancerCare-Kewanee Clinic
  - Macomb, Illinois, Соединенные Штаты, 61455
    - Illinois CancerCare-Macomb
  - Mattoon, Illinois, Соединенные Штаты, 61938
    - Carle Physician Group-Mattoon/Charleston
  - Mount Vernon, Illinois, Соединенные Штаты, 62864
    - SSM Health Good Samaritan
  - O'Fallon, Illinois, Соединенные Штаты, 62269
    - Cancer Care Center of O'Fallon
  - Ottawa, Illinois, Соединенные Штаты, 61350
    - Illinois CancerCare-Ottawa Clinic
  - Pekin, Illinois, Соединенные Штаты, 61554
    - Illinois CancerCare-Pekin
  - Peoria, Illinois, Соединенные Штаты, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, Соединенные Штаты, 61615
    - Illinois CancerCare-Peoria
  - Peru, Illinois, Соединенные Штаты, 61354
    - Illinois CancerCare-Peru
  - Peru, Illinois, Соединенные Штаты, 61354
    - Valley Radiation Oncology
  - Princeton, Illinois, Соединенные Штаты, 61356
    - Illinois CancerCare-Princeton
  - Springfield, Illinois, Соединенные Штаты, 62702
    - Southern Illinois University School of Medicine
  - Springfield, Illinois, Соединенные Штаты, 62702
    - Springfield Clinic
  - Springfield, Illinois, Соединенные Штаты, 62781
    - Springfield Memorial Hospital
  - Swansea, Illinois, Соединенные Штаты, 62226
    - Southwest Illinois Health Services LLP
  - Urbana, Illinois, Соединенные Штаты, 61801
    - Carle Cancer Center
  - Urbana, Illinois, Соединенные Штаты, 61801
    - The Carle Foundation Hospital
  - Washington, Illinois, Соединенные Штаты, 61571
    - Illinois CancerCare - Washington
  - Yorkville, Illinois, Соединенные Штаты, 60560
    - Rush-Copley Healthcare Center
- Indiana
  - Evansville, Indiana, Соединенные Штаты, 47713
    - Deaconess Clinic Downtown
  - Indianapolis, Indiana, Соединенные Штаты, 46202
    - Indiana University/Melvin and Bren Simon Cancer Center
  - Newburgh, Indiana, Соединенные Штаты, 47630
    - Chancellor Center for Oncology
- Iowa
  - Clive, Iowa, Соединенные Штаты, 50325
    - Mercy Cancer Center-West Lakes
  - Clive, Iowa, Соединенные Штаты, 50325
    - UI Health Care Mission Cancer and Blood - West Des Moines Clinic
  - Council Bluffs, Iowa, Соединенные Штаты, 51503
    - Alegent Health Mercy Hospital
  - Creston, Iowa, Соединенные Штаты, 50801
    - Greater Regional Medical Center
  - Des Moines, Iowa, Соединенные Штаты, 50314
    - Mercy Medical Center - Des Moines
  - Des Moines, Iowa, Соединенные Штаты, 50314
    - UI Health Care Mission Cancer and Blood - Laurel Clinic
  - West Des Moines, Iowa, Соединенные Штаты, 50266
    - Mercy Medical Center-West Lakes
- Kansas
  - Garden City, Kansas, Соединенные Штаты, 67846
    - Central Care Cancer Center - Garden City
  - Great Bend, Kansas, Соединенные Штаты, 67530
    - Central Care Cancer Center - Great Bend
- Kentucky
  - Bardstown, Kentucky, Соединенные Штаты, 40004
    - CommonSpirit Saint Joseph Hospital - Bardstown
  - Corbin, Kentucky, Соединенные Штаты, 40701
    - Commonwealth Cancer Center-Corbin
  - Lexington, Kentucky, Соединенные Штаты, 40504
    - Saint Joseph Radiation Oncology Resource Center
  - Lexington, Kentucky, Соединенные Штаты, 40509
    - CommonSpirit Saint Joseph Medical Center - East Lexington
  - London, Kentucky, Соединенные Штаты, 40741
    - CommonSpirit Saint Joseph Hospital London
  - Louisville, Kentucky, Соединенные Штаты, 40202
    - Jewish Hospital
  - Louisville, Kentucky, Соединенные Штаты, 40245
    - UofL Health Medical Center Northeast
  - Louisville, Kentucky, Соединенные Штаты, 40215
    - Saints Mary and Elizabeth Hospital
  - Paducah, Kentucky, Соединенные Штаты, 42003
    - Mercy Health - Paducah Cancer Center
  - Shepherdsville, Kentucky, Соединенные Штаты, 40165
    - Jewish Hospital Medical Center South
- Louisiana
  - Baton Rouge, Louisiana, Соединенные Штаты, 70805
    - LSU Health Baton Rouge-North Clinic
  - Baton Rouge, Louisiana, Соединенные Штаты, 70809
    - Louisiana Hematology Oncology Associates LLC
  - Baton Rouge, Louisiana, Соединенные Штаты, 70809
    - Mary Bird Perkins Cancer Center
  - Baton Rouge, Louisiana, Соединенные Штаты, 70808
    - Our Lady of The Lake
  - Baton Rouge, Louisiana, Соединенные Штаты, 70808
    - Our Lady of the Lake Physician Group
  - Covington, Louisiana, Соединенные Штаты, 70433
    - Northshore Oncology Associates-Covington
  - Houma, Louisiana, Соединенные Штаты, 70360
    - Terrebonne General Medical Center
  - Houma, Louisiana, Соединенные Штаты, 70360
    - Oncology Center of The South Incorporated
- Maryland
  - Baltimore, Maryland, Соединенные Штаты, 21287
    - Johns Hopkins University/Sidney Kimmel Cancer Center
  - Baltimore, Maryland, Соединенные Штаты, 21229
    - Saint Agnes Hospital
  - Bethesda, Maryland, Соединенные Штаты, 20889-5600
    - Walter Reed National Military Medical Center
- Massachusetts
  - Boston, Massachusetts, Соединенные Штаты, 02111
    - Tufts Medical Center
- Michigan
  - Port Huron, Michigan, Соединенные Штаты, 48060
    - Lake Huron Medical Center
  - Port Huron, Michigan, Соединенные Штаты, 48060
    - Huron Medical Center PC
- Minnesota
  - Aitkin, Minnesota, Соединенные Штаты, 56431
    - Riverwood Healthcare Center
  - Brainerd, Minnesota, Соединенные Штаты, 56401
    - Essentia Health Saint Joseph's Medical Center
  - Deer River, Minnesota, Соединенные Штаты, 56636
    - Essentia Health - Deer River Clinic
  - Detroit Lakes, Minnesota, Соединенные Штаты, 56501
    - Essentia Health Saint Mary's - Detroit Lakes Clinic
  - Duluth, Minnesota, Соединенные Штаты, 55805
    - Essentia Health Cancer Center
  - Duluth, Minnesota, Соединенные Штаты, 55805
    - Essentia Health Saint Mary's Medical Center
  - Duluth, Minnesota, Соединенные Штаты, 55805
    - Miller-Dwan Hospital
  - Fergus Falls, Minnesota, Соединенные Штаты, 56537
    - Lake Region Healthcare Corporation-Cancer Care
  - Fosston, Minnesota, Соединенные Штаты, 56542
    - Essentia Health - Fosston
  - Hibbing, Minnesota, Соединенные Штаты, 55746
    - Essentia Health Hibbing Clinic
  - Park Rapids, Minnesota, Соединенные Штаты, 56470
    - Essentia Health - Park Rapids
  - Rochester, Minnesota, Соединенные Штаты, 55905
    - Mayo Clinic in Rochester
  - Sandstone, Minnesota, Соединенные Штаты, 55072
    - Essentia Health Sandstone
  - Virginia, Minnesota, Соединенные Штаты, 55792
    - Essentia Health Virginia Clinic
- Missouri
  - Ballwin, Missouri, Соединенные Штаты, 63011
    - Mercy Oncology and Hematology - Clayton-Clarkson
  - Bolivar, Missouri, Соединенные Штаты, 65613
    - Central Care Cancer Center - Bolivar
  - Bonne Terre, Missouri, Соединенные Штаты, 63628
    - Parkland Health Center-Bonne Terre
  - Branson, Missouri, Соединенные Штаты, 65616
    - Cox Cancer Center Branson
  - Cape Girardeau, Missouri, Соединенные Штаты, 63703
    - Saint Francis Medical Center
  - Cape Girardeau, Missouri, Соединенные Штаты, 63703
    - Mercy Cancer Center - Cape Girardeau
  - Chesterfield, Missouri, Соединенные Штаты, 63017
    - Saint Luke's Hospital
  - City of Saint Peters, Missouri, Соединенные Штаты, 63376
    - Siteman Cancer Center at Saint Peters Hospital
  - Creve Coeur, Missouri, Соединенные Штаты, 63141
    - Siteman Cancer Center at West County Hospital
  - Farmington, Missouri, Соединенные Штаты, 63640
    - Parkland Health Center - Farmington
  - Jefferson City, Missouri, Соединенные Штаты, 65109
    - MU Health Care Goldschmidt Cancer Center
  - Joplin, Missouri, Соединенные Штаты, 64804
    - Freeman Health System
  - Joplin, Missouri, Соединенные Штаты, 64804
    - Mercy Hospital Joplin
  - Kansas City, Missouri, Соединенные Штаты, 64108
    - Children's Mercy Hospitals and Clinics
  - Rolla, Missouri, Соединенные Штаты, 65401
    - Mercy Clinic-Rolla-Cancer and Hematology
  - Rolla, Missouri, Соединенные Штаты, 65401
    - Phelps Health Delbert Day Cancer Institute
  - Saint Joseph, Missouri, Соединенные Штаты, 64506
    - Heartland Regional Medical Center
  - Sainte Genevieve, Missouri, Соединенные Штаты, 63670
    - Sainte Genevieve County Memorial Hospital
  - Springfield, Missouri, Соединенные Штаты, 65807
    - CoxHealth South Hospital
  - Springfield, Missouri, Соединенные Штаты, 65804
    - Mercy Hospital Springfield
  - St Louis, Missouri, Соединенные Штаты, 63110
    - Washington University School of Medicine
  - St Louis, Missouri, Соединенные Штаты, 63129
    - Siteman Cancer Center-South County
  - St Louis, Missouri, Соединенные Штаты, 63136
    - Siteman Cancer Center at Christian Hospital
  - St Louis, Missouri, Соединенные Штаты, 63131
    - Missouri Baptist Medical Center
  - St Louis, Missouri, Соединенные Штаты, 63109
    - Mercy Infusion Center - Chippewa
  - St Louis, Missouri, Соединенные Штаты, 63141
    - Mercy Hospital Saint Louis
  - St Louis, Missouri, Соединенные Штаты, 63128
    - Mercy Hospital South
  - Sullivan, Missouri, Соединенные Штаты, 63080
    - Missouri Baptist Sullivan Hospital
  - Washington, Missouri, Соединенные Штаты, 63090
    - Mercy Hospital Washington
- Montana
  - Anaconda, Montana, Соединенные Штаты, 59711
    - Community Hospital of Anaconda
  - Billings, Montana, Соединенные Штаты, 59101
    - Billings Clinic Cancer Center
  - Billings, Montana, Соединенные Штаты, 59101
    - Saint Vincent Healthcare
  - Billings, Montana, Соединенные Штаты, 59102
    - Saint Vincent Frontier Cancer Center
  - Bozeman, Montana, Соединенные Штаты, 59715
    - Bozeman Health Deaconess Hospital
  - Butte, Montana, Соединенные Штаты, 59701
    - Saint James Community Hospital and Cancer Treatment Center
  - Great Falls, Montana, Соединенные Штаты, 59405
    - Great Falls Clinic
  - Great Falls, Montana, Соединенные Штаты, 59405
    - Benefis Sletten Cancer Institute
  - Helena, Montana, Соединенные Штаты, 59601
    - Saint Peter's Community Hospital
  - Kalispell, Montana, Соединенные Штаты, 59901
    - Logan Health Medical Center
  - Missoula, Montana, Соединенные Штаты, 59802
    - Saint Patrick Hospital - Community Hospital
  - Missoula, Montana, Соединенные Штаты, 59804
    - Community Medical Center
- Nebraska
  - Grand Island, Nebraska, Соединенные Штаты, 68803
    - Nebraska Cancer Specialists/Oncology Hematology West PC
  - Kearney, Nebraska, Соединенные Штаты, 68847
    - CHI Health Good Samaritan
  - Kearney, Nebraska, Соединенные Штаты, 68845
    - Fred and Pamela Buffett Cancer Center - Kearney
  - Lincoln, Nebraska, Соединенные Штаты, 68510
    - Saint Elizabeth Regional Medical Center
  - Omaha, Nebraska, Соединенные Штаты, 68124
    - Alegent Health Bergan Mercy Medical Center
  - Omaha, Nebraska, Соединенные Штаты, 68122
    - Alegent Health Immanuel Medical Center
  - Omaha, Nebraska, Соединенные Штаты, 68130
    - Alegent Health Lakeside Hospital
  - Omaha, Nebraska, Соединенные Штаты, 68122
    - Hematology and Oncology Consultants PC
  - Papillion, Nebraska, Соединенные Штаты, 68046
    - Midlands Community Hospital
- Nevada
  - Carson City, Nevada, Соединенные Штаты, 89703
    - Carson Tahoe Regional Medical Center
  - Henderson, Nevada, Соединенные Штаты, 89052
    - Comprehensive Cancer Centers of Nevada - Henderson
  - Henderson, Nevada, Соединенные Штаты, 89052
    - Cancer and Blood Specialists-Henderson
  - Henderson, Nevada, Соединенные Штаты, 89052
    - Las Vegas Cancer Center-Henderson
  - Henderson, Nevada, Соединенные Штаты, 89074
    - Comprehensive Cancer Centers of Nevada-Southeast Henderson
  - Henderson, Nevada, Соединенные Штаты, 89052
    - Comprehensive Cancer Centers of Nevada-Horizon Ridge
  - Henderson, Nevada, Соединенные Штаты, 89074
    - Las Vegas Urology - Green Valley
  - Henderson, Nevada, Соединенные Штаты, 89074
    - Las Vegas Urology - Pebble
  - Henderson, Nevada, Соединенные Штаты, 89074
    - Urology Specialists of Nevada - Green Valley
  - Henderson, Nevada, Соединенные Штаты, 89074
    - Oncology Las Vegas - Henderson
  - Las Vegas, Nevada, Соединенные Штаты, 89144
    - Summerlin Hospital Medical Center
  - Las Vegas, Nevada, Соединенные Штаты, 89109
    - Sunrise Hospital and Medical Center
  - Las Vegas, Nevada, Соединенные Штаты, 89102
    - OptumCare Cancer Care at Charleston
  - Las Vegas, Nevada, Соединенные Штаты, 89106
    - Radiation Oncology Centers of Nevada Central
  - Las Vegas, Nevada, Соединенные Штаты, 89119
    - Radiation Oncology Centers of Nevada Southeast
  - Las Vegas, Nevada, Соединенные Штаты, 89128
    - Comprehensive Cancer Centers of Nevada - Northwest
  - Las Vegas, Nevada, Соединенные Штаты, 89128
    - OptumCare Cancer Care at MountainView
  - Las Vegas, Nevada, Соединенные Штаты, 89135
    - Alliance for Childhood Diseases/Cure 4 the Kids Foundation
  - Las Vegas, Nevada, Соединенные Штаты, 89144
    - Comprehensive Cancer Centers of Nevada - Town Center
  - Las Vegas, Nevada, Соединенные Штаты, 89144
    - Comprehensive Cancer Centers of Nevada-Summerlin
  - Las Vegas, Nevada, Соединенные Штаты, 89148
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, Соединенные Штаты, 89169
    - Comprehensive Cancer Centers of Nevada - Central Valley
  - Las Vegas, Nevada, Соединенные Штаты, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, Соединенные Штаты, 89106
    - Cancer and Blood Specialists-Shadow
  - Las Vegas, Nevada, Соединенные Штаты, 89109
    - HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
  - Las Vegas, Nevada, Соединенные Штаты, 89113
    - HealthCare Partners Medical Group Oncology/Hematology-San Martin
  - Las Vegas, Nevada, Соединенные Штаты, 89128
    - Cancer and Blood Specialists-Tenaya
  - Las Vegas, Nevada, Соединенные Штаты, 89128
    - HealthCare Partners Medical Group Oncology/Hematology-Tenaya
  - Las Vegas, Nevada, Соединенные Штаты, 89148-2405
    - Las Vegas Cancer Center-Medical Center
  - Las Vegas, Nevada, Соединенные Штаты, 89149
    - HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
  - Las Vegas, Nevada, Соединенные Штаты, 89128
    - Ann M Wierman MD LTD
  - Las Vegas, Nevada, Соединенные Штаты, 89074
    - Las Vegas Urology - Pecos
  - Las Vegas, Nevada, Соединенные Штаты, 89102
    - Desert West Surgery
  - Las Vegas, Nevada, Соединенные Штаты, 89103
    - Hope Cancer Care of Nevada
  - Las Vegas, Nevada, Соединенные Штаты, 89106
    - Urology Specialists of Nevada - Central
  - Las Vegas, Nevada, Соединенные Штаты, 89113
    - Las Vegas Prostate Cancer Center
  - Las Vegas, Nevada, Соединенные Штаты, 89113
    - Las Vegas Urology - Sunset
  - Las Vegas, Nevada, Соединенные Штаты, 89128
    - Las Vegas Urology - Cathedral Rock
  - Las Vegas, Nevada, Соединенные Штаты, 89128
    - Las Vegas Urology - Smoke Ranch
  - Las Vegas, Nevada, Соединенные Штаты, 89128
    - Urology Specialists of Nevada - Northwest
  - Las Vegas, Nevada, Соединенные Штаты, 89169
    - University Cancer Center
  - Las Vegas, Nevada, Соединенные Штаты, 89113
    - Urology Specialists of Nevada - Southwest
  - Las Vegas, Nevada, Соединенные Штаты, 89128
    - Oncology Las Vegas - Tenaya
  - Las Vegas, Nevada, Соединенные Штаты, 89183
    - OptumCare Cancer Care at Fort Apache
  - Pahrump, Nevada, Соединенные Штаты, 89048
    - Hope Cancer Care of Nevada-Pahrump
  - Reno, Nevada, Соединенные Штаты, 89502
    - Renown Regional Medical Center
  - Reno, Nevada, Соединенные Штаты, 89503
    - Saint Mary's Regional Medical Center
  - Reno, Nevada, Соединенные Штаты, 89509
    - Radiation Oncology Associates
- New Jersey
  - Hackensack, New Jersey, Соединенные Штаты, 07601
    - Hackensack University Medical Center
  - Lakewood, New Jersey, Соединенные Штаты, 08701
    - Monmouth Medical Center Southern Campus
  - Long Branch, New Jersey, Соединенные Штаты, 07740
    - Monmouth Medical Center
  - Morristown, New Jersey, Соединенные Штаты, 07960
    - Morristown Medical Center
  - New Brunswick, New Jersey, Соединенные Штаты, 08903
    - Rutgers Cancer Institute of New Jersey
  - New Brunswick, New Jersey, Соединенные Штаты, 08903
    - Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
- New Mexico
  - Albuquerque, New Mexico, Соединенные Штаты, 87106
    - University of New Mexico Cancer Center
- New York
  - Albany, New York, Соединенные Штаты, 12208
    - Albany Medical Center
  - Buffalo, New York, Соединенные Штаты, 14263
    - Roswell Park Cancer Institute
  - New York, New York, Соединенные Штаты, 10065
    - Memorial Sloan Kettering Cancer Center
  - New York, New York, Соединенные Штаты, 10029
    - Mount Sinai Hospital
  - New York, New York, Соединенные Штаты, 10032
    - NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
  - New York, New York, Соединенные Штаты, 10065
    - NYP/Weill Cornell Medical Center
  - New York, New York, Соединенные Штаты, 10016
    - Laura and Isaac Perlmutter Cancer Center at NYU Langone
  - Stony Brook, New York, Соединенные Штаты, 11794
    - Stony Brook University Medical Center
  - Syracuse, New York, Соединенные Штаты, 13210
    - State University of New York Upstate Medical University
  - The Bronx, New York, Соединенные Штаты, 10467
    - Montefiore Medical Center - Moses Campus
- North Carolina
  - Chapel Hill, North Carolina, Соединенные Штаты, 27599
    - UNC Lineberger Comprehensive Cancer Center
  - Charlotte, North Carolina, Соединенные Штаты, 28203
    - Carolinas Medical Center/Levine Cancer Institute
  - Clinton, North Carolina, Соединенные Штаты, 28328
    - Southeastern Medical Oncology Center-Clinton
  - Goldsboro, North Carolina, Соединенные Штаты, 27534
    - Southeastern Medical Oncology Center-Goldsboro
  - Goldsboro, North Carolina, Соединенные Штаты, 27534
    - Wayne Memorial Hospital
  - Jacksonville, North Carolina, Соединенные Штаты, 28546
    - Southeastern Medical Oncology Center-Jacksonville
  - Jacksonville, North Carolina, Соединенные Штаты, 28546
    - Onslow Memorial Hospital
- North Dakota
  - Fargo, North Dakota, Соединенные Штаты, 58103
    - Essentia Health Cancer Center-South University Clinic
  - Jamestown, North Dakota, Соединенные Штаты, 58401
    - Essentia Health - Jamestown Clinic
- Ohio
  - Akron, Ohio, Соединенные Штаты, 44308
    - Children's Hospital Medical Center of Akron
  - Cincinnati, Ohio, Соединенные Штаты, 45229
    - Cincinnati Children's Hospital Medical Center
  - Cincinnati, Ohio, Соединенные Штаты, 45220
    - Good Samaritan Hospital - Cincinnati
  - Cincinnati, Ohio, Соединенные Штаты, 45242
    - Bethesda North Hospital
  - Cincinnati, Ohio, Соединенные Штаты, 45247
    - TriHealth Cancer Institute-Westside
  - Cincinnati, Ohio, Соединенные Штаты, 45255
    - TriHealth Cancer Institute-Anderson
  - Cleveland, Ohio, Соединенные Штаты, 44109
    - MetroHealth Medical Center
  - Columbus, Ohio, Соединенные Штаты, 43205
    - Nationwide Children's Hospital
- Oklahoma
  - Lawton, Oklahoma, Соединенные Штаты, 73505
    - Cancer Centers of Southwest Oklahoma Research
  - Oklahoma City, Oklahoma, Соединенные Штаты, 73104
    - University of Oklahoma Health Sciences Center
  - Oklahoma City, Oklahoma, Соединенные Штаты, 73120
    - Mercy Hospital Oklahoma City
  - Tulsa, Oklahoma, Соединенные Штаты, 74146
    - Oklahoma Cancer Specialists and Research Institute-Tulsa
- Oregon
  - Baker City, Oregon, Соединенные Штаты, 97814
    - Saint Alphonsus Cancer Care Center-Baker City
  - Bend, Oregon, Соединенные Штаты, 97701
    - Saint Charles Health System
  - Clackamas, Oregon, Соединенные Штаты, 97015
    - Clackamas Radiation Oncology Center
  - Clackamas, Oregon, Соединенные Штаты, 97015
    - Providence Cancer Institute Clackamas Clinic
  - Coos Bay, Oregon, Соединенные Штаты, 97420
    - Bay Area Hospital
  - Newberg, Oregon, Соединенные Штаты, 97132
    - Providence Newberg Medical Center
  - Ontario, Oregon, Соединенные Штаты, 97914
    - Saint Alphonsus Cancer Care Center-Ontario
  - Oregon City, Oregon, Соединенные Штаты, 97045
    - Providence Willamette Falls Medical Center
  - Portland, Oregon, Соединенные Штаты, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, Соединенные Штаты, 97225
    - Providence Saint Vincent Medical Center
  - Redmond, Oregon, Соединенные Штаты, 97756
    - Saint Charles Health System-Redmond
- Pennsylvania
  - Hershey, Pennsylvania, Соединенные Штаты, 17033-0850
    - Penn State Milton S Hershey Medical Center
  - Philadelphia, Pennsylvania, Соединенные Штаты, 19111
    - Fox Chase Cancer Center
  - Philadelphia, Pennsylvania, Соединенные Штаты, 19104
    - Children's Hospital of Philadelphia
  - Philadelphia, Pennsylvania, Соединенные Штаты, 19104
    - University of Pennsylvania/Abramson Cancer Center
- South Carolina
  - Boiling Springs, South Carolina, Соединенные Штаты, 29316
    - Prisma Health Cancer Institute - Spartanburg
  - Columbia, South Carolina, Соединенные Штаты, 29203
    - Prisma Health Richland Hospital
  - Easley, South Carolina, Соединенные Штаты, 29640
    - Prisma Health Cancer Institute - Easley
  - Greenville, South Carolina, Соединенные Штаты, 29605
    - Prisma Health Cancer Institute - Faris
  - Greenville, South Carolina, Соединенные Штаты, 29607
    - Saint Francis Cancer Center
  - Greenville, South Carolina, Соединенные Штаты, 29615
    - Prisma Health Cancer Institute - Eastside
  - Greenville, South Carolina, Соединенные Штаты, 29605
    - Prisma Health Cancer Institute - Butternut
  - Greenville, South Carolina, Соединенные Штаты, 29601
    - Saint Francis Hospital
  - Greenville, South Carolina, Соединенные Штаты, 29605
    - BI-LO Charities Children's Cancer Center
  - Greenville, South Carolina, Соединенные Штаты, 29605
    - Prisma Health Greenville Memorial Hospital
  - Greer, South Carolina, Соединенные Штаты, 29650
    - Prisma Health Cancer Institute - Greer
  - Seneca, South Carolina, Соединенные Штаты, 29672
    - Prisma Health Cancer Institute - Seneca
- Tennessee
  - Chattanooga, Tennessee, Соединенные Штаты, 37404
    - Memorial Hospital
  - Hixson, Tennessee, Соединенные Штаты, 37343
    - Pulmonary Medicine Center of Chattanooga-Hixson
  - Knoxville, Tennessee, Соединенные Штаты, 37916
    - East Tennessee Childrens Hospital
  - Memphis, Tennessee, Соединенные Штаты, 38105
    - Saint Jude Children's Research Hospital
  - Nashville, Tennessee, Соединенные Штаты, 37232
    - Vanderbilt University/Ingram Cancer Center
  - Nashville, Tennessee, Соединенные Штаты, 37203
    - The Children's Hospital at TriStar Centennial
  - Ooltewah, Tennessee, Соединенные Штаты, 37363
    - Memorial GYN Plus
- Texas
  - Austin, Texas, Соединенные Штаты, 78723
    - Dell Children's Medical Center of Central Texas
  - Bryan, Texas, Соединенные Штаты, 77802
    - Saint Joseph Regional Cancer Center
  - Corpus Christi, Texas, Соединенные Штаты, 78411
    - Driscoll Children's Hospital
  - El Paso, Texas, Соединенные Штаты, 79905
    - El Paso Children's Hospital
  - Fort Worth, Texas, Соединенные Штаты, 76104
    - Cook Children's Medical Center
  - San Antonio, Texas, Соединенные Штаты, 78207
    - Children's Hospital of San Antonio
- Utah
  - American Fork, Utah, Соединенные Штаты, 84003
    - American Fork Hospital / Huntsman Intermountain Cancer Center
  - Cedar City, Utah, Соединенные Штаты, 84720
    - Sandra L Maxwell Cancer Center
  - Logan, Utah, Соединенные Штаты, 84321
    - Logan Regional Hospital
  - Murray, Utah, Соединенные Штаты, 84107
    - Intermountain Medical Center
  - Ogden, Utah, Соединенные Штаты, 84403
    - McKay-Dee Hospital Center
  - Riverton, Utah, Соединенные Штаты, 84065
    - Riverton Hospital
  - Salt Lake City, Utah, Соединенные Штаты, 84106
    - Utah Cancer Specialists-Salt Lake City
  - Salt Lake City, Utah, Соединенные Штаты, 84143
    - LDS Hospital
  - St. George, Utah, Соединенные Штаты, 84770
    - Saint George Regional Medical Center
- Virginia
  - Norfolk, Virginia, Соединенные Штаты, 23507
    - Children's Hospital of The King's Daughters
- Washington
  - Aberdeen, Washington, Соединенные Штаты, 98520
    - Providence Regional Cancer System-Aberdeen
  - Auburn, Washington, Соединенные Штаты, 98001
    - MultiCare Auburn Medical Center
  - Bellevue, Washington, Соединенные Штаты, 98004
    - Overlake Medical Center
  - Bellingham, Washington, Соединенные Штаты, 98225
    - PeaceHealth Saint Joseph Medical Center
  - Burien, Washington, Соединенные Штаты, 98166
    - Saint Anne Hospital
  - Centralia, Washington, Соединенные Штаты, 98531
    - Providence Regional Cancer System-Centralia
  - Edmonds, Washington, Соединенные Штаты, 98026
    - Swedish Cancer Institute-Edmonds
  - Enumclaw, Washington, Соединенные Штаты, 98022
    - Saint Elizabeth Hospital
  - Everett, Washington, Соединенные Штаты, 98201
    - Providence Regional Cancer Partnership
  - Federal Way, Washington, Соединенные Штаты, 98003
    - Saint Francis Hospital
  - Gig Harbor, Washington, Соединенные Штаты, 98335
    - MultiCare Gig Harbor Medical Park
  - Issaquah, Washington, Соединенные Штаты, 98029
    - Swedish Cancer Institute-Issaquah
  - Kennewick, Washington, Соединенные Штаты, 99336
    - Kadlec Clinic Hematology and Oncology
  - Lacey, Washington, Соединенные Штаты, 98503
    - Providence Regional Cancer System-Lacey
  - Lakewood, Washington, Соединенные Штаты, 98499
    - Saint Clare Hospital
  - Longview, Washington, Соединенные Штаты, 98632
    - PeaceHealth Saint John Medical Center
  - Port Townsend, Washington, Соединенные Штаты, 98368
    - Jefferson Healthcare
  - Poulsbo, Washington, Соединенные Штаты, 98370
    - Harrison HealthPartners Hematology and Oncology-Poulsbo
  - Puyallup, Washington, Соединенные Штаты, 98372
    - MultiCare Good Samaritan Hospital
  - Renton, Washington, Соединенные Штаты, 98055
    - Valley Medical Center
  - Seattle, Washington, Соединенные Штаты, 98105
    - Seattle Children's Hospital
  - Seattle, Washington, Соединенные Штаты, 98107
    - Swedish Medical Center-Ballard Campus
  - Seattle, Washington, Соединенные Штаты, 98122
    - Swedish Medical Center-First Hill
  - Seattle, Washington, Соединенные Штаты, 98112
    - Kaiser Permanente Washington
  - Seattle, Washington, Соединенные Штаты, 98104
    - Pacific Gynecology Specialists
  - Seattle, Washington, Соединенные Штаты, 98122-5711
    - Swedish Medical Center-Cherry Hill
  - Sedro-Woolley, Washington, Соединенные Штаты, 98284
    - PeaceHealth United General Medical Center
  - Shelton, Washington, Соединенные Штаты, 98584
    - Providence Regional Cancer System-Shelton
  - Silverdale, Washington, Соединенные Штаты, 98383
    - Saint Joseph Medical Center Hematology and Oncology - Silverdale
  - Spokane, Washington, Соединенные Штаты, 99204
    - Providence Sacred Heart Medical Center and Children's Hospital
  - Spokane, Washington, Соединенные Штаты, 99204
    - MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
  - Spokane, Washington, Соединенные Штаты, 99218
    - MultiCare Deaconess Cancer and Blood Specialty Center - North
  - Spokane Valley, Washington, Соединенные Штаты, 99216
    - MultiCare Deaconess Cancer and Blood Specialty Center - Valley
  - Tacoma, Washington, Соединенные Штаты, 98405
    - Mary Bridge Children's Hospital and Health Center
  - Tacoma, Washington, Соединенные Штаты, 98405
    - Northwest Medical Specialties PLLC
  - Tacoma, Washington, Соединенные Штаты, 98431
    - Madigan Army Medical Center
  - Tacoma, Washington, Соединенные Штаты, 98405
    - MultiCare Tacoma General Hospital
  - Tacoma, Washington, Соединенные Штаты, 98405
    - Franciscan Research Center-Northwest Medical Plaza
  - Vancouver, Washington, Соединенные Штаты, 98664
    - PeaceHealth Southwest Medical Center
  - Walla Walla, Washington, Соединенные Штаты, 99362
    - Providence Saint Mary Regional Cancer Center
  - Yakima, Washington, Соединенные Штаты, 98902
    - North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
  - Yelm, Washington, Соединенные Штаты, 98597
    - Providence Regional Cancer System-Yelm
- West Virginia
  - Bridgeport, West Virginia, Соединенные Штаты, 26330
    - United Hospital Center
  - Martinsburg, West Virginia, Соединенные Штаты, 25401
    - WVUH-Berkely Medical Center
  - Morgantown, West Virginia, Соединенные Штаты, 26506
    - West Virginia University Healthcare
  - Parkersburg, West Virginia, Соединенные Штаты, 26101
    - Camden Clark Medical Center
- Wisconsin
  - Ashland, Wisconsin, Соединенные Штаты, 54806
    - Duluth Clinic Ashland
  - Ashland, Wisconsin, Соединенные Штаты, 54806
    - Northwest Wisconsin Cancer Center
  - Burlington, Wisconsin, Соединенные Штаты, 53105
    - Aurora Cancer Care-Southern Lakes VLCC
  - Chippewa Falls, Wisconsin, Соединенные Штаты, 54729
    - Marshfield Clinic-Chippewa Center
  - Eau Claire, Wisconsin, Соединенные Штаты, 54701
    - Marshfield Medical Center-EC Cancer Center
  - Fond du Lac, Wisconsin, Соединенные Штаты, 54937
    - Aurora Health Center-Fond du Lac
  - Germantown, Wisconsin, Соединенные Штаты, 53022
    - Aurora Health Care Germantown Health Center
  - Grafton, Wisconsin, Соединенные Штаты, 53024
    - Aurora Cancer Care-Grafton
  - Green Bay, Wisconsin, Соединенные Штаты, 54311
    - Aurora BayCare Medical Center
  - Kenosha, Wisconsin, Соединенные Штаты, 53142
    - Aurora Cancer Care-Kenosha South
  - La Crosse, Wisconsin, Соединенные Штаты, 54601
    - Gundersen Lutheran Medical Center
  - Ladysmith, Wisconsin, Соединенные Штаты, 54848
    - Marshfield Medical Center - Ladysmith
  - Madison, Wisconsin, Соединенные Штаты, 53792
    - University of Wisconsin Carbone Cancer Center - University Hospital
  - Marinette, Wisconsin, Соединенные Штаты, 54143
    - Aurora Bay Area Medical Group-Marinette
  - Marshfield, Wisconsin, Соединенные Штаты, 54449
    - Marshfield Medical Center-Marshfield
  - Milwaukee, Wisconsin, Соединенные Штаты, 53226
    - Medical College of Wisconsin
  - Milwaukee, Wisconsin, Соединенные Штаты, 53209
    - Aurora Cancer Care-Milwaukee
  - Milwaukee, Wisconsin, Соединенные Штаты, 53215
    - Aurora Saint Luke's Medical Center
  - Milwaukee, Wisconsin, Соединенные Штаты, 53233
    - Aurora Sinai Medical Center
  - Minocqua, Wisconsin, Соединенные Штаты, 54548
    - Marshfield Medical Center - Minocqua
  - Oshkosh, Wisconsin, Соединенные Штаты, 54904
    - Vince Lombardi Cancer Clinic - Oshkosh
  - Racine, Wisconsin, Соединенные Штаты, 53406
    - Aurora Cancer Care-Racine
  - Rice Lake, Wisconsin, Соединенные Штаты, 54868
    - Marshfield Medical Center-Rice Lake
  - Sheboygan, Wisconsin, Соединенные Штаты, 53081
    - Vince Lombardi Cancer Clinic-Sheboygan
  - Stevens Point, Wisconsin, Соединенные Штаты, 54482
    - Marshfield Medical Center-River Region at Stevens Point
  - Summit, Wisconsin, Соединенные Штаты, 53066
    - Aurora Medical Center in Summit
  - Two Rivers, Wisconsin, Соединенные Штаты, 54241
    - Vince Lombardi Cancer Clinic-Two Rivers
  - Wausau, Wisconsin, Соединенные Штаты, 54401
    - Marshfield Clinic-Wausau Center
  - Wauwatosa, Wisconsin, Соединенные Штаты, 53226
    - Aurora Cancer Care-Milwaukee West
  - West Allis, Wisconsin, Соединенные Штаты, 53227
    - Aurora West Allis Medical Center
  - Weston, Wisconsin, Соединенные Штаты, 54476
    - Marshfield Medical Center - Weston
  - Wisconsin Rapids, Wisconsin, Соединенные Штаты, 54494
    - Marshfield Clinic - Wisconsin Rapids Center
- Wyoming
  - Cheyenne, Wyoming, Соединенные Штаты, 82001
    - Cheyenne Regional Medical Center-West
  - Cody, Wyoming, Соединенные Штаты, 82414
    - Billings Clinic-Cody
  - Sheridan, Wyoming, Соединенные Штаты, 82801
    - Welch Cancer Center

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

12 лет и старше (Ребенок, Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

PHASE I (ARMS A, B, C, D, E, F, G, H, I, X, Y, Z)
Age >= 18 years
Patients must have pathologically confirmed relapsed or refractory classical Hodgkin lymphoma (cHL); a biopsy at any relapse is acceptable; other histologies including lymphocyte predominant (LP) HL are not permitted
Patients must have relapsed after first line chemotherapy; may have relapsed after autologous or allogeneic stem cell transplant, or have primary refractory disease; no upper limit for number of prior therapies; if status post allogeneic stem cell transplant, no active graft versus host disease
Patients may have received prior brentuximab vedotin, but must not have received brentuximab vedotin within 6 months prior to registration, and must not have relapsed within 6 months of receiving previous brentuximab vedotin; patients may not have received prior nivolumab or PD1/PDL1 axis agents; patients in the nivolumab/brentuximab cohorts ONLY (D, E, F, Y) may have received prior ipilimumab
Patients may have received other prior activating immunotherapies (i.e. checkpoint inhibitors), but must not have received them within 6 months prior to registration, and there must be no serious unresolved complication of therapy at the time of registration; for the purposes of this study monoclonal antibodies and antibody drug conjugates are not considered to be activating immunotherapies and there are no additional time restrictions on prior exposure to these agents (except prior brentuximab vedotin)
Eastern Cooperative Oncology Group (ECOG)-American College of Radiology Imaging Network (ACRIN) performance status between 0-2
Patients must have measurable disease; baseline measurements and evaluations must be obtained within 4 weeks of registration to the study; abnormal PET scans will not constitute evaluable disease unless verified by a diagnostic quality CT scan; patients must use the same imaging modality (CT or PET/CT) throughout the study
Patient must not be pregnant or breast-feeding due to risk of fetal harm by the chemotherapeutic agents prescribed in this protocol; all patients of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a patient of childbearing potential is anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Patient of childbearing potential and/or sexually active patients must either abstain from sexual intercourse for the duration of their participation in the study or agree to use both single barrier contraception and birth control pills or implants for at least one week prior to the start of the study drug and continuing for 5 months after the last dose of study drug (for patients of childbearing potential) and for 7 months after the last dose of study drug (for patients who are sexually active with anyone of childbearing potential); should a patient become pregnant or suspect pregnancy while the patient or their partner is participating in this study, the patient (or the participating partner) should inform the treating physician immediately
Patients must have no evidence of dyspnea at rest and a pulse oximetry > 92% while breathing room air
Patients must have forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) > 60% by pulmonary function test (PFT), unless due to large mediastinal mass from HL; carbon monoxide diffusion capacity (DLCO), FEV1, and FVC all > 50% predicted value; all pulmonary function tests must be obtained within one month prior to registration
Absolute neutrophil count (ANC) >= 1500/mcL (1.5 x 10^9/L) (obtained within 2 weeks prior to registration)
Platelets >= 75,000/mcL (75 x 10^9/L) (obtained within 2 weeks prior to registration)
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN) (obtained within 2 weeks prior to registration)
Bilirubin =< 2 x upper limit of normal (ULN) (unless documented Gilbert's syndrome, for which bilirubin =< 3 x upper limit of normal [ULN] is permitted) (obtained within 2 weeks prior to registration)
Calculated creatinine clearance by Cockcroft-Gault formula >= 30 ml/min (obtained within 2 weeks prior to registration)
No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma or any surgically- or radiation-cured malignancy continuously disease free for >= 5 years so as not to interfere with interpretation of radiographic response
Patient must have no current or prior history of central nervous system (CNS) involvement
All prior therapy must have been completed at least 21 days prior to enrollment; no concomitant anti lymphoma therapy, including systemic corticosteroids for the purpose of treatment of lymphoma are allowed; topical steroids are allowed
No history of Steven's Johnson's syndrome, toxic epidermal necrolysis (TEN)s syndrome, or motor neuropathy
Human immunodeficiency virus (HIV) positive patients are allowed on this study if they have a CD4 count > 400, and are on a stable antiviral regimen; patients with poorly controlled HIV or other chronic active viral infections will be excluded
Patients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (i.e., prednisone, dexamethasone) or continuous use of topical steroid creams or ointments or ophthalmologic steroids; a history of occasional (but not continuous) use of steroid inhalers is allowed
- Replacement doses of steroids for patients with adrenal insufficiency are allowed; patients who discontinue use of these classes of medication for at least 2 weeks prior to initiation of study treatment are eligible if, in the judgment of the treating physician investigator, the patient is not likely to require resumption of treatment with these classes of drugs during the study
- Exclusion from this study also includes patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjogren's syndrome, autoimmune vasculitis [e.g., Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and Myasthenia Gravis); other CNS autoimmune disease (e.g., Multiple sclerosis); patients with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligible
Patients must not have grade 2 or greater peripheral sensory neuropathy
Patients must not have New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
Patients must not have previously existing hypersensitivity to brentuximab vedotin or ipilimumab
Patients must not have a serious medical or psychiatric illness likely to interfere with study participation
Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration
Routine vaccinations, including seasonal influenza, should be given at least 2 weeks prior to study treatment; vaccines are not prohibited on study, but must be given at least 6 weeks after cycle 1 and not within 7 days of treatment
Patients registering to Arms D, E, F, G, H, I, X, Y must not currently be smoking tobacco or other substances and must not have smoked within the past 6 months
RANDOMIZED PHASE II (ARMS K AND L): Age >= 12 years
- Pediatric patients will include any patients < 18 years of age
RANDOMIZED PHASE II (ARMS K AND L): Patients must have pathologically confirmed relapsed or refractory classical Hodgkin lymphoma (cHL); a biopsy at any relapse is acceptable; other histologies including lymphocyte predominant (LP) HL are not permitted
RANDOMIZED PHASE II (ARMS K AND L): Patients must have relapsed after first line chemotherapy; may have relapsed after autologous stem cell transplant, or have primary refractory disease; no upper limit for number of prior therapies; patient must not have received a prior allogeneic stem cell transplant (out of risk of reactivation of pulmonary graft versus host disease [GVHD])
RANDOMIZED PHASE II (ARMS K AND L): Patients may have received prior brentuximab vedotin, but must not have received brentuximab vedotin within 6 months prior to registration, and must not have relapsed within 6 months of receiving previous brentuximab vedotin; patients may not have received prior nivolumab or PD1/PDL1 axis agents; patients may not have received prior ipilimumab
RANDOMIZED PHASE II (ARMS K AND L): Patients may not have received other prior activating immunotherapies (i.e. checkpoint inhibitor therapies); for the purposes of this study monoclonal antibodies and antibody drug conjugates are not considered to be activating immunotherapies and there are no additional time restrictions on prior exposure to these agents (except prior brentuximab vedotin)
RANDOMIZED PHASE II (ARMS K AND L): Adult patient (>= 18 years of age) ECOG-ACRIN performance status between 0-2
- Pediatric patients (16-17 years of age) must have a Karnofsky performance level >= 50%
- Pediatric patients (12-15 years of age) must have a Lansky performance level >= 50
RANDOMIZED PHASE II (ARMS K AND L): Patients must have measurable disease; baseline measurements and evaluations must be obtained within 4 weeks of registration to the study; abnormal PET scans will not constitute evaluable disease unless verified by a diagnostic quality CT scan; patients must use the same imaging modality (CT or PET/CT) throughout the study
RANDOMIZED PHASE II (ARMS K AND L): Patient must not be pregnant or breast-feeding due to risk of fetal harm by the chemotherapeutic agents prescribed in this protocol; all patients of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
RANDOMIZED PHASE II (ARMS K AND L): Patient of childbearing potential and/or sexually active patient must either abstain from sexual intercourse for the duration of their participation in the study or agree to use both double barrier contraception and birth control pills or implants for at least one week prior to the start of the study drug and continuing for 5 months after the last dose of study drug (for patients of childbearing potential) and for 7 months after the last dose of study drug (for patients who are sexually active with anyone of childbearing potential); should a patient become pregnant or suspect pregnancy while the patient or their partner is participating in this study, the patient (or the participating partner) should inform the treating physician immediately
RANDOMIZED PHASE II (ARMS K AND L): Patients with impaired decision-making capacity are eligible with legally authorized representative
RANDOMIZED PHASE II (ARMS K AND L): Patients must have no evidence of dyspnea at rest and a pulse oximetry > 92% while breathing room air
RANDOMIZED PHASE II (ARMS K AND L): Patients must have FEV1/FVC > 60% by pulmonary function test (PFT), unless due to large mediastinal mass from HL; carbon monoxide diffusion capacity (DLCO), FEV1, and FVC all > 50% predicted value; all pulmonary function tests must be obtained within one month prior to registration
RANDOMIZED PHASE II (ARMS K AND L): ANC >= 1500/mcL (1.5 x 0^9/L) (obtained within 2 weeks prior to registration)
RANDOMIZED PHASE II (ARMS K AND L): Platelets >= 75,000/mcL (75 x 10^9/L) (obtained within 2 weeks prior to registration)
RANDOMIZED PHASE II (ARMS K AND L): AST/ALT =< 2.5 x upper limit of normal (ULN) for age (obtained within 2 weeks prior to registration)
RANDOMIZED PHASE II (ARMS K AND L): Bilirubin =< 2 x upper limit of normal (ULN) (unless documented Gilbert's syndrome, for which bilirubin =< 3 x upper limit of normal [ULN] is permitted) (obtained within 2 weeks prior to registration)
RANDOMIZED PHASE II (ARMS K AND L): Adult patients (>= 18 years old) must have a calculated creatinine clearance by Cockcroft-Gault formula >= 30 ml/min (obtained within 2 weeks prior to registration)
RANDOMIZED PHASE II (ARMS K AND L): Pediatric patients (< 18 years old) must have a creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or serum creatinine based on age/sex as follows:
- Age: maximum serum creatinine (mg/dL)
  - < 13 years: male (1.2), female (1.2)
  - 13 to < 16 years: male (1.5), female (1.4)
  - >= 16 years: male (1.7), female (1.4)
RANDOMIZED PHASE II (ARMS K AND L): No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma or any surgically- or radiation-cured malignancy continuously disease free for >= 5 years so as not to interfere with interpretation of radiographic response
RANDOMIZED PHASE II (ARMS K AND L): Patient must have no current or prior history of CNS involvement
RANDOMIZED PHASE II (ARMS K AND L): All prior therapy must have been completed at least 21 days prior to enrollment (6 weeks for nitrosoureas or mitomycin C); no concomitant anti lymphoma therapy, including systemic corticosteroids for the purpose of treatment of lymphoma are allowed; topical steroids are allowed
RANDOMIZED PHASE II (ARMS K AND L): No history of Steven's Johnson's syndrome, TENs syndrome, or motor neuropathy
RANDOMIZED PHASE II (ARMS K AND L): HIV positive patients are eligible provided they meet the other protocol criteria including the following:
- Long term survival expected were it not for the cHL
- HIV viral loads undetectable by standard clinical HIV testing
- Willing to adhere to effective combination antiretroviral therapy
RANDOMIZED PHASE II (ARMS K AND L): Patients must not have autoimmune disorders, prior solid organ transplant, or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (i.e., prednisone, dexamethasone) or continuous use of topical steroid creams or ointments or ophthalmologic steroids; a history of occasional (but not continuous) use of steroid inhalers is allowed; replacement doses of steroids for patients with adrenal insufficiency are allowed; patients who discontinue use of steroid medication for at least 2 weeks prior to initiation of therapy are eligible if, in the judgment of the treating physician investigator, the patient is not likely to require resumption of treatment with these classes of drugs during the study; exclusion from this study also includes patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjogren's syndrome, autoimmune vasculitis [e.g., Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and Myasthenia Gravis); other CNS autoimmune disease (e.g., Multiple sclerosis); patients with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligible
RANDOMIZED PHASE II (ARMS K AND L): Patients must not have grade 2 or greater peripheral sensory neuropathy
RANDOMIZED PHASE II (ARMS K AND L): Patients must not have NYHA class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
RANDOMIZED PHASE II (ARMS K AND L): Patients must not have previously existing hypersensitivity to brentuximab vedotin or ipilimumab
RANDOMIZED PHASE II (ARMS K AND L): Patients must not have a serious medical or psychiatric illness likely to interfere with study participation
RANDOMIZED PHASE II (ARMS K AND L): Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration
RANDOMIZED PHASE II (ARMS K AND L): Routine vaccinations, including seasonal influenza, should be given at least 2 weeks prior to study treatment; vaccines are not prohibited on study, but must be given at least 6 weeks after cycle 1 and not within 7 days of treatment
RANDOMIZED PHASE II (ARMS K AND L): Patients must not currently be smoking tobacco or other agents; vaping is not allowed
RANDOMIZED PHASE II (ARMS K AND L): Patients must not have a history of or evidence of cardiovascular risks including any of the following:
- QT interval corrected for heart rate using the Bazett's formula QTcB >= 480 msec at baseline
- History of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty, or stenting within the past 24 weeks prior to registration
- History prior to registration or evidence of current >= class II congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system
- Left ventricular ejection fraction (LVEF) =< lower limit of normal on cardiac echocardiogram (echo) or multigated acquisition scan (MUGA)
- Intra-cardiac defibrillator
- History of abnormal cardiac valve morphology (>= grade 2) documented by ECHO; (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study); subjects with moderate valvular thickening should not be entered on study
- History or evidence of current clinically significant uncontrolled cardiac arrhythmias; clarification: subjects with atrial fibrillation controlled for > 30 days prior to dosing are eligible
- Treatment refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mm Hg which cannot be controlled by anti-hypertensive therapy

Учебный план

В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Основная цель: Уход
Распределение: Рандомизированный
Интервенционная модель: Параллельное назначение
Маскировка: Нет (открытая этикетка)

Количество рук

Оружие и интервенции

Группа участников / Армия	Вмешательство/лечение
Экспериментальный: Phase I Arm I (brentuximab vedotin, ipilimumab) Patients receive brentuximab vedotin IV over 30 minutes on day 1 of cycles 1-16 and ipilimumab IV over 90 minutes on day 1 of cycles 1-4, 8, 12, and 16. Treatment repeats every 21 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or PET scan throughout the trial. Patients undergo blood sample collection and may undergo tumor biopsy on study.	Биологический: Ipilimumab Given IV Другие имена: Моноклональное антитело против цитотоксического антигена-4, ассоциированного с Т-лимфоцитами БМС-734016 Биоаналог ипилимумаба CS1002 МДС-010 MDX-CTLA4 Ервой MDX010 БМС734016 БМС 734016 МДКС 010 Процедура: Computed Tomography Undergo CT Другие имена: КТ КОШКА Томография Компьютерная аксиальная томография Компьютеризированная аксиальная томография Компьютерная томография томография Компьютерная аксиальная томография (процедура) Компьютерная томография (КТ) Диагностическое сканирование кошек Диагностический тип службы сканирования кошек Процедура: Biopsy Procedure Undergo biopsy Другие имена: Вх БИОПСИ_ТИП Биопсия Процедура: Biospecimen Collection Undergo collection of blood Другие имена: Сбор биологических образцов Собран биообразец Сбор образцов Образцы коллекции Лекарство: Brentuximab Vedotin Given IV Другие имена: Адсетрис СГН-35 cAC10-vcMMAE АЦП СГН-35 Конъюгат анти-CD30 антитело-лекарственное средство SGN-35 Моноклональное антитело к CD30-MMAE SGN-35 Моноклональное антитело к CD30-монометилауристатин E SGN-35 SGN35 СГН 35 Процедура: Positron Emission Tomography Undergo PET Другие имена: Медицинская визуализация, позитронно-эмиссионная томография ДОМАШНИЙ ПИТОМЕЦ ПЭТ сканирование Позитронно-эмиссионная томография ПТ Позитронно-эмиссионная томография (процедура)
Экспериментальный: Phase I Arm II (brentuximab vedotin, nivolumab) Patients receive brentuximab vedotin IV over 90 minutes on day 1 of cycles 1-16 and nivolumab IV over 30 minutes on day 1 of cycles 1-46. Treatment repeats every 21 days for up to 16 cycles and every 14 days beginning cycle 17 for up to 46 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or PET scan throughout the trial. Patients undergo blood sample collection and may undergo tumor biopsy on study.	Процедура: Computed Tomography Undergo CT Другие имена: КТ КОШКА Томография Компьютерная аксиальная томография Компьютеризированная аксиальная томография Компьютерная томография томография Компьютерная аксиальная томография (процедура) Компьютерная томография (КТ) Диагностическое сканирование кошек Диагностический тип службы сканирования кошек Процедура: Biopsy Procedure Undergo biopsy Другие имена: Вх БИОПСИ_ТИП Биопсия Процедура: Biospecimen Collection Undergo collection of blood Другие имена: Сбор биологических образцов Собран биообразец Сбор образцов Образцы коллекции Лекарство: Brentuximab Vedotin Given IV Другие имена: Адсетрис СГН-35 cAC10-vcMMAE АЦП СГН-35 Конъюгат анти-CD30 антитело-лекарственное средство SGN-35 Моноклональное антитело к CD30-MMAE SGN-35 Моноклональное антитело к CD30-монометилауристатин E SGN-35 SGN35 СГН 35 Процедура: Positron Emission Tomography Undergo PET Другие имена: Медицинская визуализация, позитронно-эмиссионная томография ДОМАШНИЙ ПИТОМЕЦ ПЭТ сканирование Позитронно-эмиссионная томография ПТ Позитронно-эмиссионная томография (процедура) Биологический: Nivolumab Given IV Другие имена: БМС-936558 МДС-1106 НИВО ОНО-4538 Опдиво CMAB819 Биоаналог ниволумаба CMAB819 Многомерный код 1106 MDX1106 БМС 936558 АБП 206 Ниволумаб Биоаналог ABP 206 БКД-263 Ниволумаб Биоаналог BCD-263 БМС936558 ОНО 4538 ОНО4538
Экспериментальный: Phase I Arm III (brentuximab vedotin, nivolumab, ipilimumab) Patients receive brentuximab vedotin IV over 90 minutes on day 1 of cycles 1-16, nivolumab IV over 30 minutes on day 1 of cycles 1-46, and ipilimumab IV over 30 minutes on day 1 every 12 weeks for up to 9 doses. Treatment repeats every 21 days for up to 16 cycles and every 14 days beginning cycle 17 for up to 46 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or PET scan throughout the trial. Patients undergo blood sample collection and may undergo tumor biopsy on study.	Биологический: Ipilimumab Given IV Другие имена: Моноклональное антитело против цитотоксического антигена-4, ассоциированного с Т-лимфоцитами БМС-734016 Биоаналог ипилимумаба CS1002 МДС-010 MDX-CTLA4 Ервой MDX010 БМС734016 БМС 734016 МДКС 010 Процедура: Computed Tomography Undergo CT Другие имена: КТ КОШКА Томография Компьютерная аксиальная томография Компьютеризированная аксиальная томография Компьютерная томография томография Компьютерная аксиальная томография (процедура) Компьютерная томография (КТ) Диагностическое сканирование кошек Диагностический тип службы сканирования кошек Процедура: Biopsy Procedure Undergo biopsy Другие имена: Вх БИОПСИ_ТИП Биопсия Процедура: Biospecimen Collection Undergo collection of blood Другие имена: Сбор биологических образцов Собран биообразец Сбор образцов Образцы коллекции Лекарство: Brentuximab Vedotin Given IV Другие имена: Адсетрис СГН-35 cAC10-vcMMAE АЦП СГН-35 Конъюгат анти-CD30 антитело-лекарственное средство SGN-35 Моноклональное антитело к CD30-MMAE SGN-35 Моноклональное антитело к CD30-монометилауристатин E SGN-35 SGN35 СГН 35 Процедура: Positron Emission Tomography Undergo PET Другие имена: Медицинская визуализация, позитронно-эмиссионная томография ДОМАШНИЙ ПИТОМЕЦ ПЭТ сканирование Позитронно-эмиссионная томография ПТ Позитронно-эмиссионная томография (процедура) Биологический: Nivolumab Given IV Другие имена: БМС-936558 МДС-1106 НИВО ОНО-4538 Опдиво CMAB819 Биоаналог ниволумаба CMAB819 Многомерный код 1106 MDX1106 БМС 936558 АБП 206 Ниволумаб Биоаналог ABP 206 БКД-263 Ниволумаб Биоаналог BCD-263 БМС936558 ОНО 4538 ОНО4538
Экспериментальный: Phase II Arm I (brentuximab vedotin, nivolumab) Patients receive brentuximab vedotin IV over 90 minutes on day 1 of cycles 1-16 and nivolumab IV over 30 minutes on day 1 of cycles 1-34. Treatment repeats every 21 days for up to 34 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or PET scan throughout the trial. Patients undergo blood sample collection and may undergo tumor biopsy on study.	Процедура: Computed Tomography Undergo CT Другие имена: КТ КОШКА Томография Компьютерная аксиальная томография Компьютеризированная аксиальная томография Компьютерная томография томография Компьютерная аксиальная томография (процедура) Компьютерная томография (КТ) Диагностическое сканирование кошек Диагностический тип службы сканирования кошек Процедура: Biopsy Procedure Undergo biopsy Другие имена: Вх БИОПСИ_ТИП Биопсия Процедура: Biospecimen Collection Undergo collection of blood Другие имена: Сбор биологических образцов Собран биообразец Сбор образцов Образцы коллекции Лекарство: Brentuximab Vedotin Given IV Другие имена: Адсетрис СГН-35 cAC10-vcMMAE АЦП СГН-35 Конъюгат анти-CD30 антитело-лекарственное средство SGN-35 Моноклональное антитело к CD30-MMAE SGN-35 Моноклональное антитело к CD30-монометилауристатин E SGN-35 SGN35 СГН 35 Процедура: Positron Emission Tomography Undergo PET Другие имена: Медицинская визуализация, позитронно-эмиссионная томография ДОМАШНИЙ ПИТОМЕЦ ПЭТ сканирование Позитронно-эмиссионная томография ПТ Позитронно-эмиссионная томография (процедура) Биологический: Nivolumab Given IV Другие имена: БМС-936558 МДС-1106 НИВО ОНО-4538 Опдиво CMAB819 Биоаналог ниволумаба CMAB819 Многомерный код 1106 MDX1106 БМС 936558 АБП 206 Ниволумаб Биоаналог ABP 206 БКД-263 Ниволумаб Биоаналог BCD-263 БМС936558 ОНО 4538 ОНО4538
Экспериментальный: Phase II Arm II (brentuximab vedotin, nivolumab, ipilimumab) Patients receive brentuximab vedotin IV over 90 minutes on day 1 of cycles 1-16, nivolumab IV over 30 minutes on day 1 of cycles 1-34, and ipilimumab IV over 30 minutes on day 1 every 12 weeks for up to 9 doses. Treatment repeats every 21 days for up to 34 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or PET scan throughout the trial. Patients undergo blood sample collection and may undergo tumor biopsy on study.	Биологический: Ipilimumab Given IV Другие имена: Моноклональное антитело против цитотоксического антигена-4, ассоциированного с Т-лимфоцитами БМС-734016 Биоаналог ипилимумаба CS1002 МДС-010 MDX-CTLA4 Ервой MDX010 БМС734016 БМС 734016 МДКС 010 Процедура: Computed Tomography Undergo CT Другие имена: КТ КОШКА Томография Компьютерная аксиальная томография Компьютеризированная аксиальная томография Компьютерная томография томография Компьютерная аксиальная томография (процедура) Компьютерная томография (КТ) Диагностическое сканирование кошек Диагностический тип службы сканирования кошек Процедура: Biopsy Procedure Undergo biopsy Другие имена: Вх БИОПСИ_ТИП Биопсия Процедура: Biospecimen Collection Undergo collection of blood Другие имена: Сбор биологических образцов Собран биообразец Сбор образцов Образцы коллекции Лекарство: Brentuximab Vedotin Given IV Другие имена: Адсетрис СГН-35 cAC10-vcMMAE АЦП СГН-35 Конъюгат анти-CD30 антитело-лекарственное средство SGN-35 Моноклональное антитело к CD30-MMAE SGN-35 Моноклональное антитело к CD30-монометилауристатин E SGN-35 SGN35 СГН 35 Процедура: Positron Emission Tomography Undergo PET Другие имена: Медицинская визуализация, позитронно-эмиссионная томография ДОМАШНИЙ ПИТОМЕЦ ПЭТ сканирование Позитронно-эмиссионная томография ПТ Позитронно-эмиссионная томография (процедура) Биологический: Nivolumab Given IV Другие имена: БМС-936558 МДС-1106 НИВО ОНО-4538 Опдиво CMAB819 Биоаналог ниволумаба CMAB819 Многомерный код 1106 MDX1106 БМС 936558 АБП 206 Ниволумаб Биоаналог ABP 206 БКД-263 Ниволумаб Биоаналог BCD-263 БМС936558 ОНО 4538 ОНО4538

Что измеряет исследование?

Первичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Maximum tolerated dose (MTD) of each combination (Phase I) Временное ограничение: 21 days	MTD defined as the highest dose level at which less than 33% of 6 patients experience a dose limiting toxicity, will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Upon completion of the trial, frequency of subjects experiencing toxicities will be tabulated. Toxicities will be assessed and graded according to CTCAE version 4.0 terminology. Exact 95% confidence intervals (CI) around the toxicity proportions will be calculated.	21 days
CR rate (Phase II) Временное ограничение: Up to 10 years	The analysis of CR between two arms will be performed using exact Cochran-Mantel-Haenszel (CMH) test stratifying on prior brentuximab vedotin (BV) (yes versus [vs.] no) and age (< 18 vs. >= 18). Multivariable logistic regression modeling will be used to adjust for the effect of any covariates that are associated with these categorical outcomes.	Up to 10 years

Вторичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Complete response (CR) rate (Phase I) Временное ограничение: Up to 3 years	Assessed using the Revised Response Criteria for Malignant Lymphoma and reported along with the 95% CI.	Up to 3 years
Partial response (PR) rate (Phase I) Временное ограничение: Up to 3 years	Assessed using the Revised Response Criteria for Malignant Lymphoma and reported along with the 95% CI.	Up to 3 years
Overall response rate (ORR) rate (Phase I) Временное ограничение: Up to 3 years	Assessed using the Revised Response Criteria for Malignant Lymphoma and reported along with the 95% CI.	Up to 3 years
Duration of response (DOR) (Phase I) Временное ограничение: From the documented beginning of response up to 3 years	DOR will be estimated using Kaplan-Meier methodology. Greenwood's formula will be used to calculate 95% CI for the Kaplan-Meier estimates. Descriptive statistics will be used to evaluate the DOR achieved with the protocol therapy and with the most recent prior systemic therapy.	From the documented beginning of response up to 3 years
Overall survival (OS) (Phase I) Временное ограничение: From the date of study entry up to 3 years	OS will be estimated using Kaplan-Meier methodology. Greenwood's formula will be used to calculate 95% CI for the Kaplan-Meier estimates.	From the date of study entry up to 3 years
Progression-free survival (PFS) (Phase I) Временное ограничение: From entry onto study up to 3 years	PFS will be estimated using Kaplan-Meier methodology. Greenwood's formula will be used to calculate 95% CI for the Kaplan-Meier estimates.	From entry onto study up to 3 years
ORR (Phase II) Временное ограничение: Up to 10 years	Assessed using Revised Response (Cheson) and Deauville criteria. The analysis of ORR between two arms will be performed using the CMH test stratifying on prior BV (yes vs. no) and age (< 18 vs. >= 18). Multivariable logistic regression modeling will be used to adjust for the effect of any covariates that are associated with these categorical outcomes.	Up to 10 years
PFS (or modified PFS) (Phase II) Временное ограничение: From randomization up to 10 years	PFS will be estimated using Kaplan-Meier methodology and compared between arms using stratified log-rank test. Greenwood's formula will be used to calculate 95% confidence intervals for the Kaplan-Meier estimates. Cox proportional regression model will be used to estimate hazard ratios (95% CI) and assess the relationship between other prognostic factors with time-to-event outcome. Point estimates of all endpoints will be accompanied by the corresponding 95% confidence intervals.	From randomization up to 10 years
OS (Phase II) Временное ограничение: From randomization up to 10 years	OS will be estimated using Kaplan-Meier methodology and compared between arms using stratified log-rank test. Greenwood's formula will be used to calculate 95% confidence intervals for the Kaplan-Meier estimates. Cox proportional regression model will be used to estimate hazard ratios (95% CI) and assess the relationship between other prognostic factors with time-to-event outcome. Point estimates of all endpoints will be accompanied by the corresponding 95% confidence intervals.	From randomization up to 10 years
DOR (Phase II) Временное ограничение: From the documented beginning of response up to 10 years	DOR, will be estimated using Kaplan-Meier methodology and compared between arms using stratified log-rank test. Greenwood's formula will be used to calculate 95% confidence intervals for the Kaplan-Meier estimates. Cox proportional regression model will be used to estimate hazard ratios (95% CI) and assess the relationship between other prognostic factors with time-to-event outcome. Point estimates of all endpoints will be accompanied by the corresponding 90% confidence intervals. The DOR achieved with the most recent prior systemic therapy will be collected on the case report forms, and descriptive statistics will be used to evaluate the DOR achieved with the protocol therapy and with the most recent prior systemic therapy.	From the documented beginning of response up to 10 years

Другие показатели результатов

Мера результата	Мера Описание	Временное ограничение
Влияние комбинаций на системный иммунитет (фаза I и II) Временное ограничение: Исходный уровень до 6 недель после завершения исследуемого лечения		Исходный уровень до 6 недель после завершения исследуемого лечения
Change in the percentage of activated T cells and natural killer cells (Phase I and II) Временное ограничение: Baseline (Time 1) to 9 weeks (Time 3, time of first re-staging)	These quantities of interest will be calculated for each patient and the Wilcoxon signed-rank test will be used to test for significant difference between the time points. Using Wilcoxon rank sum test (two-sided type I error of 0.1), differences between those who progress or die within one year versus (vs.) those who are event-free at one year will be evaluated.	Baseline (Time 1) to 9 weeks (Time 3, time of first re-staging)
Change in the percentages of activated T cells and natural killer cells (Phase I and II) Временное ограничение: Day 1 of cycle 2 (Time 2) or 9 weeks (Time 3) to up to 6 weeks after completion of study treatment (Time 4, end of study)	These quantities of interest will be calculated for each patient and the Wilcoxon signed-rank test will be used to test for significant difference between the time points. Using the Wilcoxon rank sum test (two-sided type I error of 0.1), differences between those who progress or die within one year vs. those who are event-free at one year will be evaluated.	Day 1 of cycle 2 (Time 2) or 9 weeks (Time 3) to up to 6 weeks after completion of study treatment (Time 4, end of study)
Pre- and post-treatment levels of cytokines and T cell specific biomarkers (Phase I and II) Временное ограничение: Baseline to up to 6 weeks after completion of study treatment	Pre- and post-treatment levels of these markers will be compared using the Wilcoxon signed-rank test with two-sided type I error of 0.1. Marker levels between patients who fail at 1-year vs. patients who are event-free at 1-year will be evaluated. Given limited data, the analyses of PD-1, co-expression of Tim-3 with PD-1, ICOS, sCD30, galectin-1 and the peripheral blood absolute lymphocyte to monocyte ratio will be mainly exploratory and will be summarized descriptively at the time-points described above. The association with PFS will be explored.	Baseline to up to 6 weeks after completion of study treatment
Differentially expressed genes between two groups (patients who fail at 1-year vs. patients who are event-free at 1-year or responders vs. non-responders) (Phase I and II) Временное ограничение: 1 year	Assessed using gene expression profiling (GEP). Differentially expressed genes will be identified using a rank-based method developed by Dr. Hong (RankProd, R package, Bioconductor Project) with multiple comparison adjustment using a false discovery rate approach. A two-way unsupervised hierarchical clustering analysis will be applied to both the genes and the samples to illustrate whether GEP can separate two groups or is associated with other clinical factors. The genes ranked as most significant will be assessed by gene ontology and pathway analysis for their potential functions in lymphoma biology and treatment failure.	1 year
Microbiome analysis (Phase I and II) Временное ограничение: Completion of study treatment	Will compare the gut microbiome between Hodgkin lymphoma (HL) patients and healthy controls with respect to global diversity, taxonomic abundance, and bacterial functional pathways. The relative abundance of each taxon (phyla to genera) and functional pathways among different groups will be statistically compared in univariate analysis using t-test (or Wilcoxon test) and in multivariate analysis using logistic regression. Global diversity tests and multivariate analysis for taxonomic abundance and functional pathways will be adjusted for potential confounders (age, sex, race, and body mass index) in the comparisons of HL patients and controls, and further adjusted for stage and grade when examining the clinical response among HL patients.	Completion of study treatment
Absolute maximum standard uptake value (SUVmax) (Phase II) Временное ограничение: Up to cycle 10	Image data will be evaluated using Lugano response criteria with various D 5PS cut-offs in the entire cohort and in different therapy cohorts to determine if the existing set of criteria is sufficient to segregate the group into various response categories. Will correlate PFS, event free survival (EFS), OS 5PS in two reading settings (1-3 [negative] vs 4-5 [positive] and D 5PS 1-4 [negative] vs 5 [positive]) (Kaplan-Meier [KM] curve and log-rank testing).	Up to cycle 10
Metabolic whole body tumor volume (MTV) and tumor lesion glycolysis (TLG) Временное ограничение: Up to cycle 10	Image data will be evaluated using Lugano response criteria with various D 5PS cut-offs in the entire cohort and in different therapy cohorts to determine if the existing set of criteria is sufficient to segregate the group into various response categories. Will correlate PFS, EFS, OS 5PS in two reading settings (1-3 [negative] vs 4-5 [positive] and D 5PS 1-4 [negative] vs 5 [positive]) (KM curve and log-rank testing).	Up to cycle 10
Percent change in SUVmax, MTV and TLG between baseline and during therapy Временное ограничение: Baseline up to cycle 10	Image data will be evaluated using Lugano response criteria with various D 5PS cut-offs in the entire cohort and in different therapy cohorts to determine if the existing set of criteria is sufficient to segregate the group into various response categories. Will correlate PFS, EFS, OS 5PS in two reading settings (1-3 [negative] vs 4-5 [positive] and D 5PS 1-4 [negative] vs 5 [positive]) (KM curve and log-rank testing).	Baseline up to cycle 10
Percent change in size (sum of perpendicular diameters [SPD]) on computed tomography (CT) Временное ограничение: Baseline up to cycle 10	Image data will be evaluated using Lugano response criteria with various D 5PS cut-offs in the entire cohort and in different therapy cohorts to determine if the existing set of criteria is sufficient to segregate the group into various response categories. Will correlate PFS, EFS, OS 5PS in two reading settings (1-3 [negative] vs 4-5 [positive] and D 5PS 1-4 [negative] vs 5 [positive]) (KM curve and log-rank testing).	Baseline up to cycle 10
Absolute CT tumor volumes Временное ограничение: Up to cycle 10	Image data will be evaluated using Lugano response criteria with various D 5PS cut-offs in the entire cohort and in different therapy cohorts to determine if the existing set of criteria is sufficient to segregate the group into various response categories. Will correlate PFS, EFS, OS 5PS in two reading settings (1-3 [negative] vs 4-5 [positive] and D 5PS 1-4 [negative] vs 5 [positive]) (KM curve and log-rank testing).	Up to cycle 10
Percent change in CT size (SPD) and in CT tumor volume between baseline and during therapy Временное ограничение: Baseline up to cycle 10	Image data will be evaluated using Lugano response criteria with various D 5PS cut-offs in the entire cohort and in different therapy cohorts to determine if the existing set of criteria is sufficient to segregate the group into various response categories. Will correlate PFS, EFS, OS 5PS in two reading settings (1-3 [negative] vs 4-5 [positive] and D 5PS 1-4 [negative] vs 5 [positive]) (KM curve and log-rank testing).	Baseline up to cycle 10

Соавторы и исследователи

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Спонсор

National Cancer Institute (NCI)

Следователи

Главный следователь: Catherine S Diefenbach, ECOG-ACRIN Cancer Research Group

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

7 марта 2014 г.

Первичное завершение (Оцененный)

30 июня 2027 г.

Завершение исследования (Оцененный)

30 июня 2027 г.

Даты регистрации исследования

Первый отправленный

8 июля 2013 г.

Впервые представлено, что соответствует критериям контроля качества

8 июля 2013 г.

Первый опубликованный (Оцененный)

11 июля 2013 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

22 октября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

21 октября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

NCI-2013-01275
U10CA180820 (Грант/контракт NIH США)
U24CA196172 (Грант/контракт NIH США)
NCI-2013-01275 (Идентификатор реестра: CTRP (Clinical Trial Reporting Program))
E4412 (Другой идентификатор: CTEP)
S14-00011
E4412
E4412 (Другой идентификатор: ECOG-ACRIN Cancer Research Group)

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Брентуксимаб ведотин и ниволумаб с ипилимумабом или без него в лечении пациентов с рецидивирующей или рефрактерной лимфомой Ходжкина

Обзор исследования

Статус

Условия

Вмешательство/лечение

Подробное описание

Тип исследования

Регистрация (Оцененный)

Фаза

Контакты и местонахождение

Места учебы

Критерии участия

Критерии приемлемости

Возраст, подходящий для обучения

Принимает здоровых добровольцев

Полы, имеющие право на обучение

Описание

Учебный план

Как устроено исследование?

Детали дизайна

Количество рук

Оружие и интервенции

Группа участников / Армия

Вмешательство/лечение

Что измеряет исследование?

Первичные показатели результатов

Мера результата

Мера Описание

Временное ограничение

Вторичные показатели результатов

Мера результата

Мера Описание

Временное ограничение

Другие показатели результатов

Мера результата

Мера Описание

Временное ограничение

Соавторы и исследователи

Спонсор

Следователи

Публикации и полезные ссылки

Общие публикации

Даты записи исследования

Изучение основных дат

Начало исследования (Действительный)

Первичное завершение (Оцененный)

Завершение исследования (Оцененный)

Даты регистрации исследования

Первый отправленный

Впервые представлено, что соответствует критериям контроля качества

Первый опубликованный (Оцененный)

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

Последнее отправленное обновление, отвечающее критериям контроля качества

Последняя проверка

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования